Gynecology

Medical abortions using mifepristone and misoprostol to terminate a pregnancy up to 10 weeks of gestation were associated with similar rates of clinically significant adverse events whether the patient encounters occurred via telemedicine or in-office appointments, according to a retrospective cohort study published online in Obstetrics & Gynecology.

Among the 8,765 medical abortions associated with telemedicine visits and the 10,405 associated with in-person visits at Planned Parenthood of the Heartland clinics in Iowa during the 7-year study period, a total of 49 clinically significant adverse events (hospital admission, blood transfusion, treatment given in an emergency department) were reported. There were no surgeries or deaths in the cohort. Of telemedicine patients, 0.18% had any clinically adverse event (95% confidence interval, 0.11%-0.29%), compared with 0.32% of in-person patients (95% CI, 0.23%-0.45%), wrote Daniel Grossman, MD, of Advancing New Standards in Reproductive Health (ANSIRH), Bixby Center for Global Reproductive Health, Department of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Francisco, and Kate Grindlay, MSPH, of IBIS Reproductive Health, Cambridge, Mass.

“In the 2 years after telemedicine was introduced at [these] clinics, women had an almost 50% higher adjusted odds of obtaining a first trimester abortion instead of a second-trimester abortion, [which] is associated with a higher risk of complications,” Dr. Grossman and Dr. Grindlay wrote. “Rather than increasing risks of abortion, it may be that telemedicine provision of medical abortion helps to reduce such risks by improving access to early abortion.”

Dr. Grossman has served as a consultant to the Planned Parenthood Federation of America, providing input on the implementation of telemedicine services. Dr. Grindlay reported no financial disclosures.

Medical abortions using mifepristone and misoprostol to terminate a pregnancy up to 10 weeks of gestation were associated with similar rates of clinically significant adverse events whether the patient encounters occurred via telemedicine or in-office appointments, according to a retrospective cohort study published online in Obstetrics & Gynecology.

Among the 8,765 medical abortions associated with telemedicine visits and the 10,405 associated with in-person visits at Planned Parenthood of the Heartland clinics in Iowa during the 7-year study period, a total of 49 clinically significant adverse events (hospital admission, blood transfusion, treatment given in an emergency department) were reported. There were no surgeries or deaths in the cohort. Of telemedicine patients, 0.18% had any clinically adverse event (95% confidence interval, 0.11%-0.29%), compared with 0.32% of in-person patients (95% CI, 0.23%-0.45%), wrote Daniel Grossman, MD, of Advancing New Standards in Reproductive Health (ANSIRH), Bixby Center for Global Reproductive Health, Department of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Francisco, and Kate Grindlay, MSPH, of IBIS Reproductive Health, Cambridge, Mass.

“In the 2 years after telemedicine was introduced at [these] clinics, women had an almost 50% higher adjusted odds of obtaining a first trimester abortion instead of a second-trimester abortion, [which] is associated with a higher risk of complications,” Dr. Grossman and Dr. Grindlay wrote. “Rather than increasing risks of abortion, it may be that telemedicine provision of medical abortion helps to reduce such risks by improving access to early abortion.”

Dr. Grossman has served as a consultant to the Planned Parenthood Federation of America, providing input on the implementation of telemedicine services. Dr. Grindlay reported no financial disclosures.

Medical abortions using mifepristone and misoprostol to terminate a pregnancy up to 10 weeks of gestation were associated with similar rates of clinically significant adverse events whether the patient encounters occurred via telemedicine or in-office appointments, according to a retrospective cohort study published online in Obstetrics & Gynecology.

Among the 8,765 medical abortions associated with telemedicine visits and the 10,405 associated with in-person visits at Planned Parenthood of the Heartland clinics in Iowa during the 7-year study period, a total of 49 clinically significant adverse events (hospital admission, blood transfusion, treatment given in an emergency department) were reported. There were no surgeries or deaths in the cohort. Of telemedicine patients, 0.18% had any clinically adverse event (95% confidence interval, 0.11%-0.29%), compared with 0.32% of in-person patients (95% CI, 0.23%-0.45%), wrote Daniel Grossman, MD, of Advancing New Standards in Reproductive Health (ANSIRH), Bixby Center for Global Reproductive Health, Department of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Francisco, and Kate Grindlay, MSPH, of IBIS Reproductive Health, Cambridge, Mass.

“In the 2 years after telemedicine was introduced at [these] clinics, women had an almost 50% higher adjusted odds of obtaining a first trimester abortion instead of a second-trimester abortion, [which] is associated with a higher risk of complications,” Dr. Grossman and Dr. Grindlay wrote. “Rather than increasing risks of abortion, it may be that telemedicine provision of medical abortion helps to reduce such risks by improving access to early abortion.”

Dr. Grossman has served as a consultant to the Planned Parenthood Federation of America, providing input on the implementation of telemedicine services. Dr. Grindlay reported no financial disclosures.

ESTES PARK, CO. – When patients with interstitial cystitis (IC) learn that first-line therapy is a rigorous diet designed to eliminate common bladder irritants, they tend to react in one of two ways, according to Julie A. Chacko, MD, a urologist in private practice in Santa Barbara, Calif.

Some “are just so grateful that they’re not crazy, which is what they’ve been told after 15 negative urine cultures. (Others) “look at the diet and think I’m sentencing them to death,” she said.

The sole medication approved by the Food and Drug Administration for IC is pentosan polysulfate sodium (Elmiron), and it should be reserved for the minority of patients who don’t experience significant improvement after giving the diet a reasonable shot, Dr. Chako advised. “When Elmiron works it’s great, but it’s not usually my go-to agent because it’s very expensive, you have to take it for 3-6 months to know for sure if it’s efficacious, and it has to be taken on an empty stomach. It’s a difficult medication.”

A poorly understood yet common disorder, IC has a prevalence estimated at 0.5%-4% in women, less in men. Although typically diagnosed in the fourth decade or later, IC occurs at all ages. In some studies, the delay from first appearance of symptoms to arrival at a diagnosis is up to 8 years.

Interstitial cystitis is increasingly being called bladder pain syndrome in the literature, said Dr. Chako, who added, “I personally don’t love bladder pain syndrome as a description for this process. This syndrome has variable symptoms, and patients can have no pain at all.”

The mechanisms that result in IC are a mystery. The leading theory is that a bladder permeability problem allows urinary irritants to reach the interstitium. Nearly 80% of patients with IC can, with coaxing, identify dietary triggers for their symptoms, thereby basically establishing the diagnosis.

Other proposed mechanisms include an infectious agent that’s yet to be identified, allergic reaction, and neuromodulatory dysfunction. Common triggers other than foods include menses, copulation, emotional distress, and bladder trauma, including transvaginal ultrasound.

Conditions commonly associated with IC include fibromyalgia, irritable bowel syndrome, chronic fatigue, vulvodynia, migraines, depression, and anxiety.

The most common symptoms of IC are urinary urgency and frequency. Many affected patients have dysuria. Some have pain, which is typically suprapubic. However, pain can be present anywhere in a band circumscribing the whole central section of the torso, including the lower back, lower abdomen, urethra, vagina, and vulva. Patients describe a range of pain – burning, aching, stabbing, itching, buzzing, or a feeling of pressure.

“Most women who come in with IC are married to the idea that they’re having recurrent UTIs. They’re going to get antibiotics any way they can for their UTIs: over the phone, at urgent care. You need to get them to buy into the idea that even though UTIs are common, maybe not all of their flares are infections. They ask, ‘Then why do I feel better when I’m on antibiotics for recurrent UTI even though the cultures are negative?’ I say, ‘You feel less stress and anxiety because you think you’re on effective treatment,” Dr. Chacko said.

The diagnosis of IC is one of exclusions. Diagnoses to rule out before arriving at IC include recurrent UTI; overactive bladder, which should present with pure urge frequency and respond to medications for that condition; kidney stone disease present at the end of the ureter where it enters the bladder; gastrointestinal pathology; bladder cancer; and ovarian or uterine pathology.

Referral to a urologist for cystoscopy and cytology is appropriate in patients with microscopic hematuria, a significant smoking history predisposing to bladder cancer, or severe pain with severe frequency, which raises the possibility of Hunner’s ulcers, considered pathognomic for IC, respond “beautifully” to fulguration, she said.

Otherwise, IC can readily be managed by interested primary care physicians. The IC diet initially calls for 2 weeks of strict avoidance of all high-risk foods, most of which are acidic foods. These include fruits and fruit juices, especially citrus and cranberry juices; tomatoes and tomato products, including ketchup; yogurt; chocolate; coffee and tea, including decaf; vinegar; spicy foods; and carbonated beverages, water included.

These foods can later be added back one at a time to the diet while watching for IC flares, which typically occur within hours to several days of re-introducing the food. The return to coffee consumption, if that’s something important to the patient, should be with low-acid coffee. If that triggers an IC flare, try decaf. In time, many patients find they can consume some trigger foods in modest amounts.

“I tell patients it will take 12-18 months to get a good handle on their IC,” Dr. Chacko noted.

The use of OTC alkalizing agents such as Prelief may diffuse dietary triggers. A teaspoon of baking soda in water is also effective.

Second-line treatments include oral hydroxyzine 10-20 mg at bedtime; amitriptyline 10-20 mg at bedtime, mainly for patients with predominant pain symptoms; cimeditine; and pentosan polysulfate at 100 mg TID.

For IC patients with pelvic muscle tightness on pelvic examination, referral to a physical therapist adept at pelvic floor trigger point release can work wonders, she added.

One second-line option is bladder instillations of dimethyl sulfoxide weekly for 6 weeks, cutting back to once monthly maintenance therapy if the more intensive regimen is effective. Instillation of “heparin with lidocaine is a rescue solution. If it’s going to work, it kicks in within a few hours and usually lasts for 24-72 hours. It gets patients through a weekend, a wedding, or a funeral. A response can help make the IC diagnosis, too,” Dr. Chacko said.

She reported having no financial conflicts of interest regarding her presentation.
 

bjancin@frontlinemedcom.com


 

ESTES PARK, CO. – When patients with interstitial cystitis (IC) learn that first-line therapy is a rigorous diet designed to eliminate common bladder irritants, they tend to react in one of two ways, according to Julie A. Chacko, MD, a urologist in private practice in Santa Barbara, Calif.

Some “are just so grateful that they’re not crazy, which is what they’ve been told after 15 negative urine cultures. (Others) “look at the diet and think I’m sentencing them to death,” she said.

The sole medication approved by the Food and Drug Administration for IC is pentosan polysulfate sodium (Elmiron), and it should be reserved for the minority of patients who don’t experience significant improvement after giving the diet a reasonable shot, Dr. Chako advised. “When Elmiron works it’s great, but it’s not usually my go-to agent because it’s very expensive, you have to take it for 3-6 months to know for sure if it’s efficacious, and it has to be taken on an empty stomach. It’s a difficult medication.”

A poorly understood yet common disorder, IC has a prevalence estimated at 0.5%-4% in women, less in men. Although typically diagnosed in the fourth decade or later, IC occurs at all ages. In some studies, the delay from first appearance of symptoms to arrival at a diagnosis is up to 8 years.

Interstitial cystitis is increasingly being called bladder pain syndrome in the literature, said Dr. Chako, who added, “I personally don’t love bladder pain syndrome as a description for this process. This syndrome has variable symptoms, and patients can have no pain at all.”

The mechanisms that result in IC are a mystery. The leading theory is that a bladder permeability problem allows urinary irritants to reach the interstitium. Nearly 80% of patients with IC can, with coaxing, identify dietary triggers for their symptoms, thereby basically establishing the diagnosis.

Other proposed mechanisms include an infectious agent that’s yet to be identified, allergic reaction, and neuromodulatory dysfunction. Common triggers other than foods include menses, copulation, emotional distress, and bladder trauma, including transvaginal ultrasound.

Conditions commonly associated with IC include fibromyalgia, irritable bowel syndrome, chronic fatigue, vulvodynia, migraines, depression, and anxiety.

The most common symptoms of IC are urinary urgency and frequency. Many affected patients have dysuria. Some have pain, which is typically suprapubic. However, pain can be present anywhere in a band circumscribing the whole central section of the torso, including the lower back, lower abdomen, urethra, vagina, and vulva. Patients describe a range of pain – burning, aching, stabbing, itching, buzzing, or a feeling of pressure.

“Most women who come in with IC are married to the idea that they’re having recurrent UTIs. They’re going to get antibiotics any way they can for their UTIs: over the phone, at urgent care. You need to get them to buy into the idea that even though UTIs are common, maybe not all of their flares are infections. They ask, ‘Then why do I feel better when I’m on antibiotics for recurrent UTI even though the cultures are negative?’ I say, ‘You feel less stress and anxiety because you think you’re on effective treatment,” Dr. Chacko said.

The diagnosis of IC is one of exclusions. Diagnoses to rule out before arriving at IC include recurrent UTI; overactive bladder, which should present with pure urge frequency and respond to medications for that condition; kidney stone disease present at the end of the ureter where it enters the bladder; gastrointestinal pathology; bladder cancer; and ovarian or uterine pathology.

Referral to a urologist for cystoscopy and cytology is appropriate in patients with microscopic hematuria, a significant smoking history predisposing to bladder cancer, or severe pain with severe frequency, which raises the possibility of Hunner’s ulcers, considered pathognomic for IC, respond “beautifully” to fulguration, she said.

Otherwise, IC can readily be managed by interested primary care physicians. The IC diet initially calls for 2 weeks of strict avoidance of all high-risk foods, most of which are acidic foods. These include fruits and fruit juices, especially citrus and cranberry juices; tomatoes and tomato products, including ketchup; yogurt; chocolate; coffee and tea, including decaf; vinegar; spicy foods; and carbonated beverages, water included.

These foods can later be added back one at a time to the diet while watching for IC flares, which typically occur within hours to several days of re-introducing the food. The return to coffee consumption, if that’s something important to the patient, should be with low-acid coffee. If that triggers an IC flare, try decaf. In time, many patients find they can consume some trigger foods in modest amounts.

“I tell patients it will take 12-18 months to get a good handle on their IC,” Dr. Chacko noted.

The use of OTC alkalizing agents such as Prelief may diffuse dietary triggers. A teaspoon of baking soda in water is also effective.

Second-line treatments include oral hydroxyzine 10-20 mg at bedtime; amitriptyline 10-20 mg at bedtime, mainly for patients with predominant pain symptoms; cimeditine; and pentosan polysulfate at 100 mg TID.

For IC patients with pelvic muscle tightness on pelvic examination, referral to a physical therapist adept at pelvic floor trigger point release can work wonders, she added.

One second-line option is bladder instillations of dimethyl sulfoxide weekly for 6 weeks, cutting back to once monthly maintenance therapy if the more intensive regimen is effective. Instillation of “heparin with lidocaine is a rescue solution. If it’s going to work, it kicks in within a few hours and usually lasts for 24-72 hours. It gets patients through a weekend, a wedding, or a funeral. A response can help make the IC diagnosis, too,” Dr. Chacko said.

She reported having no financial conflicts of interest regarding her presentation.
 

bjancin@frontlinemedcom.com


 

ESTES PARK, CO. – When patients with interstitial cystitis (IC) learn that first-line therapy is a rigorous diet designed to eliminate common bladder irritants, they tend to react in one of two ways, according to Julie A. Chacko, MD, a urologist in private practice in Santa Barbara, Calif.

Some “are just so grateful that they’re not crazy, which is what they’ve been told after 15 negative urine cultures. (Others) “look at the diet and think I’m sentencing them to death,” she said.

The sole medication approved by the Food and Drug Administration for IC is pentosan polysulfate sodium (Elmiron), and it should be reserved for the minority of patients who don’t experience significant improvement after giving the diet a reasonable shot, Dr. Chako advised. “When Elmiron works it’s great, but it’s not usually my go-to agent because it’s very expensive, you have to take it for 3-6 months to know for sure if it’s efficacious, and it has to be taken on an empty stomach. It’s a difficult medication.”

A poorly understood yet common disorder, IC has a prevalence estimated at 0.5%-4% in women, less in men. Although typically diagnosed in the fourth decade or later, IC occurs at all ages. In some studies, the delay from first appearance of symptoms to arrival at a diagnosis is up to 8 years.

Interstitial cystitis is increasingly being called bladder pain syndrome in the literature, said Dr. Chako, who added, “I personally don’t love bladder pain syndrome as a description for this process. This syndrome has variable symptoms, and patients can have no pain at all.”

The mechanisms that result in IC are a mystery. The leading theory is that a bladder permeability problem allows urinary irritants to reach the interstitium. Nearly 80% of patients with IC can, with coaxing, identify dietary triggers for their symptoms, thereby basically establishing the diagnosis.

Other proposed mechanisms include an infectious agent that’s yet to be identified, allergic reaction, and neuromodulatory dysfunction. Common triggers other than foods include menses, copulation, emotional distress, and bladder trauma, including transvaginal ultrasound.

Conditions commonly associated with IC include fibromyalgia, irritable bowel syndrome, chronic fatigue, vulvodynia, migraines, depression, and anxiety.

The most common symptoms of IC are urinary urgency and frequency. Many affected patients have dysuria. Some have pain, which is typically suprapubic. However, pain can be present anywhere in a band circumscribing the whole central section of the torso, including the lower back, lower abdomen, urethra, vagina, and vulva. Patients describe a range of pain – burning, aching, stabbing, itching, buzzing, or a feeling of pressure.

“Most women who come in with IC are married to the idea that they’re having recurrent UTIs. They’re going to get antibiotics any way they can for their UTIs: over the phone, at urgent care. You need to get them to buy into the idea that even though UTIs are common, maybe not all of their flares are infections. They ask, ‘Then why do I feel better when I’m on antibiotics for recurrent UTI even though the cultures are negative?’ I say, ‘You feel less stress and anxiety because you think you’re on effective treatment,” Dr. Chacko said.

The diagnosis of IC is one of exclusions. Diagnoses to rule out before arriving at IC include recurrent UTI; overactive bladder, which should present with pure urge frequency and respond to medications for that condition; kidney stone disease present at the end of the ureter where it enters the bladder; gastrointestinal pathology; bladder cancer; and ovarian or uterine pathology.

Referral to a urologist for cystoscopy and cytology is appropriate in patients with microscopic hematuria, a significant smoking history predisposing to bladder cancer, or severe pain with severe frequency, which raises the possibility of Hunner’s ulcers, considered pathognomic for IC, respond “beautifully” to fulguration, she said.

Otherwise, IC can readily be managed by interested primary care physicians. The IC diet initially calls for 2 weeks of strict avoidance of all high-risk foods, most of which are acidic foods. These include fruits and fruit juices, especially citrus and cranberry juices; tomatoes and tomato products, including ketchup; yogurt; chocolate; coffee and tea, including decaf; vinegar; spicy foods; and carbonated beverages, water included.

These foods can later be added back one at a time to the diet while watching for IC flares, which typically occur within hours to several days of re-introducing the food. The return to coffee consumption, if that’s something important to the patient, should be with low-acid coffee. If that triggers an IC flare, try decaf. In time, many patients find they can consume some trigger foods in modest amounts.

“I tell patients it will take 12-18 months to get a good handle on their IC,” Dr. Chacko noted.

The use of OTC alkalizing agents such as Prelief may diffuse dietary triggers. A teaspoon of baking soda in water is also effective.

Second-line treatments include oral hydroxyzine 10-20 mg at bedtime; amitriptyline 10-20 mg at bedtime, mainly for patients with predominant pain symptoms; cimeditine; and pentosan polysulfate at 100 mg TID.

For IC patients with pelvic muscle tightness on pelvic examination, referral to a physical therapist adept at pelvic floor trigger point release can work wonders, she added.

One second-line option is bladder instillations of dimethyl sulfoxide weekly for 6 weeks, cutting back to once monthly maintenance therapy if the more intensive regimen is effective. Instillation of “heparin with lidocaine is a rescue solution. If it’s going to work, it kicks in within a few hours and usually lasts for 24-72 hours. It gets patients through a weekend, a wedding, or a funeral. A response can help make the IC diagnosis, too,” Dr. Chacko said.

She reported having no financial conflicts of interest regarding her presentation.
 

bjancin@frontlinemedcom.com


 

Illustration: Kimberly Martens for OBG Management

Sexual function is a complex, multifaceted process mediated by neurologic functions, hormonal regulation, and psychological factors. What could possibly go wrong?

As it turns out, quite a lot. Female sexual dysfunction is a common, vastly undertreated sexual health problem that can have wide-reaching effects on a woman’s life. These effects may include impaired body image, self-confidence, and self-worth. Sexual dysfunction also can contribute to relationship dissatisfaction and leave one feeling less connected with her partner.^1,2 Studies have shown women with sexual dysfunction have higher health care expenditures³ and that depression and fatigue are common comorbidities, as is frequently seen in other chronic conditions such as diabetes and back pain.⁴

Understanding the pathogenesis of female sexual dysfunction helps to guide our approach to its management. Indeed, increased understanding of its pathology has helped to usher in new and emerging treatment options, as well as a personalized, biopsychosocial approach to its management.

Related article:
2016 Update on female sexual dysfunction

In this Update, I discuss the interplay of physiologic and psychological factors that affect female sexual function as well as the latest options for its management. I have also assembled a panel of experts to discuss 2 cases representative of sexual dysfunction that you may encounter in your clinical practice and how prescribing decisions are made for their management.

Read about factors that impact sexual function and agents to help manage dysfunction.

Multiple transmitters in the brain can increase or decrease sexual desire and function

Neurotransmitters involved in sexual excitation include brain dopamine, melanocortin, oxytocin, vasopressin, and norepinephrine, whereas brain opioids, serotonin, prolactin, and endocannabinoids function as sexual inhibitors. Inhibitory transmitters are activated normally during sexual refractoriness but also from primary aversion or secondary avoidance disorders.¹ Drugs or conditions that reduce brain dopamine levels, increase the action of brain serotonin, or enhance brain opioid pathways have been shown to inhibit sexual desire, while those that increase hypothalamic and mesolimbic dopamine or decrease serotonin release have been shown to stimulate sexual desire.¹ 

Estradiol and progesterone can impact sexual function and desire

In addition to the neurotransmitters, hormones are important modulators of female sexual function. Decreasing levels of circulating estrogen after menopause lead to physiologic, biologic, and clinical changes in the urogenital tissues, such as decreased elastin, thinning of the epithelium, reduced vaginal blood flow, diminished lubrication, and decreased flexibility and elasticity. These changes result in the symptoms of genitourinary syndrome of menopause (GSM), which affects as many as half of all menopausal women.^5,6 In clinical trials, dyspareunia and vaginal dryness are the most bothersome GSM symptoms reported.⁷

The role of hormonal regulation in sexual dysfunction among premenopausal women is not yet fully understood, but we do know that estradiol has been shown to improve sexual desire, progesterone tends to dampen sexual desire, and that testosterone at physiological levels has been shown in most studies to have a neutral effect on sexual desire in a well-estrogenized patient.⁸

Related article:
Focus on treating genital atrophy symptoms

Experience and behavior modulate or reinforce sexual dysfunction

The most common psychological factors that trigger or amplify female sexual dysfunction are depression, anxiety, distraction, negative body image, sexual abuse, and emotional neglect.⁹ Contextual or sociocultural factors, such as relationship discord, life-stage stressors (the empty nest syndrome or anxiety and sleep deprivation from a new baby), as well as cultural or religious values that suppress sexuality, also should be considered.⁹ Experience-based neuroplasticity (changes in brain pathways that become solidified by negative or positive experiences) may elucidate how a multimodal approach, utilizing medical and psychological treatment, can be beneficial for patients, particularly those with hypoactive sexual desire disorder (HSDD).¹

New and emerging approaches to managing female sexual dysfunction

Three agents, one of which has been available for prescription for some time, one that is newly available, and one in the pipeline, are or may soon be in the gynecologist's armamentarium.

Flibanserin

Medications that target excitatory pathways or blunt inhibitory pathways are in development, and one, flibanserin (Addyi), has been US Food and Drug Administration (FDA)-approved for the treatment of acquired, generalized HSDD in premenopausal women.^1,10 Flibanserin is a nonhormonal, centrally acting, postsynaptic serotonin 1A receptor agonist and a serotonin 2A receptor antagonist that is taken daily at bedtime (100 mg); several weeks are usually needed before any effects are noted.¹ It is not approved for postmenopausal women and has a boxed warning about the risks of hypotension and syncope; its use is contraindicated in women who drink alcohol, in those who have hepatic impairment, and with the use of moderate or strong CYP3A4 inhibitors.¹¹

Also keep in mind that flibanserin is only available through a Risk Evaluation and Mitigation Strategy program, so clinicians who wish to prescribe it must enroll in and complete training to become certified providers.⁹

Related article:
What you need to know (and do) to prescribe the new drug flibanserin

Prasterone

Prasterone (Intrarosa), a once-daily intravaginal dehydroepiandrosterone (DHEA) product, is a prohormone that increases local estrogen and testosterone and has the advantage of improved sexual function, desire, arousal, lubrication, orgasm, satisfaction, as well as pain at sexual activity.¹² It was approved by the FDA in November 2016 to treat moderate to severe dyspareunia and has been available for prescribing since July 2017. Its cost is comparable to topical estrogen products, with a $25 copay program.

Because prasterone is not an estrogen, it does not have the boxed warning that all estrogen products are mandated by the FDA to have. This may make it more acceptable to patients, who often decline to use an estrogen product after seeing the boxed warning on the package. The Centers for Medicare and Medicaid Services (CMS) does not have prasterone on its list of potentially hazardous drugs for the elderly. However, keep in mind that because its label is for dyspareunia and not specifically for GSM, CMS considers it a drug of choice--in other words, like sildenafil (Viagra), a lifestyle choice and not for treatment of a medical condition. As such, at the present time, Medicare does not cover it.

Bremelanotide

Late-stage trials of bremelanotide, a melanocortin receptor agonist, are underway. Its mechanism of action is somewhat like that of flibanserin in that both drugs increase dopamine and norepinephrine levels. The advantage of bremelanotide is that it is used as needed. It is dosed subcutaneously (1.75 mg) and it can be used as often as a woman would like to use it. The FDA is expected to consider it for approval in about a year. Unpublished data from poster sessions at recent meetings show that, in a phase 3 study of 1,247 premenopausal women with HSDD (who had already been screened for depression and were found to have a physiologic condition), improvements in desire, arousal, lubrication, and orgasm were shown with bremelanotide. About 18% of women stopped using the drug because of adverse effects (nausea, vomiting, flushing, or headache) versus 2% for placebo. Like flibanserin, it is expected to be approved for premenopausal women only. 

Read how 3 experts would manage differing GSM symptoms.

What would you prescribe for these patients? 

CASE Genitourinary syndrome of menopause (GSM) in a 55-year-old woman

A 55-year-old widow is beginning a new relationship. She has not had partnered sexual activity for several years, but she recently has begun a relationship. She describes pain with attempted penetration with her new partner. Her last menstrual period was 3 years ago and she has experienced very minor menopausal symptoms, which are not bothersome. On examination, the vulva and vagina are pale, with thin epithelium and absent rugae. The tissue lacks elasticity. A virginal speculum is needed to visualize the cervix.

How would you go about deciding which of the many options for management of GSM you will recommend for this patient? What do you weigh as you consider DHEA versus estrogen and topical versus oral therapy?
 
JoAnn V. Pinkerton, MD: Vulvovaginal atrophy (VVA), part of GSM, is associated with postmenopausal estrogen deficiency and includes the signs and symptoms seen on this patient's physical exam: vaginal narrowing, pallor, loss of elasticity, as well as pain with intercourse.⁶ Estrogen therapy is the most effective treatment for vaginal atrophy.¹³ Since she does not have significant menopausal symptoms, low-dose vaginal estrogen preparations are effective and generally safe treatments for VVA; these include creams, tablets containing estradiol or conjugated equine estrogen (CEE), and a low-dose vaginal estradiol ring--all available at doses that result in minimal systemic absorption.

Choice is usually made based on patient desire and likely adherence. If the patient prefers nonestrogen therapies that improve VVA and have been approved for relief of dyspareunia in postmenopausal women, I would discuss with the patient the oral selective estrogen receptor modulator ospemifene,¹⁴ and the new intravaginal DHEA suppositories, prasterone.¹⁵ Ospemifene is taken daily as an oral tablet, has a small risk of blood clots, and is my choice for women who do not need systemic hormone therapy and prefer to avoid vaginal therapy.

Andrew M. Kaunitz, MD: GSM is prevalent in menopausal women and, if not treated, causes progressive vaginal dryness and sexual discomfort. When the main indication for hormonal management in a menopausal woman is GSM (as opposed to treatment of vasomotor symptoms or prevention of osteoporosis), the treatment of choice is low-dose local vaginal estrogen, ospemifene, or prasterone (DHEA). Prasterone is a vaginally administered nonestrogen steroid that was approved by the FDA to treat dyspareunia associated with GSM. DHEA is an endogenous inactive steroid that is converted locally into androgens and estrogens; one vaginal insert is placed nightly.^16,17

This 55-year-old widow has not been sexually active for some time. The facts that attempted penetration was painful and only an ultrathin (virginal) speculum could be used for examination indicate that contraction of the pelvic floor muscles is likely present. Simply starting medical management may not lead to comfortable/successful penetrative sex for this woman. In addition to  medical management, she would likely benefit from referral for physical therapy. Using dilators and other strategies, along with the positive impact that medical management will have on the vaginal mucosa, a woman's physical therapist can work with this patient to help the pelvic floor muscles relax and facilitate comfortable penetrative sex.

James A. Simon, MD: With only minor vasomotor symptoms, I would assess the other potential benefits of a systemic therapy. These might include cardiovascular risk reduction (systemic estrogens or estrogens/progesterone in some), breast cancer risk reduction (some data suggesting ospemifene can accomplish this), osteoporosis prevention (systemic estrogens and estrogen/androgens), etc. If there is an option for a treatment to address more than one symptom, in this case GSM, assessing the risks/benefits of each of these therapies should be estimated for this specific patient.

If there are no systemic benefits to be had, then any of the local treatments should be helpful. As there are no head-to-head comparisons available, local estrogen cream, tablets, rings, local DHEA, or systemic ospemifene each should be considered possible treatments. I also feel this patient may benefit from supplementary self-dilation and/or physical therapy.

Related article:
2017 Update on menopause

 
CASE Dyspareunia and vasomotor symptoms in a 42-year-old breast cancer survivor

A 42-year-old woman with a BRCA1 mutation has undergone prophylactic mastectomies as well as hysterectomy with bilateral salpingo-oophorectomy. She reports mild to moderate hot flashes and bothersome vaginal dryness and dyspareunia. Examination confirms GSM.

Would you advise systemic hormone therapy for this patient? What would your recommendation be for management of her GSM symptoms?

Dr. Simon: While one's gut reaction would be to avoid systemic estrogen therapy in a patient with a BRCA1 mutation, the scientific information confirming this fear is lacking.¹⁸ Such patients may benefit significantly from systemic estrogen therapy (reduced risk of cardiovascular disease and cognitive decline, etc.), and with both breasts and both ovaries removed, estrogen's breast cancer risks, if any in this population, are largely avoided. The patient also may benefit from additional local therapy with either estrogens or DHEA.

Dr. Kaunitz: Due to her high lifetime risk of breast and ovarian cancer, this woman has proceeded with risk-reducing breast and gynecologic surgery. As more BRCA mutation carriers are being identified and undergo risk-reducing bilateral mastectomy (usually with reconstruction) and salpingo-oophorectomy, clinicians and mutation carriers more frequently face decisions regarding use of systemic hormone therapy.

Mutation carriers who have undergone bilateral risk-reducing mastectomy experience a very low baseline future risk for breast cancer; accordingly, concerns regarding this disease should not prevent use of systemic hormone therapy. Furthermore, without hormone replacement, induced menopause in women this age is associated with an elevated risk of osteoporosis, persistent vasomotor symptoms, cardiovascular disease, stroke, mood changes, dementia, Parkinson disease, and overall mortality. Recognizing the safety of estrogen therapy in this setting, this 42-year-old BRCA1 mutation carrier can initiate estrogen therapy. Standard dose estrogen therapy refers to oral estradiol 1.0 mg, conjugated equine estrogen 0.625 mg,or transdermal estradiol 0.05 mg. In younger women like this 42-year-old with surgically induced menopause, higher than standard replacement doses of estrogen are often appropriate.¹⁷

Due to concerns the hormone therapy might further increase future risk of breast cancer, some mutation carriers may delay or avoid risk-reducing bilateral salpingo-oophorectomy, a potentially lifesaving surgery which reduces not only future risk of ovarian cancer but also future risk for breast cancer.

Among mutation carriers with intact breasts, several studies address risk of breast cancer with use of systemic hormone therapy. Although limited in numbers of participants and years of follow-up, in aggregate, these studies provide reassurance that short-term use of systemic hormone therapy does not increase breast cancer risk in women with BRCA1 or BRCA2 mutations and intact breasts.¹⁹

Dr. Pinkerton: For this woman with early surgical menopause and hysterectomy, estrogen therapy could improve her vasomotor symptoms and decrease her risk of bone loss and GSM.¹⁷ In the Women's Health Initiative trial, there were 7 fewer breast cancers per 10,000 women-years in the estrogen-onlyarm.²⁰ Observational studies suggest that hormone therapy, when given to the average age of menopause, decreases the risks of heart disease, Parkinson disease, and dementia.²¹ Limited observational evidence suggests that hormone therapy use does not further increase risk of breast cancer in women following oophorectomy for BRCA1 or BRCA2 gene mutation.²²

The absolute risks observed with hormone therapy tended to be small, especially in younger, healthy women. Systemic hormone therapy could treat her hot flashes and her GSM symptoms and potentially decrease health risks associated with premature estrogen deficiency. Nonestrogen therapies for hot flashes include low-dose antidepressants, gabapentin, and mind-body options, such as cognitive behavioral therapy and hypnosis, but these would not decrease her health risks or treat her GSM.

If she only requests treatment of her GSM symptoms, she would be a candidate for low-dose vaginal estrogen therapy, given as a cream, tablet, or ring depending on her choice. I would not choose ospemifene as my first choice as she is having hot flashes, and there are no data yet on the drug's health benefits in early menopause. If she prefers nonestrogen vaginal therapy, the new intravaginal DHEA might be a good choice as both estrogen and testosterone are increased locally in the vagina while hormone levels remain in the postmenopausal range. There is no boxed warning on the patient insert, although safety in women with breast cancer or in those with elevated risk of breast cancer has not been tested.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

Illustration: Kimberly Martens for OBG Management

Sexual function is a complex, multifaceted process mediated by neurologic functions, hormonal regulation, and psychological factors. What could possibly go wrong?

As it turns out, quite a lot. Female sexual dysfunction is a common, vastly undertreated sexual health problem that can have wide-reaching effects on a woman’s life. These effects may include impaired body image, self-confidence, and self-worth. Sexual dysfunction also can contribute to relationship dissatisfaction and leave one feeling less connected with her partner.^1,2 Studies have shown women with sexual dysfunction have higher health care expenditures³ and that depression and fatigue are common comorbidities, as is frequently seen in other chronic conditions such as diabetes and back pain.⁴

Understanding the pathogenesis of female sexual dysfunction helps to guide our approach to its management. Indeed, increased understanding of its pathology has helped to usher in new and emerging treatment options, as well as a personalized, biopsychosocial approach to its management.

Related article:
2016 Update on female sexual dysfunction

In this Update, I discuss the interplay of physiologic and psychological factors that affect female sexual function as well as the latest options for its management. I have also assembled a panel of experts to discuss 2 cases representative of sexual dysfunction that you may encounter in your clinical practice and how prescribing decisions are made for their management.

Read about factors that impact sexual function and agents to help manage dysfunction.

Multiple transmitters in the brain can increase or decrease sexual desire and function

Neurotransmitters involved in sexual excitation include brain dopamine, melanocortin, oxytocin, vasopressin, and norepinephrine, whereas brain opioids, serotonin, prolactin, and endocannabinoids function as sexual inhibitors. Inhibitory transmitters are activated normally during sexual refractoriness but also from primary aversion or secondary avoidance disorders.¹ Drugs or conditions that reduce brain dopamine levels, increase the action of brain serotonin, or enhance brain opioid pathways have been shown to inhibit sexual desire, while those that increase hypothalamic and mesolimbic dopamine or decrease serotonin release have been shown to stimulate sexual desire.¹ 

Estradiol and progesterone can impact sexual function and desire

In addition to the neurotransmitters, hormones are important modulators of female sexual function. Decreasing levels of circulating estrogen after menopause lead to physiologic, biologic, and clinical changes in the urogenital tissues, such as decreased elastin, thinning of the epithelium, reduced vaginal blood flow, diminished lubrication, and decreased flexibility and elasticity. These changes result in the symptoms of genitourinary syndrome of menopause (GSM), which affects as many as half of all menopausal women.^5,6 In clinical trials, dyspareunia and vaginal dryness are the most bothersome GSM symptoms reported.⁷

The role of hormonal regulation in sexual dysfunction among premenopausal women is not yet fully understood, but we do know that estradiol has been shown to improve sexual desire, progesterone tends to dampen sexual desire, and that testosterone at physiological levels has been shown in most studies to have a neutral effect on sexual desire in a well-estrogenized patient.⁸

Related article:
Focus on treating genital atrophy symptoms

Experience and behavior modulate or reinforce sexual dysfunction

The most common psychological factors that trigger or amplify female sexual dysfunction are depression, anxiety, distraction, negative body image, sexual abuse, and emotional neglect.⁹ Contextual or sociocultural factors, such as relationship discord, life-stage stressors (the empty nest syndrome or anxiety and sleep deprivation from a new baby), as well as cultural or religious values that suppress sexuality, also should be considered.⁹ Experience-based neuroplasticity (changes in brain pathways that become solidified by negative or positive experiences) may elucidate how a multimodal approach, utilizing medical and psychological treatment, can be beneficial for patients, particularly those with hypoactive sexual desire disorder (HSDD).¹

New and emerging approaches to managing female sexual dysfunction

Three agents, one of which has been available for prescription for some time, one that is newly available, and one in the pipeline, are or may soon be in the gynecologist's armamentarium.

Flibanserin

Medications that target excitatory pathways or blunt inhibitory pathways are in development, and one, flibanserin (Addyi), has been US Food and Drug Administration (FDA)-approved for the treatment of acquired, generalized HSDD in premenopausal women.^1,10 Flibanserin is a nonhormonal, centrally acting, postsynaptic serotonin 1A receptor agonist and a serotonin 2A receptor antagonist that is taken daily at bedtime (100 mg); several weeks are usually needed before any effects are noted.¹ It is not approved for postmenopausal women and has a boxed warning about the risks of hypotension and syncope; its use is contraindicated in women who drink alcohol, in those who have hepatic impairment, and with the use of moderate or strong CYP3A4 inhibitors.¹¹

Also keep in mind that flibanserin is only available through a Risk Evaluation and Mitigation Strategy program, so clinicians who wish to prescribe it must enroll in and complete training to become certified providers.⁹

Related article:
What you need to know (and do) to prescribe the new drug flibanserin

Prasterone

Prasterone (Intrarosa), a once-daily intravaginal dehydroepiandrosterone (DHEA) product, is a prohormone that increases local estrogen and testosterone and has the advantage of improved sexual function, desire, arousal, lubrication, orgasm, satisfaction, as well as pain at sexual activity.¹² It was approved by the FDA in November 2016 to treat moderate to severe dyspareunia and has been available for prescribing since July 2017. Its cost is comparable to topical estrogen products, with a $25 copay program.

Because prasterone is not an estrogen, it does not have the boxed warning that all estrogen products are mandated by the FDA to have. This may make it more acceptable to patients, who often decline to use an estrogen product after seeing the boxed warning on the package. The Centers for Medicare and Medicaid Services (CMS) does not have prasterone on its list of potentially hazardous drugs for the elderly. However, keep in mind that because its label is for dyspareunia and not specifically for GSM, CMS considers it a drug of choice--in other words, like sildenafil (Viagra), a lifestyle choice and not for treatment of a medical condition. As such, at the present time, Medicare does not cover it.

Bremelanotide

Late-stage trials of bremelanotide, a melanocortin receptor agonist, are underway. Its mechanism of action is somewhat like that of flibanserin in that both drugs increase dopamine and norepinephrine levels. The advantage of bremelanotide is that it is used as needed. It is dosed subcutaneously (1.75 mg) and it can be used as often as a woman would like to use it. The FDA is expected to consider it for approval in about a year. Unpublished data from poster sessions at recent meetings show that, in a phase 3 study of 1,247 premenopausal women with HSDD (who had already been screened for depression and were found to have a physiologic condition), improvements in desire, arousal, lubrication, and orgasm were shown with bremelanotide. About 18% of women stopped using the drug because of adverse effects (nausea, vomiting, flushing, or headache) versus 2% for placebo. Like flibanserin, it is expected to be approved for premenopausal women only. 

Read how 3 experts would manage differing GSM symptoms.

What would you prescribe for these patients? 

CASE Genitourinary syndrome of menopause (GSM) in a 55-year-old woman

A 55-year-old widow is beginning a new relationship. She has not had partnered sexual activity for several years, but she recently has begun a relationship. She describes pain with attempted penetration with her new partner. Her last menstrual period was 3 years ago and she has experienced very minor menopausal symptoms, which are not bothersome. On examination, the vulva and vagina are pale, with thin epithelium and absent rugae. The tissue lacks elasticity. A virginal speculum is needed to visualize the cervix.

How would you go about deciding which of the many options for management of GSM you will recommend for this patient? What do you weigh as you consider DHEA versus estrogen and topical versus oral therapy?
 
JoAnn V. Pinkerton, MD: Vulvovaginal atrophy (VVA), part of GSM, is associated with postmenopausal estrogen deficiency and includes the signs and symptoms seen on this patient's physical exam: vaginal narrowing, pallor, loss of elasticity, as well as pain with intercourse.⁶ Estrogen therapy is the most effective treatment for vaginal atrophy.¹³ Since she does not have significant menopausal symptoms, low-dose vaginal estrogen preparations are effective and generally safe treatments for VVA; these include creams, tablets containing estradiol or conjugated equine estrogen (CEE), and a low-dose vaginal estradiol ring--all available at doses that result in minimal systemic absorption.

Choice is usually made based on patient desire and likely adherence. If the patient prefers nonestrogen therapies that improve VVA and have been approved for relief of dyspareunia in postmenopausal women, I would discuss with the patient the oral selective estrogen receptor modulator ospemifene,¹⁴ and the new intravaginal DHEA suppositories, prasterone.¹⁵ Ospemifene is taken daily as an oral tablet, has a small risk of blood clots, and is my choice for women who do not need systemic hormone therapy and prefer to avoid vaginal therapy.

Andrew M. Kaunitz, MD: GSM is prevalent in menopausal women and, if not treated, causes progressive vaginal dryness and sexual discomfort. When the main indication for hormonal management in a menopausal woman is GSM (as opposed to treatment of vasomotor symptoms or prevention of osteoporosis), the treatment of choice is low-dose local vaginal estrogen, ospemifene, or prasterone (DHEA). Prasterone is a vaginally administered nonestrogen steroid that was approved by the FDA to treat dyspareunia associated with GSM. DHEA is an endogenous inactive steroid that is converted locally into androgens and estrogens; one vaginal insert is placed nightly.^16,17

This 55-year-old widow has not been sexually active for some time. The facts that attempted penetration was painful and only an ultrathin (virginal) speculum could be used for examination indicate that contraction of the pelvic floor muscles is likely present. Simply starting medical management may not lead to comfortable/successful penetrative sex for this woman. In addition to  medical management, she would likely benefit from referral for physical therapy. Using dilators and other strategies, along with the positive impact that medical management will have on the vaginal mucosa, a woman's physical therapist can work with this patient to help the pelvic floor muscles relax and facilitate comfortable penetrative sex.

James A. Simon, MD: With only minor vasomotor symptoms, I would assess the other potential benefits of a systemic therapy. These might include cardiovascular risk reduction (systemic estrogens or estrogens/progesterone in some), breast cancer risk reduction (some data suggesting ospemifene can accomplish this), osteoporosis prevention (systemic estrogens and estrogen/androgens), etc. If there is an option for a treatment to address more than one symptom, in this case GSM, assessing the risks/benefits of each of these therapies should be estimated for this specific patient.

If there are no systemic benefits to be had, then any of the local treatments should be helpful. As there are no head-to-head comparisons available, local estrogen cream, tablets, rings, local DHEA, or systemic ospemifene each should be considered possible treatments. I also feel this patient may benefit from supplementary self-dilation and/or physical therapy.

Related article:
2017 Update on menopause

 
CASE Dyspareunia and vasomotor symptoms in a 42-year-old breast cancer survivor

A 42-year-old woman with a BRCA1 mutation has undergone prophylactic mastectomies as well as hysterectomy with bilateral salpingo-oophorectomy. She reports mild to moderate hot flashes and bothersome vaginal dryness and dyspareunia. Examination confirms GSM.

Would you advise systemic hormone therapy for this patient? What would your recommendation be for management of her GSM symptoms?

Dr. Simon: While one's gut reaction would be to avoid systemic estrogen therapy in a patient with a BRCA1 mutation, the scientific information confirming this fear is lacking.¹⁸ Such patients may benefit significantly from systemic estrogen therapy (reduced risk of cardiovascular disease and cognitive decline, etc.), and with both breasts and both ovaries removed, estrogen's breast cancer risks, if any in this population, are largely avoided. The patient also may benefit from additional local therapy with either estrogens or DHEA.

Dr. Kaunitz: Due to her high lifetime risk of breast and ovarian cancer, this woman has proceeded with risk-reducing breast and gynecologic surgery. As more BRCA mutation carriers are being identified and undergo risk-reducing bilateral mastectomy (usually with reconstruction) and salpingo-oophorectomy, clinicians and mutation carriers more frequently face decisions regarding use of systemic hormone therapy.

Mutation carriers who have undergone bilateral risk-reducing mastectomy experience a very low baseline future risk for breast cancer; accordingly, concerns regarding this disease should not prevent use of systemic hormone therapy. Furthermore, without hormone replacement, induced menopause in women this age is associated with an elevated risk of osteoporosis, persistent vasomotor symptoms, cardiovascular disease, stroke, mood changes, dementia, Parkinson disease, and overall mortality. Recognizing the safety of estrogen therapy in this setting, this 42-year-old BRCA1 mutation carrier can initiate estrogen therapy. Standard dose estrogen therapy refers to oral estradiol 1.0 mg, conjugated equine estrogen 0.625 mg,or transdermal estradiol 0.05 mg. In younger women like this 42-year-old with surgically induced menopause, higher than standard replacement doses of estrogen are often appropriate.¹⁷

Due to concerns the hormone therapy might further increase future risk of breast cancer, some mutation carriers may delay or avoid risk-reducing bilateral salpingo-oophorectomy, a potentially lifesaving surgery which reduces not only future risk of ovarian cancer but also future risk for breast cancer.

Among mutation carriers with intact breasts, several studies address risk of breast cancer with use of systemic hormone therapy. Although limited in numbers of participants and years of follow-up, in aggregate, these studies provide reassurance that short-term use of systemic hormone therapy does not increase breast cancer risk in women with BRCA1 or BRCA2 mutations and intact breasts.¹⁹

Dr. Pinkerton: For this woman with early surgical menopause and hysterectomy, estrogen therapy could improve her vasomotor symptoms and decrease her risk of bone loss and GSM.¹⁷ In the Women's Health Initiative trial, there were 7 fewer breast cancers per 10,000 women-years in the estrogen-onlyarm.²⁰ Observational studies suggest that hormone therapy, when given to the average age of menopause, decreases the risks of heart disease, Parkinson disease, and dementia.²¹ Limited observational evidence suggests that hormone therapy use does not further increase risk of breast cancer in women following oophorectomy for BRCA1 or BRCA2 gene mutation.²²

The absolute risks observed with hormone therapy tended to be small, especially in younger, healthy women. Systemic hormone therapy could treat her hot flashes and her GSM symptoms and potentially decrease health risks associated with premature estrogen deficiency. Nonestrogen therapies for hot flashes include low-dose antidepressants, gabapentin, and mind-body options, such as cognitive behavioral therapy and hypnosis, but these would not decrease her health risks or treat her GSM.

If she only requests treatment of her GSM symptoms, she would be a candidate for low-dose vaginal estrogen therapy, given as a cream, tablet, or ring depending on her choice. I would not choose ospemifene as my first choice as she is having hot flashes, and there are no data yet on the drug's health benefits in early menopause. If she prefers nonestrogen vaginal therapy, the new intravaginal DHEA might be a good choice as both estrogen and testosterone are increased locally in the vagina while hormone levels remain in the postmenopausal range. There is no boxed warning on the patient insert, although safety in women with breast cancer or in those with elevated risk of breast cancer has not been tested.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

Illustration: Kimberly Martens for OBG Management

Sexual function is a complex, multifaceted process mediated by neurologic functions, hormonal regulation, and psychological factors. What could possibly go wrong?

As it turns out, quite a lot. Female sexual dysfunction is a common, vastly undertreated sexual health problem that can have wide-reaching effects on a woman’s life. These effects may include impaired body image, self-confidence, and self-worth. Sexual dysfunction also can contribute to relationship dissatisfaction and leave one feeling less connected with her partner.^1,2 Studies have shown women with sexual dysfunction have higher health care expenditures³ and that depression and fatigue are common comorbidities, as is frequently seen in other chronic conditions such as diabetes and back pain.⁴

Understanding the pathogenesis of female sexual dysfunction helps to guide our approach to its management. Indeed, increased understanding of its pathology has helped to usher in new and emerging treatment options, as well as a personalized, biopsychosocial approach to its management.

Related article:
2016 Update on female sexual dysfunction

In this Update, I discuss the interplay of physiologic and psychological factors that affect female sexual function as well as the latest options for its management. I have also assembled a panel of experts to discuss 2 cases representative of sexual dysfunction that you may encounter in your clinical practice and how prescribing decisions are made for their management.

Read about factors that impact sexual function and agents to help manage dysfunction.

Multiple transmitters in the brain can increase or decrease sexual desire and function

Neurotransmitters involved in sexual excitation include brain dopamine, melanocortin, oxytocin, vasopressin, and norepinephrine, whereas brain opioids, serotonin, prolactin, and endocannabinoids function as sexual inhibitors. Inhibitory transmitters are activated normally during sexual refractoriness but also from primary aversion or secondary avoidance disorders.¹ Drugs or conditions that reduce brain dopamine levels, increase the action of brain serotonin, or enhance brain opioid pathways have been shown to inhibit sexual desire, while those that increase hypothalamic and mesolimbic dopamine or decrease serotonin release have been shown to stimulate sexual desire.¹ 

Estradiol and progesterone can impact sexual function and desire

In addition to the neurotransmitters, hormones are important modulators of female sexual function. Decreasing levels of circulating estrogen after menopause lead to physiologic, biologic, and clinical changes in the urogenital tissues, such as decreased elastin, thinning of the epithelium, reduced vaginal blood flow, diminished lubrication, and decreased flexibility and elasticity. These changes result in the symptoms of genitourinary syndrome of menopause (GSM), which affects as many as half of all menopausal women.^5,6 In clinical trials, dyspareunia and vaginal dryness are the most bothersome GSM symptoms reported.⁷

The role of hormonal regulation in sexual dysfunction among premenopausal women is not yet fully understood, but we do know that estradiol has been shown to improve sexual desire, progesterone tends to dampen sexual desire, and that testosterone at physiological levels has been shown in most studies to have a neutral effect on sexual desire in a well-estrogenized patient.⁸

Related article:
Focus on treating genital atrophy symptoms

Experience and behavior modulate or reinforce sexual dysfunction

The most common psychological factors that trigger or amplify female sexual dysfunction are depression, anxiety, distraction, negative body image, sexual abuse, and emotional neglect.⁹ Contextual or sociocultural factors, such as relationship discord, life-stage stressors (the empty nest syndrome or anxiety and sleep deprivation from a new baby), as well as cultural or religious values that suppress sexuality, also should be considered.⁹ Experience-based neuroplasticity (changes in brain pathways that become solidified by negative or positive experiences) may elucidate how a multimodal approach, utilizing medical and psychological treatment, can be beneficial for patients, particularly those with hypoactive sexual desire disorder (HSDD).¹

New and emerging approaches to managing female sexual dysfunction

Three agents, one of which has been available for prescription for some time, one that is newly available, and one in the pipeline, are or may soon be in the gynecologist's armamentarium.

Flibanserin

Medications that target excitatory pathways or blunt inhibitory pathways are in development, and one, flibanserin (Addyi), has been US Food and Drug Administration (FDA)-approved for the treatment of acquired, generalized HSDD in premenopausal women.^1,10 Flibanserin is a nonhormonal, centrally acting, postsynaptic serotonin 1A receptor agonist and a serotonin 2A receptor antagonist that is taken daily at bedtime (100 mg); several weeks are usually needed before any effects are noted.¹ It is not approved for postmenopausal women and has a boxed warning about the risks of hypotension and syncope; its use is contraindicated in women who drink alcohol, in those who have hepatic impairment, and with the use of moderate or strong CYP3A4 inhibitors.¹¹

Also keep in mind that flibanserin is only available through a Risk Evaluation and Mitigation Strategy program, so clinicians who wish to prescribe it must enroll in and complete training to become certified providers.⁹

Related article:
What you need to know (and do) to prescribe the new drug flibanserin

Prasterone

Prasterone (Intrarosa), a once-daily intravaginal dehydroepiandrosterone (DHEA) product, is a prohormone that increases local estrogen and testosterone and has the advantage of improved sexual function, desire, arousal, lubrication, orgasm, satisfaction, as well as pain at sexual activity.¹² It was approved by the FDA in November 2016 to treat moderate to severe dyspareunia and has been available for prescribing since July 2017. Its cost is comparable to topical estrogen products, with a $25 copay program.

Because prasterone is not an estrogen, it does not have the boxed warning that all estrogen products are mandated by the FDA to have. This may make it more acceptable to patients, who often decline to use an estrogen product after seeing the boxed warning on the package. The Centers for Medicare and Medicaid Services (CMS) does not have prasterone on its list of potentially hazardous drugs for the elderly. However, keep in mind that because its label is for dyspareunia and not specifically for GSM, CMS considers it a drug of choice--in other words, like sildenafil (Viagra), a lifestyle choice and not for treatment of a medical condition. As such, at the present time, Medicare does not cover it.

Bremelanotide

Late-stage trials of bremelanotide, a melanocortin receptor agonist, are underway. Its mechanism of action is somewhat like that of flibanserin in that both drugs increase dopamine and norepinephrine levels. The advantage of bremelanotide is that it is used as needed. It is dosed subcutaneously (1.75 mg) and it can be used as often as a woman would like to use it. The FDA is expected to consider it for approval in about a year. Unpublished data from poster sessions at recent meetings show that, in a phase 3 study of 1,247 premenopausal women with HSDD (who had already been screened for depression and were found to have a physiologic condition), improvements in desire, arousal, lubrication, and orgasm were shown with bremelanotide. About 18% of women stopped using the drug because of adverse effects (nausea, vomiting, flushing, or headache) versus 2% for placebo. Like flibanserin, it is expected to be approved for premenopausal women only. 

Read how 3 experts would manage differing GSM symptoms.

What would you prescribe for these patients? 

CASE Genitourinary syndrome of menopause (GSM) in a 55-year-old woman

A 55-year-old widow is beginning a new relationship. She has not had partnered sexual activity for several years, but she recently has begun a relationship. She describes pain with attempted penetration with her new partner. Her last menstrual period was 3 years ago and she has experienced very minor menopausal symptoms, which are not bothersome. On examination, the vulva and vagina are pale, with thin epithelium and absent rugae. The tissue lacks elasticity. A virginal speculum is needed to visualize the cervix.

How would you go about deciding which of the many options for management of GSM you will recommend for this patient? What do you weigh as you consider DHEA versus estrogen and topical versus oral therapy?
 
JoAnn V. Pinkerton, MD: Vulvovaginal atrophy (VVA), part of GSM, is associated with postmenopausal estrogen deficiency and includes the signs and symptoms seen on this patient's physical exam: vaginal narrowing, pallor, loss of elasticity, as well as pain with intercourse.⁶ Estrogen therapy is the most effective treatment for vaginal atrophy.¹³ Since she does not have significant menopausal symptoms, low-dose vaginal estrogen preparations are effective and generally safe treatments for VVA; these include creams, tablets containing estradiol or conjugated equine estrogen (CEE), and a low-dose vaginal estradiol ring--all available at doses that result in minimal systemic absorption.

Choice is usually made based on patient desire and likely adherence. If the patient prefers nonestrogen therapies that improve VVA and have been approved for relief of dyspareunia in postmenopausal women, I would discuss with the patient the oral selective estrogen receptor modulator ospemifene,¹⁴ and the new intravaginal DHEA suppositories, prasterone.¹⁵ Ospemifene is taken daily as an oral tablet, has a small risk of blood clots, and is my choice for women who do not need systemic hormone therapy and prefer to avoid vaginal therapy.

Andrew M. Kaunitz, MD: GSM is prevalent in menopausal women and, if not treated, causes progressive vaginal dryness and sexual discomfort. When the main indication for hormonal management in a menopausal woman is GSM (as opposed to treatment of vasomotor symptoms or prevention of osteoporosis), the treatment of choice is low-dose local vaginal estrogen, ospemifene, or prasterone (DHEA). Prasterone is a vaginally administered nonestrogen steroid that was approved by the FDA to treat dyspareunia associated with GSM. DHEA is an endogenous inactive steroid that is converted locally into androgens and estrogens; one vaginal insert is placed nightly.^16,17

This 55-year-old widow has not been sexually active for some time. The facts that attempted penetration was painful and only an ultrathin (virginal) speculum could be used for examination indicate that contraction of the pelvic floor muscles is likely present. Simply starting medical management may not lead to comfortable/successful penetrative sex for this woman. In addition to  medical management, she would likely benefit from referral for physical therapy. Using dilators and other strategies, along with the positive impact that medical management will have on the vaginal mucosa, a woman's physical therapist can work with this patient to help the pelvic floor muscles relax and facilitate comfortable penetrative sex.

James A. Simon, MD: With only minor vasomotor symptoms, I would assess the other potential benefits of a systemic therapy. These might include cardiovascular risk reduction (systemic estrogens or estrogens/progesterone in some), breast cancer risk reduction (some data suggesting ospemifene can accomplish this), osteoporosis prevention (systemic estrogens and estrogen/androgens), etc. If there is an option for a treatment to address more than one symptom, in this case GSM, assessing the risks/benefits of each of these therapies should be estimated for this specific patient.

If there are no systemic benefits to be had, then any of the local treatments should be helpful. As there are no head-to-head comparisons available, local estrogen cream, tablets, rings, local DHEA, or systemic ospemifene each should be considered possible treatments. I also feel this patient may benefit from supplementary self-dilation and/or physical therapy.

Related article:
2017 Update on menopause

 
CASE Dyspareunia and vasomotor symptoms in a 42-year-old breast cancer survivor

A 42-year-old woman with a BRCA1 mutation has undergone prophylactic mastectomies as well as hysterectomy with bilateral salpingo-oophorectomy. She reports mild to moderate hot flashes and bothersome vaginal dryness and dyspareunia. Examination confirms GSM.

Would you advise systemic hormone therapy for this patient? What would your recommendation be for management of her GSM symptoms?

Dr. Simon: While one's gut reaction would be to avoid systemic estrogen therapy in a patient with a BRCA1 mutation, the scientific information confirming this fear is lacking.¹⁸ Such patients may benefit significantly from systemic estrogen therapy (reduced risk of cardiovascular disease and cognitive decline, etc.), and with both breasts and both ovaries removed, estrogen's breast cancer risks, if any in this population, are largely avoided. The patient also may benefit from additional local therapy with either estrogens or DHEA.

Dr. Kaunitz: Due to her high lifetime risk of breast and ovarian cancer, this woman has proceeded with risk-reducing breast and gynecologic surgery. As more BRCA mutation carriers are being identified and undergo risk-reducing bilateral mastectomy (usually with reconstruction) and salpingo-oophorectomy, clinicians and mutation carriers more frequently face decisions regarding use of systemic hormone therapy.

Mutation carriers who have undergone bilateral risk-reducing mastectomy experience a very low baseline future risk for breast cancer; accordingly, concerns regarding this disease should not prevent use of systemic hormone therapy. Furthermore, without hormone replacement, induced menopause in women this age is associated with an elevated risk of osteoporosis, persistent vasomotor symptoms, cardiovascular disease, stroke, mood changes, dementia, Parkinson disease, and overall mortality. Recognizing the safety of estrogen therapy in this setting, this 42-year-old BRCA1 mutation carrier can initiate estrogen therapy. Standard dose estrogen therapy refers to oral estradiol 1.0 mg, conjugated equine estrogen 0.625 mg,or transdermal estradiol 0.05 mg. In younger women like this 42-year-old with surgically induced menopause, higher than standard replacement doses of estrogen are often appropriate.¹⁷

Due to concerns the hormone therapy might further increase future risk of breast cancer, some mutation carriers may delay or avoid risk-reducing bilateral salpingo-oophorectomy, a potentially lifesaving surgery which reduces not only future risk of ovarian cancer but also future risk for breast cancer.

Among mutation carriers with intact breasts, several studies address risk of breast cancer with use of systemic hormone therapy. Although limited in numbers of participants and years of follow-up, in aggregate, these studies provide reassurance that short-term use of systemic hormone therapy does not increase breast cancer risk in women with BRCA1 or BRCA2 mutations and intact breasts.¹⁹

Dr. Pinkerton: For this woman with early surgical menopause and hysterectomy, estrogen therapy could improve her vasomotor symptoms and decrease her risk of bone loss and GSM.¹⁷ In the Women's Health Initiative trial, there were 7 fewer breast cancers per 10,000 women-years in the estrogen-onlyarm.²⁰ Observational studies suggest that hormone therapy, when given to the average age of menopause, decreases the risks of heart disease, Parkinson disease, and dementia.²¹ Limited observational evidence suggests that hormone therapy use does not further increase risk of breast cancer in women following oophorectomy for BRCA1 or BRCA2 gene mutation.²²

The absolute risks observed with hormone therapy tended to be small, especially in younger, healthy women. Systemic hormone therapy could treat her hot flashes and her GSM symptoms and potentially decrease health risks associated with premature estrogen deficiency. Nonestrogen therapies for hot flashes include low-dose antidepressants, gabapentin, and mind-body options, such as cognitive behavioral therapy and hypnosis, but these would not decrease her health risks or treat her GSM.

If she only requests treatment of her GSM symptoms, she would be a candidate for low-dose vaginal estrogen therapy, given as a cream, tablet, or ring depending on her choice. I would not choose ospemifene as my first choice as she is having hot flashes, and there are no data yet on the drug's health benefits in early menopause. If she prefers nonestrogen vaginal therapy, the new intravaginal DHEA might be a good choice as both estrogen and testosterone are increased locally in the vagina while hormone levels remain in the postmenopausal range. There is no boxed warning on the patient insert, although safety in women with breast cancer or in those with elevated risk of breast cancer has not been tested.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

EXPERT COMMENTARY

The American Society for Colposcopy and Cervical Pathology (ASCCP) has recommended HPV triage for ASC-US cytology for more than 15 years. Since the ALTS trial demonstrated improved detection of CIN2+ in women with ASC-US cytology, HPV testing has become the preferred triage strategy for women with ASC-US cytology, except for women under age 25.¹ However, we do not know the long-term outcomes for these women. The study by Cuzick and colleagues uniquely addresses this question.

Details of the study

The retrospective review of data from the New Mexico HPV Pap Registry examined the influence of HPV testing on outcomes in 20,677 women with ASC-US cytology between 2008 and 2012. Of those women, 80.5% had an HPV test, and the authors estimated that 80.6% of those HPV tests were for triage after ASC-US cytology as opposed to co-testing (that is, cytology and HPV testing together). Of note, the majority of these Pap tests were performed prior to the 2012 ASCCP guidelines that recommend HPV co-testing for all women aged 30 to 64 years regardless of cytology. Of the HPV tests performed, 43.1% were positive. The investigators then examined rates of CIN in the interval between ASC-US cytology and biopsy-confirmed CIN, and rates of loop electrosurgical excision procedures (LEEP) and results at 5 years.

The investigators found a non–statistically significant increase in overall detection of CIN3 (relative risk [RR], 1.16; 95% confidence interval [CI], 0.92–1.45) in women who had been triaged with HPV testing, and a significant increase in overall detection of CIN2 (RR, 1.27; 95% CI, 1.06–1.53) and CIN1 (RR, 1.76; 95% CI, 1.56–2.00). CIN1, CIN2, and CIN3 were detected significantly earlier in patients with HPV testing. As expected, the majority of CIN2 and CIN3 was diagnosed in women who were HPV positive.

Related article:
2017 Update on cervical disease

The proportion of women undergoing either endocervical curettage or cervical biopsy was higher in those with HPV testing (32.1% vs 20.6%, P<.001), as were LEEP rates (4.9% vs 4.0%, P = .03). LEEP rates were highest in the year after a positive HPV test and were mostly attributable to CIN1 results. However, the overall ratio of LEEP to CIN3+ diagnosis was similar in women who were tested for HPV compared with those who were not. A larger proportion of patients with HPV testing had follow-up compared with those without HPV testing (84.1% vs 78.9%, P<.001).

The authors concluded that HPV testing in women with ASC-US cytology leads to detecting high-grade disease earlier, but that HPV positivity results in more interventions, largely due to an overdiagnosis of CIN1. They also confirmed that the majority of high-grade lesions are found in women with positive HPV tests.

Related article:
2015 Update on cervical disease: New ammo for HPV prevention and screening

Study strengths and weaknesses

This is the first comprehensive long-term look at women with ASC-US cytology and the impact of HPV testing. The New Mexico HPV Pap Registry is the only US state-based registry with comprehensive follow-up data. This study’s results build on previous data that showed sensitivity is increased with the addition of HPV testing to cervical cytology,¹ and they support current ASCCP guidelines that emphasize HPV triage or co-testing for women age 25 or older.

Potential bias. While this study has the benefit of a large cohort, it is limited by biases inherent in retrospective study design. One important potential bias is the differential utilization of HPV testing or procedures by providers. The authors acknowledge preliminary analyses that show that some clinics (rural, federally qualified health centers, public health clinics) serving underserved populations may underutilize or inappropriately utilize HPV testing.

Further, the 2008–2012 study period may make the results less generalizable to current practices since the ASCCP guidelines were adjusted to include more HPV testing in women aged 25 and older in 2012.

Finally, this study examines CIN but does not specifically look at the impact of HPV testing on the ultimate outcome of interest, cervical cancer rates.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

EXPERT COMMENTARY

The American Society for Colposcopy and Cervical Pathology (ASCCP) has recommended HPV triage for ASC-US cytology for more than 15 years. Since the ALTS trial demonstrated improved detection of CIN2+ in women with ASC-US cytology, HPV testing has become the preferred triage strategy for women with ASC-US cytology, except for women under age 25.¹ However, we do not know the long-term outcomes for these women. The study by Cuzick and colleagues uniquely addresses this question.

Details of the study

The retrospective review of data from the New Mexico HPV Pap Registry examined the influence of HPV testing on outcomes in 20,677 women with ASC-US cytology between 2008 and 2012. Of those women, 80.5% had an HPV test, and the authors estimated that 80.6% of those HPV tests were for triage after ASC-US cytology as opposed to co-testing (that is, cytology and HPV testing together). Of note, the majority of these Pap tests were performed prior to the 2012 ASCCP guidelines that recommend HPV co-testing for all women aged 30 to 64 years regardless of cytology. Of the HPV tests performed, 43.1% were positive. The investigators then examined rates of CIN in the interval between ASC-US cytology and biopsy-confirmed CIN, and rates of loop electrosurgical excision procedures (LEEP) and results at 5 years.

The investigators found a non–statistically significant increase in overall detection of CIN3 (relative risk [RR], 1.16; 95% confidence interval [CI], 0.92–1.45) in women who had been triaged with HPV testing, and a significant increase in overall detection of CIN2 (RR, 1.27; 95% CI, 1.06–1.53) and CIN1 (RR, 1.76; 95% CI, 1.56–2.00). CIN1, CIN2, and CIN3 were detected significantly earlier in patients with HPV testing. As expected, the majority of CIN2 and CIN3 was diagnosed in women who were HPV positive.

Related article:
2017 Update on cervical disease

The proportion of women undergoing either endocervical curettage or cervical biopsy was higher in those with HPV testing (32.1% vs 20.6%, P<.001), as were LEEP rates (4.9% vs 4.0%, P = .03). LEEP rates were highest in the year after a positive HPV test and were mostly attributable to CIN1 results. However, the overall ratio of LEEP to CIN3+ diagnosis was similar in women who were tested for HPV compared with those who were not. A larger proportion of patients with HPV testing had follow-up compared with those without HPV testing (84.1% vs 78.9%, P<.001).

The authors concluded that HPV testing in women with ASC-US cytology leads to detecting high-grade disease earlier, but that HPV positivity results in more interventions, largely due to an overdiagnosis of CIN1. They also confirmed that the majority of high-grade lesions are found in women with positive HPV tests.

Related article:
2015 Update on cervical disease: New ammo for HPV prevention and screening

Study strengths and weaknesses

This is the first comprehensive long-term look at women with ASC-US cytology and the impact of HPV testing. The New Mexico HPV Pap Registry is the only US state-based registry with comprehensive follow-up data. This study’s results build on previous data that showed sensitivity is increased with the addition of HPV testing to cervical cytology,¹ and they support current ASCCP guidelines that emphasize HPV triage or co-testing for women age 25 or older.

Potential bias. While this study has the benefit of a large cohort, it is limited by biases inherent in retrospective study design. One important potential bias is the differential utilization of HPV testing or procedures by providers. The authors acknowledge preliminary analyses that show that some clinics (rural, federally qualified health centers, public health clinics) serving underserved populations may underutilize or inappropriately utilize HPV testing.

Further, the 2008–2012 study period may make the results less generalizable to current practices since the ASCCP guidelines were adjusted to include more HPV testing in women aged 25 and older in 2012.

Finally, this study examines CIN but does not specifically look at the impact of HPV testing on the ultimate outcome of interest, cervical cancer rates.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

EXPERT COMMENTARY

The American Society for Colposcopy and Cervical Pathology (ASCCP) has recommended HPV triage for ASC-US cytology for more than 15 years. Since the ALTS trial demonstrated improved detection of CIN2+ in women with ASC-US cytology, HPV testing has become the preferred triage strategy for women with ASC-US cytology, except for women under age 25.¹ However, we do not know the long-term outcomes for these women. The study by Cuzick and colleagues uniquely addresses this question.

Details of the study

The retrospective review of data from the New Mexico HPV Pap Registry examined the influence of HPV testing on outcomes in 20,677 women with ASC-US cytology between 2008 and 2012. Of those women, 80.5% had an HPV test, and the authors estimated that 80.6% of those HPV tests were for triage after ASC-US cytology as opposed to co-testing (that is, cytology and HPV testing together). Of note, the majority of these Pap tests were performed prior to the 2012 ASCCP guidelines that recommend HPV co-testing for all women aged 30 to 64 years regardless of cytology. Of the HPV tests performed, 43.1% were positive. The investigators then examined rates of CIN in the interval between ASC-US cytology and biopsy-confirmed CIN, and rates of loop electrosurgical excision procedures (LEEP) and results at 5 years.

The investigators found a non–statistically significant increase in overall detection of CIN3 (relative risk [RR], 1.16; 95% confidence interval [CI], 0.92–1.45) in women who had been triaged with HPV testing, and a significant increase in overall detection of CIN2 (RR, 1.27; 95% CI, 1.06–1.53) and CIN1 (RR, 1.76; 95% CI, 1.56–2.00). CIN1, CIN2, and CIN3 were detected significantly earlier in patients with HPV testing. As expected, the majority of CIN2 and CIN3 was diagnosed in women who were HPV positive.

Related article:
2017 Update on cervical disease

The proportion of women undergoing either endocervical curettage or cervical biopsy was higher in those with HPV testing (32.1% vs 20.6%, P<.001), as were LEEP rates (4.9% vs 4.0%, P = .03). LEEP rates were highest in the year after a positive HPV test and were mostly attributable to CIN1 results. However, the overall ratio of LEEP to CIN3+ diagnosis was similar in women who were tested for HPV compared with those who were not. A larger proportion of patients with HPV testing had follow-up compared with those without HPV testing (84.1% vs 78.9%, P<.001).

The authors concluded that HPV testing in women with ASC-US cytology leads to detecting high-grade disease earlier, but that HPV positivity results in more interventions, largely due to an overdiagnosis of CIN1. They also confirmed that the majority of high-grade lesions are found in women with positive HPV tests.

Related article:
2015 Update on cervical disease: New ammo for HPV prevention and screening

Study strengths and weaknesses

This is the first comprehensive long-term look at women with ASC-US cytology and the impact of HPV testing. The New Mexico HPV Pap Registry is the only US state-based registry with comprehensive follow-up data. This study’s results build on previous data that showed sensitivity is increased with the addition of HPV testing to cervical cytology,¹ and they support current ASCCP guidelines that emphasize HPV triage or co-testing for women age 25 or older.

Potential bias. While this study has the benefit of a large cohort, it is limited by biases inherent in retrospective study design. One important potential bias is the differential utilization of HPV testing or procedures by providers. The authors acknowledge preliminary analyses that show that some clinics (rural, federally qualified health centers, public health clinics) serving underserved populations may underutilize or inappropriately utilize HPV testing.

Further, the 2008–2012 study period may make the results less generalizable to current practices since the ASCCP guidelines were adjusted to include more HPV testing in women aged 25 and older in 2012.

Finally, this study examines CIN but does not specifically look at the impact of HPV testing on the ultimate outcome of interest, cervical cancer rates.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

There are no large randomized clinical trials exploring the relationship between COCs and the risk of developing cancer. Many epidemiological studies, however, have investigated the possible association between COC use and the risk of cancer. Such prospective and retrospective studies consistently report that the use of COCs significantly decreases the risk of ovarian and endometrial cancer. The epidemiological data are less consistent concerning the possible association between COC use and the risk of breast cancer. Meta-analyses conclude that current use of COCs may be associated with a small increase in breast cancer risk. In addition, prolonged use of COCs may be associated with an increased risk of cervical cancer.

Ovarian cancer

• 0.78 (0.73–0.83) for 2.4 years
• 0.64 (0.59–0.69) for 6.8 years
• 0.56 (0.50–0.62) for 11.6 years
• 0.42 (0.36–0.49) for 18.3 years.

In the Royal College of General Practitioners Oral Contraceptive (RCGPOC) study, about 23,000 womenwho did not use COCs and 23,000 current users of COCs were recruited around 1968 and followed for a median of 41 years. In this study, current and recent use of COCs was associated with a decreased RR for ovarian cancer (0.49) and the risk reduction persisted for at least 35 years following COC discontinuation (RR, 0.50; 99% CI, 0.29–0.84).²

In the prospective Nurses’ Health Study (NHS) I, 121,700 nurses were recruited in 1976 and followed for more than 30 years.³ For nurses who reported using COCs for more than 5 years, the rate ratio for ovarian cancer at 20 years or less and greater than 20 years since last use was 0.58 (95% CI, 0.61–0.87) and 0.92 (95% CI, 0.61–1.39), respectively. These studies show that the association between COC use and a decreased risk of ovarian cancer persists for many years after discontinuing COCs.

Endometrial cancer

In the RCGPOC study of 46,000 women, the RR of endometrial cancer among current and recent users of COCs was 0.61, and the reduced risk (0.83) persisted for more than 35 years after discontinuing the COC.²

Related article:
2016 Update on cancer: Endometrial cancer

It is thought that the progestin in the COC provides most of the beneficial effect. Progestin-only contraceptives, such as depotmedroxyprogesterone acetate, progestin implants, and levonorgestrel-releasingintrauterine devices (LNG-IUDs) are also thought to reduce endometrial cancer risk. For instance, in a study of 93,842 Finnish women who used the LNG-IUD, the standardized incidence ratio for endometrial cancer was 0.50 among LNG-IUD users compared with the general population.⁵

Read about the effects of COC use in breast and cervical cancer.

Breast cancer

In the prospective NHS study of 116,608 nurses with 1,246,967 years of follow-up, the multivariate relative risk (mRR) of breast cancer with current COC use was 1.33 (95% CI, 1.03–1.73). Past use of COCs was not associated with a significantly increased risk of breast cancer (mRR, 1.12; 95% CI, 0.95–1.33; NS).⁷

In the RCGPOC study (approximately 46,000 women), current use of COCs was associated with an increased risk of breast cancer (incidence rate ratio [IRR], 1.48; 95% CI,1.10–1.97). Five to 15 years after stopping COCs, there was no significant association between prior COC use and breast cancer (IRR, 1.12; 99% CI, 0.91–1.39; NS).²

Related article:
Webcast: Oral contraceptives and breast cancer: What’s the risk?

It is important to note that it is not possible to conclude from these data whether the reported association between current use of COCs and breast cancer is due to early and accelerated diagnosis of breast cancer, the biological effects of hormones contained in COCs on breast tissue and nascent tumors, or both. In addition, formulations of COCs prescribed in the 1960s and 1970s contained higher doses of estrogen, raising the possibility that the association between COCs and breast cancer is due to COC formulations that are no longer prescribed. However, in animal models and postmenopausal women certain combinations of estrogen plus progestin clearly influence breast cancer biology and cancer risk.^8,9

Cervical cancer

• less than 5 years, 0.73 (95% CI, 0.52–1.03)
• 5 to 9 years, 2.82 (95% CI, 1.46–5.42)
• ≥10 years, 4.03 (95% CI, 2.09–8.02).

It is not possible to conclude from these data whether the association between COC use and cervical cancer is due to the biological effects of hormones on the initiation and progression of HPV disease or confounding factors that have yet to be identified. It is known that estrogens and progestins influence the immune defense system of the lower genital tract, and this may be a pathway that influences the acquisition and progression of viral disease.¹² From a clinical perspective, cervical cancer is largely preventable with HPV vaccination and screening. Therefore, the risk between COC use and cervical cancer is likely limited to women who have not been vaccinated and who are not actively participating in cervical cancer screening.

The bottom line

COC use markedly reduces the risk of ovarian and endometrial cancers, and slightly increases the risk of breast cancer. Prolonged COC use may be associated with an increased risk of cervical cancer. Using available epidemiological data, investigators attempted to project the impact of these competing risks on the approximate 12,300,000 females who live in Australia. Based on the pattern of COC use and the cancer incidence in Australia in 2010, the investigators calculated that COC use would cause about 105 breast and 52 cervical cancers and prevent 1,032 endometrial and 308 ovarian cancers.¹³ This analysis indicates that the balance of risks and benefits related to COC use and cancer generally favors COC use.

Prevention of unintended pregnancy is a major public health goal. Many women choose COCs as their preferred approach to preventing unintended pregnancy. Evaluated from a whole-life perspective the health benefits of COCs are substantial and represent a great advance in women’s health.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

There are no large randomized clinical trials exploring the relationship between COCs and the risk of developing cancer. Many epidemiological studies, however, have investigated the possible association between COC use and the risk of cancer. Such prospective and retrospective studies consistently report that the use of COCs significantly decreases the risk of ovarian and endometrial cancer. The epidemiological data are less consistent concerning the possible association between COC use and the risk of breast cancer. Meta-analyses conclude that current use of COCs may be associated with a small increase in breast cancer risk. In addition, prolonged use of COCs may be associated with an increased risk of cervical cancer.

Ovarian cancer

• 0.78 (0.73–0.83) for 2.4 years
• 0.64 (0.59–0.69) for 6.8 years
• 0.56 (0.50–0.62) for 11.6 years
• 0.42 (0.36–0.49) for 18.3 years.

In the Royal College of General Practitioners Oral Contraceptive (RCGPOC) study, about 23,000 womenwho did not use COCs and 23,000 current users of COCs were recruited around 1968 and followed for a median of 41 years. In this study, current and recent use of COCs was associated with a decreased RR for ovarian cancer (0.49) and the risk reduction persisted for at least 35 years following COC discontinuation (RR, 0.50; 99% CI, 0.29–0.84).²

In the prospective Nurses’ Health Study (NHS) I, 121,700 nurses were recruited in 1976 and followed for more than 30 years.³ For nurses who reported using COCs for more than 5 years, the rate ratio for ovarian cancer at 20 years or less and greater than 20 years since last use was 0.58 (95% CI, 0.61–0.87) and 0.92 (95% CI, 0.61–1.39), respectively. These studies show that the association between COC use and a decreased risk of ovarian cancer persists for many years after discontinuing COCs.

Endometrial cancer

In the RCGPOC study of 46,000 women, the RR of endometrial cancer among current and recent users of COCs was 0.61, and the reduced risk (0.83) persisted for more than 35 years after discontinuing the COC.²

Related article:
2016 Update on cancer: Endometrial cancer

It is thought that the progestin in the COC provides most of the beneficial effect. Progestin-only contraceptives, such as depotmedroxyprogesterone acetate, progestin implants, and levonorgestrel-releasingintrauterine devices (LNG-IUDs) are also thought to reduce endometrial cancer risk. For instance, in a study of 93,842 Finnish women who used the LNG-IUD, the standardized incidence ratio for endometrial cancer was 0.50 among LNG-IUD users compared with the general population.⁵

Read about the effects of COC use in breast and cervical cancer.

Breast cancer

In the prospective NHS study of 116,608 nurses with 1,246,967 years of follow-up, the multivariate relative risk (mRR) of breast cancer with current COC use was 1.33 (95% CI, 1.03–1.73). Past use of COCs was not associated with a significantly increased risk of breast cancer (mRR, 1.12; 95% CI, 0.95–1.33; NS).⁷

In the RCGPOC study (approximately 46,000 women), current use of COCs was associated with an increased risk of breast cancer (incidence rate ratio [IRR], 1.48; 95% CI,1.10–1.97). Five to 15 years after stopping COCs, there was no significant association between prior COC use and breast cancer (IRR, 1.12; 99% CI, 0.91–1.39; NS).²

Related article:
Webcast: Oral contraceptives and breast cancer: What’s the risk?

It is important to note that it is not possible to conclude from these data whether the reported association between current use of COCs and breast cancer is due to early and accelerated diagnosis of breast cancer, the biological effects of hormones contained in COCs on breast tissue and nascent tumors, or both. In addition, formulations of COCs prescribed in the 1960s and 1970s contained higher doses of estrogen, raising the possibility that the association between COCs and breast cancer is due to COC formulations that are no longer prescribed. However, in animal models and postmenopausal women certain combinations of estrogen plus progestin clearly influence breast cancer biology and cancer risk.^8,9

Cervical cancer

• less than 5 years, 0.73 (95% CI, 0.52–1.03)
• 5 to 9 years, 2.82 (95% CI, 1.46–5.42)
• ≥10 years, 4.03 (95% CI, 2.09–8.02).

It is not possible to conclude from these data whether the association between COC use and cervical cancer is due to the biological effects of hormones on the initiation and progression of HPV disease or confounding factors that have yet to be identified. It is known that estrogens and progestins influence the immune defense system of the lower genital tract, and this may be a pathway that influences the acquisition and progression of viral disease.¹² From a clinical perspective, cervical cancer is largely preventable with HPV vaccination and screening. Therefore, the risk between COC use and cervical cancer is likely limited to women who have not been vaccinated and who are not actively participating in cervical cancer screening.

The bottom line

COC use markedly reduces the risk of ovarian and endometrial cancers, and slightly increases the risk of breast cancer. Prolonged COC use may be associated with an increased risk of cervical cancer. Using available epidemiological data, investigators attempted to project the impact of these competing risks on the approximate 12,300,000 females who live in Australia. Based on the pattern of COC use and the cancer incidence in Australia in 2010, the investigators calculated that COC use would cause about 105 breast and 52 cervical cancers and prevent 1,032 endometrial and 308 ovarian cancers.¹³ This analysis indicates that the balance of risks and benefits related to COC use and cancer generally favors COC use.

Prevention of unintended pregnancy is a major public health goal. Many women choose COCs as their preferred approach to preventing unintended pregnancy. Evaluated from a whole-life perspective the health benefits of COCs are substantial and represent a great advance in women’s health.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

There are no large randomized clinical trials exploring the relationship between COCs and the risk of developing cancer. Many epidemiological studies, however, have investigated the possible association between COC use and the risk of cancer. Such prospective and retrospective studies consistently report that the use of COCs significantly decreases the risk of ovarian and endometrial cancer. The epidemiological data are less consistent concerning the possible association between COC use and the risk of breast cancer. Meta-analyses conclude that current use of COCs may be associated with a small increase in breast cancer risk. In addition, prolonged use of COCs may be associated with an increased risk of cervical cancer.

Ovarian cancer

• 0.78 (0.73–0.83) for 2.4 years
• 0.64 (0.59–0.69) for 6.8 years
• 0.56 (0.50–0.62) for 11.6 years
• 0.42 (0.36–0.49) for 18.3 years.

In the Royal College of General Practitioners Oral Contraceptive (RCGPOC) study, about 23,000 womenwho did not use COCs and 23,000 current users of COCs were recruited around 1968 and followed for a median of 41 years. In this study, current and recent use of COCs was associated with a decreased RR for ovarian cancer (0.49) and the risk reduction persisted for at least 35 years following COC discontinuation (RR, 0.50; 99% CI, 0.29–0.84).²

In the prospective Nurses’ Health Study (NHS) I, 121,700 nurses were recruited in 1976 and followed for more than 30 years.³ For nurses who reported using COCs for more than 5 years, the rate ratio for ovarian cancer at 20 years or less and greater than 20 years since last use was 0.58 (95% CI, 0.61–0.87) and 0.92 (95% CI, 0.61–1.39), respectively. These studies show that the association between COC use and a decreased risk of ovarian cancer persists for many years after discontinuing COCs.

Endometrial cancer

In the RCGPOC study of 46,000 women, the RR of endometrial cancer among current and recent users of COCs was 0.61, and the reduced risk (0.83) persisted for more than 35 years after discontinuing the COC.²

Related article:
2016 Update on cancer: Endometrial cancer

It is thought that the progestin in the COC provides most of the beneficial effect. Progestin-only contraceptives, such as depotmedroxyprogesterone acetate, progestin implants, and levonorgestrel-releasingintrauterine devices (LNG-IUDs) are also thought to reduce endometrial cancer risk. For instance, in a study of 93,842 Finnish women who used the LNG-IUD, the standardized incidence ratio for endometrial cancer was 0.50 among LNG-IUD users compared with the general population.⁵

Read about the effects of COC use in breast and cervical cancer.

Breast cancer

In the prospective NHS study of 116,608 nurses with 1,246,967 years of follow-up, the multivariate relative risk (mRR) of breast cancer with current COC use was 1.33 (95% CI, 1.03–1.73). Past use of COCs was not associated with a significantly increased risk of breast cancer (mRR, 1.12; 95% CI, 0.95–1.33; NS).⁷

In the RCGPOC study (approximately 46,000 women), current use of COCs was associated with an increased risk of breast cancer (incidence rate ratio [IRR], 1.48; 95% CI,1.10–1.97). Five to 15 years after stopping COCs, there was no significant association between prior COC use and breast cancer (IRR, 1.12; 99% CI, 0.91–1.39; NS).²

Related article:
Webcast: Oral contraceptives and breast cancer: What’s the risk?

It is important to note that it is not possible to conclude from these data whether the reported association between current use of COCs and breast cancer is due to early and accelerated diagnosis of breast cancer, the biological effects of hormones contained in COCs on breast tissue and nascent tumors, or both. In addition, formulations of COCs prescribed in the 1960s and 1970s contained higher doses of estrogen, raising the possibility that the association between COCs and breast cancer is due to COC formulations that are no longer prescribed. However, in animal models and postmenopausal women certain combinations of estrogen plus progestin clearly influence breast cancer biology and cancer risk.^8,9

Cervical cancer

• less than 5 years, 0.73 (95% CI, 0.52–1.03)
• 5 to 9 years, 2.82 (95% CI, 1.46–5.42)
• ≥10 years, 4.03 (95% CI, 2.09–8.02).

It is not possible to conclude from these data whether the association between COC use and cervical cancer is due to the biological effects of hormones on the initiation and progression of HPV disease or confounding factors that have yet to be identified. It is known that estrogens and progestins influence the immune defense system of the lower genital tract, and this may be a pathway that influences the acquisition and progression of viral disease.¹² From a clinical perspective, cervical cancer is largely preventable with HPV vaccination and screening. Therefore, the risk between COC use and cervical cancer is likely limited to women who have not been vaccinated and who are not actively participating in cervical cancer screening.

The bottom line

COC use markedly reduces the risk of ovarian and endometrial cancers, and slightly increases the risk of breast cancer. Prolonged COC use may be associated with an increased risk of cervical cancer. Using available epidemiological data, investigators attempted to project the impact of these competing risks on the approximate 12,300,000 females who live in Australia. Based on the pattern of COC use and the cancer incidence in Australia in 2010, the investigators calculated that COC use would cause about 105 breast and 52 cervical cancers and prevent 1,032 endometrial and 308 ovarian cancers.¹³ This analysis indicates that the balance of risks and benefits related to COC use and cancer generally favors COC use.

Prevention of unintended pregnancy is a major public health goal. Many women choose COCs as their preferred approach to preventing unintended pregnancy. Evaluated from a whole-life perspective the health benefits of COCs are substantial and represent a great advance in women’s health.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

“THE PELVIC EXAM REVISITED”
ERIN HIGGINS, MD, AND
CHERYL B. IGLESIA, MD (AUGUST 2017)

Pelvic examination is essential to clinical care

I have contemplated the issue of the routine screening pelvic exam now for several years. But for the last year, I have found various problems in many “asymptomatic women.” For example: The 18-year-old who was “not sexually active” but who had Chlamydia. Or the 84-year-old who denied itching or other vulvovaginal symptoms who had either vulvar cancer or lichen sclerosis so severe her vagina was almost closed; a 30-minute review of her outside records revealed recurrent urinary tract infections requiring more than 5 courses of antibiotics in 6 months for what was actually contaminants from a urine specimen that passed through the vagina first. I think the move away from actually touching patients has completely gotten out of hand! It is appalling how many women I have seen who visited an emergency department for pelvic or abdominal pain and never had a hands-on examination. If we do not examine the part of the body that many completely ignore we may as well lose our specialty!

Christine Kneer-Aronoff, MD
Cincinnati, Ohio

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

“THE PELVIC EXAM REVISITED”
ERIN HIGGINS, MD, AND
CHERYL B. IGLESIA, MD (AUGUST 2017)

Pelvic examination is essential to clinical care

I have contemplated the issue of the routine screening pelvic exam now for several years. But for the last year, I have found various problems in many “asymptomatic women.” For example: The 18-year-old who was “not sexually active” but who had Chlamydia. Or the 84-year-old who denied itching or other vulvovaginal symptoms who had either vulvar cancer or lichen sclerosis so severe her vagina was almost closed; a 30-minute review of her outside records revealed recurrent urinary tract infections requiring more than 5 courses of antibiotics in 6 months for what was actually contaminants from a urine specimen that passed through the vagina first. I think the move away from actually touching patients has completely gotten out of hand! It is appalling how many women I have seen who visited an emergency department for pelvic or abdominal pain and never had a hands-on examination. If we do not examine the part of the body that many completely ignore we may as well lose our specialty!

Christine Kneer-Aronoff, MD
Cincinnati, Ohio

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

“THE PELVIC EXAM REVISITED”
ERIN HIGGINS, MD, AND
CHERYL B. IGLESIA, MD (AUGUST 2017)

Pelvic examination is essential to clinical care

I have contemplated the issue of the routine screening pelvic exam now for several years. But for the last year, I have found various problems in many “asymptomatic women.” For example: The 18-year-old who was “not sexually active” but who had Chlamydia. Or the 84-year-old who denied itching or other vulvovaginal symptoms who had either vulvar cancer or lichen sclerosis so severe her vagina was almost closed; a 30-minute review of her outside records revealed recurrent urinary tract infections requiring more than 5 courses of antibiotics in 6 months for what was actually contaminants from a urine specimen that passed through the vagina first. I think the move away from actually touching patients has completely gotten out of hand! It is appalling how many women I have seen who visited an emergency department for pelvic or abdominal pain and never had a hands-on examination. If we do not examine the part of the body that many completely ignore we may as well lose our specialty!

Christine Kneer-Aronoff, MD
Cincinnati, Ohio

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

“EFFECTIVE TREATMENT OF RECURRENT BACTERIAL VAGINOSIS”
ROBERT L. BARBIERI, MD (EDITORIAL; JULY 2017)

Appreciates treatment options for recurrent BV

I thank Dr. Barbieri for his editorial on effective treatment of recurrent bacterial vaginosis (BV). I practice only outpatient gynecology, and recurrent BV is the most frustrating condition I have to deal with. Now I have 3 treatment options in my armamentarium for taking care of patients. I clipped the article pages from OBG Management and am keeping them available for easy access when needed.

I have a related question: I see trichomonal vaginitis rarely, maybe 1 to 2 cases in a year. What do you think the reason is?

Vimal Goyle, MD
New York, New York

Beyond BV: Candidiasis and diabetes medications

Thank you for addressing the recurrent BV problem. After many years of throwing antibiotics at this problem I have been underwhelmed. Patients do not want to keep chasing their tails between BV and yeast. I have been suggesting that patients place plain yogurt containing Lactobacillus in a tampon applicator and apply it to the vagina weekly at night, after the original “overgrowth” has been treated, to return the “good bacteria” to the vagina. This avoids overuse of antibiotics (an impending epidemic of resistant organisms), boric acid (a dangerous pill to have around toddlers), and the expense that comes with multiple visits and multiple courses of antibiotics. I believe that in Canada a vaginal ovule with vitamin C and probiotics is available (something to ponder).

Another problem is recurrent yeast infections. We are seeing that many new diabetes medications are increasing the clearance of glucose and are causing severe and intractable Candida vulvovaginitis. In addition, I would like to know the best topical treatments and skin care for yeast in the folds of the panniculus in the morbidly obese. Unfortunately, these patients often have poor or no insurance and therefore cannot afford the cost of many effective remedies.

John Lewis, MD
Bedford, Massachusetts

Another treatment protocol for BV

For recurrent BV, I treat with standard metronidazole 500 mg orally twice daily for 7 days, then immediately start boric acid suppositories for 3 days in a row followed by 1 weekly for 6 weeks, and that usually takes care of it. However, a few caveats: I instruct patients to keep a supply of boric acid suppositories on hand, and if they start to experience symptoms again, to repeat the 3-day, then weekly-for-6 weeks regimen, so essentially they can manage a recurrence themselves.

For patients who come in thinking they have a recurrent yeast infection or BV, which was initially treated elsewhere, I culture for Mycoplasma and Ureaplasma. I often find that one of those organisms is responsible for the infection, requiring completely different treatment.

I also frequently check the vaginal pH, because patients like to see a visual on what I am talking about.

Rebecca Levy-Gantt, DO
Napa, California

Clindamycin appears superior for BV recurrence prevention

In my practice for the past number of years I have been treating BV with clindamycin vaginal cream instead of metronidazole. I have found that the number of women returning with recurrent BV has dropped dramatically. Furthermore, since switching medications, I cannot recall the last time someone required a maintenance dosing regimen. Although anecdotal, the difference between metronidazole and clindamycin treatment seems striking to me.

Daniel N. Sacks, MD
West Palm Beach, Florida

Uses BV regimens in stepwise fashion

To answer Dr. Barbieri’s instant poll question, my preference for treating BV is to start off with Regimen 1 (metronidazole treatment followed by twice weekly vaginal metronidazole for 6 months), as described in his editorial. If problem reports resolve but recur at a later date, then I use Regimen 2 (metronidazole treatment plus 21 days of boric acid vaginal capsules followed by twice weekly vaginal metronidazole for 6 months). I am aware of Regimen 3 (single-dose oral metronidazole plus fluconazole followed by once-monthly metronidazole and fluconazole) but rarely use it.

Carole W. Campbell, DNP, CNM
Gadsden, Alabama

“EFFECTIVE TREATMENT OF RECURRENT BACTERIAL VAGINOSIS”
ROBERT L. BARBIERI, MD (EDITORIAL; JULY 2017)

Appreciates treatment options for recurrent BV

I thank Dr. Barbieri for his editorial on effective treatment of recurrent bacterial vaginosis (BV). I practice only outpatient gynecology, and recurrent BV is the most frustrating condition I have to deal with. Now I have 3 treatment options in my armamentarium for taking care of patients. I clipped the article pages from OBG Management and am keeping them available for easy access when needed.

I have a related question: I see trichomonal vaginitis rarely, maybe 1 to 2 cases in a year. What do you think the reason is?

Vimal Goyle, MD
New York, New York

Beyond BV: Candidiasis and diabetes medications

Thank you for addressing the recurrent BV problem. After many years of throwing antibiotics at this problem I have been underwhelmed. Patients do not want to keep chasing their tails between BV and yeast. I have been suggesting that patients place plain yogurt containing Lactobacillus in a tampon applicator and apply it to the vagina weekly at night, after the original “overgrowth” has been treated, to return the “good bacteria” to the vagina. This avoids overuse of antibiotics (an impending epidemic of resistant organisms), boric acid (a dangerous pill to have around toddlers), and the expense that comes with multiple visits and multiple courses of antibiotics. I believe that in Canada a vaginal ovule with vitamin C and probiotics is available (something to ponder).

Another problem is recurrent yeast infections. We are seeing that many new diabetes medications are increasing the clearance of glucose and are causing severe and intractable Candida vulvovaginitis. In addition, I would like to know the best topical treatments and skin care for yeast in the folds of the panniculus in the morbidly obese. Unfortunately, these patients often have poor or no insurance and therefore cannot afford the cost of many effective remedies.

John Lewis, MD
Bedford, Massachusetts

Another treatment protocol for BV

For recurrent BV, I treat with standard metronidazole 500 mg orally twice daily for 7 days, then immediately start boric acid suppositories for 3 days in a row followed by 1 weekly for 6 weeks, and that usually takes care of it. However, a few caveats: I instruct patients to keep a supply of boric acid suppositories on hand, and if they start to experience symptoms again, to repeat the 3-day, then weekly-for-6 weeks regimen, so essentially they can manage a recurrence themselves.

For patients who come in thinking they have a recurrent yeast infection or BV, which was initially treated elsewhere, I culture for Mycoplasma and Ureaplasma. I often find that one of those organisms is responsible for the infection, requiring completely different treatment.

I also frequently check the vaginal pH, because patients like to see a visual on what I am talking about.

Rebecca Levy-Gantt, DO
Napa, California

Clindamycin appears superior for BV recurrence prevention

In my practice for the past number of years I have been treating BV with clindamycin vaginal cream instead of metronidazole. I have found that the number of women returning with recurrent BV has dropped dramatically. Furthermore, since switching medications, I cannot recall the last time someone required a maintenance dosing regimen. Although anecdotal, the difference between metronidazole and clindamycin treatment seems striking to me.

Daniel N. Sacks, MD
West Palm Beach, Florida

Uses BV regimens in stepwise fashion

To answer Dr. Barbieri’s instant poll question, my preference for treating BV is to start off with Regimen 1 (metronidazole treatment followed by twice weekly vaginal metronidazole for 6 months), as described in his editorial. If problem reports resolve but recur at a later date, then I use Regimen 2 (metronidazole treatment plus 21 days of boric acid vaginal capsules followed by twice weekly vaginal metronidazole for 6 months). I am aware of Regimen 3 (single-dose oral metronidazole plus fluconazole followed by once-monthly metronidazole and fluconazole) but rarely use it.

Carole W. Campbell, DNP, CNM
Gadsden, Alabama

“EFFECTIVE TREATMENT OF RECURRENT BACTERIAL VAGINOSIS”
ROBERT L. BARBIERI, MD (EDITORIAL; JULY 2017)

Appreciates treatment options for recurrent BV

I thank Dr. Barbieri for his editorial on effective treatment of recurrent bacterial vaginosis (BV). I practice only outpatient gynecology, and recurrent BV is the most frustrating condition I have to deal with. Now I have 3 treatment options in my armamentarium for taking care of patients. I clipped the article pages from OBG Management and am keeping them available for easy access when needed.

I have a related question: I see trichomonal vaginitis rarely, maybe 1 to 2 cases in a year. What do you think the reason is?

Vimal Goyle, MD
New York, New York

Beyond BV: Candidiasis and diabetes medications

Thank you for addressing the recurrent BV problem. After many years of throwing antibiotics at this problem I have been underwhelmed. Patients do not want to keep chasing their tails between BV and yeast. I have been suggesting that patients place plain yogurt containing Lactobacillus in a tampon applicator and apply it to the vagina weekly at night, after the original “overgrowth” has been treated, to return the “good bacteria” to the vagina. This avoids overuse of antibiotics (an impending epidemic of resistant organisms), boric acid (a dangerous pill to have around toddlers), and the expense that comes with multiple visits and multiple courses of antibiotics. I believe that in Canada a vaginal ovule with vitamin C and probiotics is available (something to ponder).

Another problem is recurrent yeast infections. We are seeing that many new diabetes medications are increasing the clearance of glucose and are causing severe and intractable Candida vulvovaginitis. In addition, I would like to know the best topical treatments and skin care for yeast in the folds of the panniculus in the morbidly obese. Unfortunately, these patients often have poor or no insurance and therefore cannot afford the cost of many effective remedies.

John Lewis, MD
Bedford, Massachusetts

Another treatment protocol for BV

For recurrent BV, I treat with standard metronidazole 500 mg orally twice daily for 7 days, then immediately start boric acid suppositories for 3 days in a row followed by 1 weekly for 6 weeks, and that usually takes care of it. However, a few caveats: I instruct patients to keep a supply of boric acid suppositories on hand, and if they start to experience symptoms again, to repeat the 3-day, then weekly-for-6 weeks regimen, so essentially they can manage a recurrence themselves.

For patients who come in thinking they have a recurrent yeast infection or BV, which was initially treated elsewhere, I culture for Mycoplasma and Ureaplasma. I often find that one of those organisms is responsible for the infection, requiring completely different treatment.

I also frequently check the vaginal pH, because patients like to see a visual on what I am talking about.

Rebecca Levy-Gantt, DO
Napa, California

Clindamycin appears superior for BV recurrence prevention

In my practice for the past number of years I have been treating BV with clindamycin vaginal cream instead of metronidazole. I have found that the number of women returning with recurrent BV has dropped dramatically. Furthermore, since switching medications, I cannot recall the last time someone required a maintenance dosing regimen. Although anecdotal, the difference between metronidazole and clindamycin treatment seems striking to me.

Daniel N. Sacks, MD
West Palm Beach, Florida

Uses BV regimens in stepwise fashion

To answer Dr. Barbieri’s instant poll question, my preference for treating BV is to start off with Regimen 1 (metronidazole treatment followed by twice weekly vaginal metronidazole for 6 months), as described in his editorial. If problem reports resolve but recur at a later date, then I use Regimen 2 (metronidazole treatment plus 21 days of boric acid vaginal capsules followed by twice weekly vaginal metronidazole for 6 months). I am aware of Regimen 3 (single-dose oral metronidazole plus fluconazole followed by once-monthly metronidazole and fluconazole) but rarely use it.

Carole W. Campbell, DNP, CNM
Gadsden, Alabama

“CARING FOR THE TRANSGENDER PATIENT: THE ROLE OF THE GYNECOLOGIST”
CECILE A. UNGER, MD, MPH (JUNE 2017)

Calls for respect for transgender patients

We must keep in mind that transgender males are still sexually anatomically female, with all of the medical needs of any other female. Transgender is merely a social construct. We must treat them with kindness and respect.

Laurence Burns, DO
Grand Rapids, Michigan

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

“CARING FOR THE TRANSGENDER PATIENT: THE ROLE OF THE GYNECOLOGIST”
CECILE A. UNGER, MD, MPH (JUNE 2017)

Calls for respect for transgender patients

We must keep in mind that transgender males are still sexually anatomically female, with all of the medical needs of any other female. Transgender is merely a social construct. We must treat them with kindness and respect.

Laurence Burns, DO
Grand Rapids, Michigan

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

“CARING FOR THE TRANSGENDER PATIENT: THE ROLE OF THE GYNECOLOGIST”
CECILE A. UNGER, MD, MPH (JUNE 2017)

Calls for respect for transgender patients

We must keep in mind that transgender males are still sexually anatomically female, with all of the medical needs of any other female. Transgender is merely a social construct. We must treat them with kindness and respect.

Laurence Burns, DO
Grand Rapids, Michigan

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

Suture found in bladder after hysterectomy

A 40-year-old woman underwent a hysterectomy due to dysmenorrhea. Despite the presence of blood in the catheter bag after the procedure, the surgeon did not consult a urologist or perform a cystoscopy. Later, when the patient reported urinary retention, urinary leakage, and dyspareunia, a urologist performed a cystoscopy and discovered a suture in the bladder wall and a vesicovaginal fistula.

PATIENTS' CLAIM:

During the procedure, the gynecologic surgeon inadvertently placed a suture in the bladder wall. The presence of blood in the Foley catheter required an immediate urology consult and cystoscopy, during which the presence of the errant suture would have been discovered. Repair surgery then would have prevented subsequent injuries.

PHYSICIANS' DEFENSE:

The surgeon used reasonable judgment, as there were explanations for the blood in the catheter due to a difficult catheter placement and lysis of bladder adhesions.

VERDICT:

A Michigan defense verdict was returned.

Related article:
How to avoid intestinal and urinary tract injuries during gynecologic laparoscopy

Bowel injury during tubal ligation

A 40-year-old woman underwent laparoscopic tubal ligation using cauterization at an outpatient surgery center. Two hours after the procedure, her BP began to drop. She was promptly transferred to a hospital and underwent emergency surgery that revealed a bowel injury. Part of the patient’s small intestine was resected.

PATIENTS' CLAIM:

The gynecologic surgeon committed a medical error when she injured the bowel during trocar insertion.

DEFENDANTS' DEFENSE:

The bowel injury was a known complication of the surgery.

VERDICT:

A Louisiana defense verdict was returned.

Related article:
How to avoid major vessel injury during gynecologic laparoscopy

Colon injured twice: $1M settlement

A 59-year-old woman underwent laparoscopic total hysterectomy and salpingectomy. Her history included an umbilical hernia repair.

Two days after surgery, the patient experienced abdominal pain, chills, abdominal distention, and a foul-smelling discharge from her umbilical suture site. She went to the emergency department where a computed tomography scan revealed 2 injuries in the bowel. Emergency laparotomy included transverse colon resection and right colon colostomy with Hartmann’s pouch. She wore an ostomy bag for 8 months. She developed an infection because of the colostomy and also required operations to resolve a bowel obstruction and repair incisional hernias.

PATIENTS' CLAIM:

The gynecologic surgeon was negligent when performing the surgery. When he inserted the Veress needle and trocar through the patient’s umbilicus, the transverse colon was injured twice with a 3-cm anterior tear and a 1-cm posterior laceration. The injuries were not discovered during the procedure. He should have been more careful knowing that she had undergone prior umbilical hernia surgery.

PHYSICIANS' DEFENSE:

The case was settled before the trial began.

VERDICT:

A $1 million Virginia settlement was reached.

Chronic pain after sling procedure: $2M verdict

A 63-year-old woman reported urinary incontinence to her gynecologist, who performed a transobturator midurethral sling procedure. After surgery, the patient experienced pelvic pain, urinary urgency, intermittent incontinence, and dyspareunia. She returned to the gynecologist twice. He performed a cystoscopy after the second visit but found nothing wrong.

The patient sought a second opinion. A gynecologic surgeon found a large mass in the patient’s bladder consisting of a crystallized piece of tape that had been used to secure the sling supporting the bladder. The mass was removed and the patient reported that, although surgery alleviated many symptoms, she was not pain-free.

PATIENTS' CLAIM:

The gynecologist negligently inserted the end of the sling through one wall of her bladder and failed to detect the malpositioning during surgery or later. He failed to diagnose and treat bladder stones that resulted from the sling’s malpositioning. He failed to perform a cystoscopy when she first reported symptoms and improperly performed cystoscopy at the second visit.

DEFENDANTS' DEFENSE:

There was no negligence on the part of the gynecologist. The patient did not report ongoing symptoms until 1 year after sling insertion.

VERDICT:

A $2 million Pennsylvania verdict was returned.

These cases were selected by the editors of OBG Management from Medical Malpractice Verdicts, Settlements & Experts, with permission of the editor, Lewis Laska (www.verdictslaska.com). The information available to the editors about the cases presented here is sometimes incomplete. Moreover, the cases may or may not have merit. Nevertheless, these cases represent the types of clinical situations that typically result in litigation and are meant to illustrate nationwide variation in jury verdicts and awards.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

Suture found in bladder after hysterectomy

A 40-year-old woman underwent a hysterectomy due to dysmenorrhea. Despite the presence of blood in the catheter bag after the procedure, the surgeon did not consult a urologist or perform a cystoscopy. Later, when the patient reported urinary retention, urinary leakage, and dyspareunia, a urologist performed a cystoscopy and discovered a suture in the bladder wall and a vesicovaginal fistula.

PATIENTS' CLAIM:

During the procedure, the gynecologic surgeon inadvertently placed a suture in the bladder wall. The presence of blood in the Foley catheter required an immediate urology consult and cystoscopy, during which the presence of the errant suture would have been discovered. Repair surgery then would have prevented subsequent injuries.

PHYSICIANS' DEFENSE:

The surgeon used reasonable judgment, as there were explanations for the blood in the catheter due to a difficult catheter placement and lysis of bladder adhesions.

VERDICT:

A Michigan defense verdict was returned.

Related article:
How to avoid intestinal and urinary tract injuries during gynecologic laparoscopy

Bowel injury during tubal ligation

A 40-year-old woman underwent laparoscopic tubal ligation using cauterization at an outpatient surgery center. Two hours after the procedure, her BP began to drop. She was promptly transferred to a hospital and underwent emergency surgery that revealed a bowel injury. Part of the patient’s small intestine was resected.

PATIENTS' CLAIM:

The gynecologic surgeon committed a medical error when she injured the bowel during trocar insertion.

DEFENDANTS' DEFENSE:

The bowel injury was a known complication of the surgery.

VERDICT:

A Louisiana defense verdict was returned.

Related article:
How to avoid major vessel injury during gynecologic laparoscopy

Colon injured twice: $1M settlement

A 59-year-old woman underwent laparoscopic total hysterectomy and salpingectomy. Her history included an umbilical hernia repair.

Two days after surgery, the patient experienced abdominal pain, chills, abdominal distention, and a foul-smelling discharge from her umbilical suture site. She went to the emergency department where a computed tomography scan revealed 2 injuries in the bowel. Emergency laparotomy included transverse colon resection and right colon colostomy with Hartmann’s pouch. She wore an ostomy bag for 8 months. She developed an infection because of the colostomy and also required operations to resolve a bowel obstruction and repair incisional hernias.

PATIENTS' CLAIM:

The gynecologic surgeon was negligent when performing the surgery. When he inserted the Veress needle and trocar through the patient’s umbilicus, the transverse colon was injured twice with a 3-cm anterior tear and a 1-cm posterior laceration. The injuries were not discovered during the procedure. He should have been more careful knowing that she had undergone prior umbilical hernia surgery.

PHYSICIANS' DEFENSE:

The case was settled before the trial began.

VERDICT:

A $1 million Virginia settlement was reached.

Chronic pain after sling procedure: $2M verdict

A 63-year-old woman reported urinary incontinence to her gynecologist, who performed a transobturator midurethral sling procedure. After surgery, the patient experienced pelvic pain, urinary urgency, intermittent incontinence, and dyspareunia. She returned to the gynecologist twice. He performed a cystoscopy after the second visit but found nothing wrong.

The patient sought a second opinion. A gynecologic surgeon found a large mass in the patient’s bladder consisting of a crystallized piece of tape that had been used to secure the sling supporting the bladder. The mass was removed and the patient reported that, although surgery alleviated many symptoms, she was not pain-free.

PATIENTS' CLAIM:

The gynecologist negligently inserted the end of the sling through one wall of her bladder and failed to detect the malpositioning during surgery or later. He failed to diagnose and treat bladder stones that resulted from the sling’s malpositioning. He failed to perform a cystoscopy when she first reported symptoms and improperly performed cystoscopy at the second visit.

DEFENDANTS' DEFENSE:

There was no negligence on the part of the gynecologist. The patient did not report ongoing symptoms until 1 year after sling insertion.

VERDICT:

A $2 million Pennsylvania verdict was returned.

These cases were selected by the editors of OBG Management from Medical Malpractice Verdicts, Settlements & Experts, with permission of the editor, Lewis Laska (www.verdictslaska.com). The information available to the editors about the cases presented here is sometimes incomplete. Moreover, the cases may or may not have merit. Nevertheless, these cases represent the types of clinical situations that typically result in litigation and are meant to illustrate nationwide variation in jury verdicts and awards.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

Suture found in bladder after hysterectomy

A 40-year-old woman underwent a hysterectomy due to dysmenorrhea. Despite the presence of blood in the catheter bag after the procedure, the surgeon did not consult a urologist or perform a cystoscopy. Later, when the patient reported urinary retention, urinary leakage, and dyspareunia, a urologist performed a cystoscopy and discovered a suture in the bladder wall and a vesicovaginal fistula.

PATIENTS' CLAIM:

During the procedure, the gynecologic surgeon inadvertently placed a suture in the bladder wall. The presence of blood in the Foley catheter required an immediate urology consult and cystoscopy, during which the presence of the errant suture would have been discovered. Repair surgery then would have prevented subsequent injuries.

PHYSICIANS' DEFENSE:

The surgeon used reasonable judgment, as there were explanations for the blood in the catheter due to a difficult catheter placement and lysis of bladder adhesions.

VERDICT:

A Michigan defense verdict was returned.

Related article:
How to avoid intestinal and urinary tract injuries during gynecologic laparoscopy

Bowel injury during tubal ligation

A 40-year-old woman underwent laparoscopic tubal ligation using cauterization at an outpatient surgery center. Two hours after the procedure, her BP began to drop. She was promptly transferred to a hospital and underwent emergency surgery that revealed a bowel injury. Part of the patient’s small intestine was resected.

PATIENTS' CLAIM:

The gynecologic surgeon committed a medical error when she injured the bowel during trocar insertion.

DEFENDANTS' DEFENSE:

The bowel injury was a known complication of the surgery.

VERDICT:

A Louisiana defense verdict was returned.

Related article:
How to avoid major vessel injury during gynecologic laparoscopy

Colon injured twice: $1M settlement

A 59-year-old woman underwent laparoscopic total hysterectomy and salpingectomy. Her history included an umbilical hernia repair.

Two days after surgery, the patient experienced abdominal pain, chills, abdominal distention, and a foul-smelling discharge from her umbilical suture site. She went to the emergency department where a computed tomography scan revealed 2 injuries in the bowel. Emergency laparotomy included transverse colon resection and right colon colostomy with Hartmann’s pouch. She wore an ostomy bag for 8 months. She developed an infection because of the colostomy and also required operations to resolve a bowel obstruction and repair incisional hernias.

PATIENTS' CLAIM:

The gynecologic surgeon was negligent when performing the surgery. When he inserted the Veress needle and trocar through the patient’s umbilicus, the transverse colon was injured twice with a 3-cm anterior tear and a 1-cm posterior laceration. The injuries were not discovered during the procedure. He should have been more careful knowing that she had undergone prior umbilical hernia surgery.

PHYSICIANS' DEFENSE:

The case was settled before the trial began.

VERDICT:

A $1 million Virginia settlement was reached.

Chronic pain after sling procedure: $2M verdict

A 63-year-old woman reported urinary incontinence to her gynecologist, who performed a transobturator midurethral sling procedure. After surgery, the patient experienced pelvic pain, urinary urgency, intermittent incontinence, and dyspareunia. She returned to the gynecologist twice. He performed a cystoscopy after the second visit but found nothing wrong.

The patient sought a second opinion. A gynecologic surgeon found a large mass in the patient’s bladder consisting of a crystallized piece of tape that had been used to secure the sling supporting the bladder. The mass was removed and the patient reported that, although surgery alleviated many symptoms, she was not pain-free.

PATIENTS' CLAIM:

The gynecologist negligently inserted the end of the sling through one wall of her bladder and failed to detect the malpositioning during surgery or later. He failed to diagnose and treat bladder stones that resulted from the sling’s malpositioning. He failed to perform a cystoscopy when she first reported symptoms and improperly performed cystoscopy at the second visit.

DEFENDANTS' DEFENSE:

There was no negligence on the part of the gynecologist. The patient did not report ongoing symptoms until 1 year after sling insertion.

VERDICT:

A $2 million Pennsylvania verdict was returned.

These cases were selected by the editors of OBG Management from Medical Malpractice Verdicts, Settlements & Experts, with permission of the editor, Lewis Laska (www.verdictslaska.com). The information available to the editors about the cases presented here is sometimes incomplete. Moreover, the cases may or may not have merit. Nevertheless, these cases represent the types of clinical situations that typically result in litigation and are meant to illustrate nationwide variation in jury verdicts and awards.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

COLPOSCOPY BRUSHES SHOW BETTER TISSUE YIELD

A new study from the University of California–Riverside and Aurora Diagnostics in Palm Beach, Florida, evaluated 10,000 colposcopy workups and found that the disposable Histologics Soft-ECC and SoftBiopsy curettes were superior in tissue yield and offered a lower risk of cross contamination than metal curettes.

The Soft-ECC Endocervical Curette Tissue Collection System is used to biopsy the endocervical canal during colposcopy or evaluation for abnormal uterine bleeding. It gently frictionally abrades and collects transepithelial tissue samples into the Kylon fabric. The Soft-ECC-S has a smaller pad for the short, shallow, or stenotic cervix.

During exocervical biopsy with the SoftBiopsy Gynecological Biopsy Device, the Kylon fabric hooks rake across the tissue plane dislodging and shearing tissue strips and fragments from just below the basement membrane to collect in the fabric.

Both products have tips that are snapped off at the scored handle and placed in a fixative vial for transport to the laboratory.

FOR MORE INFORMATION, VISIT: https://www.histologics.com/

NONINVASIVE BODY CONTOURING

The Cynosure division of Hologic has just received US Food and Drug Administration (FDA) expanded clearance for SculpSure for noninvasive body contouring (lipolysis) of back, inner, and outer thighs. SculpSure is clinically proven to permanently eliminate fat cells and is already FDA-cleared to treat the abdomen and love handles (flanks).

According to Hologic, SculpSure uses a selective wavelength laser that precisely targets fat cells under the skin without affecting the skin’s surface. The laser raises the temperature of body fat to disrupt and destroy these cells, which are naturally eliminated over time and do not return or regenerate. Hologic says that patients are able to achieve desired results, without downtime or surgery, through customized treatment plans, each lasting only 25 minutes. Results can be seen as quickly as 6 weeks; optimal results typically are seen at 12 weeks, they say.

FOR MORE INFORMATION, VISIT: http://www.sculpsure.com

SOFTWARE PLATFORM FOR OBGYNS

drchrono offers software platforms for medical offices, including electronic health records (EHR), practice management, medical billing, revenue cycle management (RCM), and health care application programming interface (API) tools for iPad, iPhone, and web. Products are available for small and large practice groups, urgent care centers, and specialties, including ObGyns. A patient can complete forms and schedule visits through the Patient Portal as well as receive educational materials through HIPAA-compliant messaging and face-to-face telemedicine.

drchrono says its cloud-based platform allows ObGyns to chart in seconds using customizable medical forms, medical speech-to-text, and photo/drawing tools. ObGyn-specific ICD10, Current Procedural Terminology, and E&M codes can autopopulate into forms. Prenatal flow sheets and other clinical forms can be sent to L&D, other providers, or billing departments using drchrono’s direct messaging integration with the local hospital EHR or e-Fax. Prenatal and blood testing, ultrasounds, paper charts, and photographs can be ordered, tracked, and shared with patients and providers.

FOR MORE INFORMATION, VISIT: https://www.drchrono.com/

MAGNETIC DILATOR THERAPY FOR DYSPAREUNIA

The VuVa Magnetic Dilator Therapy is a nonsurgical, nonprescription program that VuVatech announces has been proven to relieve pelvic pain and dyspareunia caused by vaginismus, vulvodynia, and vaginal atrophy.

The VuVa Vaginal Dilator Set contains more than 60 neodymium magnets. With iron a component of blood that carries oxygen, when the magnet is placed next to a painful area, it draws fresh oxygenated blood to the nerves and surrounding muscles for increased blood circulation that accelerates healing while reducing pain. When a VuVa Magnetic Vaginal Dilator is used 20 minutes before intercourse, soft tissue lengthens, relaxing and calming muscles, ligaments, and nerves.

A nonmagnetic full dilator set is available for women who are trying to get pregnant and for women with pacemakers or defibrillators.

This product is not FDA approved, is not sold as a medical device, and is not intended to diagnose, treat, cure, or prevent any disease. Effectiveness varies, according to the manufacturer.

FOR MORE INFORMATION, VISIT: https://www.vuvatech.com/

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

COLPOSCOPY BRUSHES SHOW BETTER TISSUE YIELD

A new study from the University of California–Riverside and Aurora Diagnostics in Palm Beach, Florida, evaluated 10,000 colposcopy workups and found that the disposable Histologics Soft-ECC and SoftBiopsy curettes were superior in tissue yield and offered a lower risk of cross contamination than metal curettes.

The Soft-ECC Endocervical Curette Tissue Collection System is used to biopsy the endocervical canal during colposcopy or evaluation for abnormal uterine bleeding. It gently frictionally abrades and collects transepithelial tissue samples into the Kylon fabric. The Soft-ECC-S has a smaller pad for the short, shallow, or stenotic cervix.

During exocervical biopsy with the SoftBiopsy Gynecological Biopsy Device, the Kylon fabric hooks rake across the tissue plane dislodging and shearing tissue strips and fragments from just below the basement membrane to collect in the fabric.

Both products have tips that are snapped off at the scored handle and placed in a fixative vial for transport to the laboratory.

FOR MORE INFORMATION, VISIT: https://www.histologics.com/

NONINVASIVE BODY CONTOURING

The Cynosure division of Hologic has just received US Food and Drug Administration (FDA) expanded clearance for SculpSure for noninvasive body contouring (lipolysis) of back, inner, and outer thighs. SculpSure is clinically proven to permanently eliminate fat cells and is already FDA-cleared to treat the abdomen and love handles (flanks).

According to Hologic, SculpSure uses a selective wavelength laser that precisely targets fat cells under the skin without affecting the skin’s surface. The laser raises the temperature of body fat to disrupt and destroy these cells, which are naturally eliminated over time and do not return or regenerate. Hologic says that patients are able to achieve desired results, without downtime or surgery, through customized treatment plans, each lasting only 25 minutes. Results can be seen as quickly as 6 weeks; optimal results typically are seen at 12 weeks, they say.

FOR MORE INFORMATION, VISIT: http://www.sculpsure.com

SOFTWARE PLATFORM FOR OBGYNS

drchrono offers software platforms for medical offices, including electronic health records (EHR), practice management, medical billing, revenue cycle management (RCM), and health care application programming interface (API) tools for iPad, iPhone, and web. Products are available for small and large practice groups, urgent care centers, and specialties, including ObGyns. A patient can complete forms and schedule visits through the Patient Portal as well as receive educational materials through HIPAA-compliant messaging and face-to-face telemedicine.

drchrono says its cloud-based platform allows ObGyns to chart in seconds using customizable medical forms, medical speech-to-text, and photo/drawing tools. ObGyn-specific ICD10, Current Procedural Terminology, and E&M codes can autopopulate into forms. Prenatal flow sheets and other clinical forms can be sent to L&D, other providers, or billing departments using drchrono’s direct messaging integration with the local hospital EHR or e-Fax. Prenatal and blood testing, ultrasounds, paper charts, and photographs can be ordered, tracked, and shared with patients and providers.

FOR MORE INFORMATION, VISIT: https://www.drchrono.com/

MAGNETIC DILATOR THERAPY FOR DYSPAREUNIA

The VuVa Magnetic Dilator Therapy is a nonsurgical, nonprescription program that VuVatech announces has been proven to relieve pelvic pain and dyspareunia caused by vaginismus, vulvodynia, and vaginal atrophy.

The VuVa Vaginal Dilator Set contains more than 60 neodymium magnets. With iron a component of blood that carries oxygen, when the magnet is placed next to a painful area, it draws fresh oxygenated blood to the nerves and surrounding muscles for increased blood circulation that accelerates healing while reducing pain. When a VuVa Magnetic Vaginal Dilator is used 20 minutes before intercourse, soft tissue lengthens, relaxing and calming muscles, ligaments, and nerves.

A nonmagnetic full dilator set is available for women who are trying to get pregnant and for women with pacemakers or defibrillators.

This product is not FDA approved, is not sold as a medical device, and is not intended to diagnose, treat, cure, or prevent any disease. Effectiveness varies, according to the manufacturer.

FOR MORE INFORMATION, VISIT: https://www.vuvatech.com/

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

COLPOSCOPY BRUSHES SHOW BETTER TISSUE YIELD

A new study from the University of California–Riverside and Aurora Diagnostics in Palm Beach, Florida, evaluated 10,000 colposcopy workups and found that the disposable Histologics Soft-ECC and SoftBiopsy curettes were superior in tissue yield and offered a lower risk of cross contamination than metal curettes.

The Soft-ECC Endocervical Curette Tissue Collection System is used to biopsy the endocervical canal during colposcopy or evaluation for abnormal uterine bleeding. It gently frictionally abrades and collects transepithelial tissue samples into the Kylon fabric. The Soft-ECC-S has a smaller pad for the short, shallow, or stenotic cervix.

During exocervical biopsy with the SoftBiopsy Gynecological Biopsy Device, the Kylon fabric hooks rake across the tissue plane dislodging and shearing tissue strips and fragments from just below the basement membrane to collect in the fabric.

Both products have tips that are snapped off at the scored handle and placed in a fixative vial for transport to the laboratory.

FOR MORE INFORMATION, VISIT: https://www.histologics.com/

NONINVASIVE BODY CONTOURING

The Cynosure division of Hologic has just received US Food and Drug Administration (FDA) expanded clearance for SculpSure for noninvasive body contouring (lipolysis) of back, inner, and outer thighs. SculpSure is clinically proven to permanently eliminate fat cells and is already FDA-cleared to treat the abdomen and love handles (flanks).

According to Hologic, SculpSure uses a selective wavelength laser that precisely targets fat cells under the skin without affecting the skin’s surface. The laser raises the temperature of body fat to disrupt and destroy these cells, which are naturally eliminated over time and do not return or regenerate. Hologic says that patients are able to achieve desired results, without downtime or surgery, through customized treatment plans, each lasting only 25 minutes. Results can be seen as quickly as 6 weeks; optimal results typically are seen at 12 weeks, they say.

FOR MORE INFORMATION, VISIT: http://www.sculpsure.com

SOFTWARE PLATFORM FOR OBGYNS

drchrono offers software platforms for medical offices, including electronic health records (EHR), practice management, medical billing, revenue cycle management (RCM), and health care application programming interface (API) tools for iPad, iPhone, and web. Products are available for small and large practice groups, urgent care centers, and specialties, including ObGyns. A patient can complete forms and schedule visits through the Patient Portal as well as receive educational materials through HIPAA-compliant messaging and face-to-face telemedicine.

drchrono says its cloud-based platform allows ObGyns to chart in seconds using customizable medical forms, medical speech-to-text, and photo/drawing tools. ObGyn-specific ICD10, Current Procedural Terminology, and E&M codes can autopopulate into forms. Prenatal flow sheets and other clinical forms can be sent to L&D, other providers, or billing departments using drchrono’s direct messaging integration with the local hospital EHR or e-Fax. Prenatal and blood testing, ultrasounds, paper charts, and photographs can be ordered, tracked, and shared with patients and providers.

FOR MORE INFORMATION, VISIT: https://www.drchrono.com/

MAGNETIC DILATOR THERAPY FOR DYSPAREUNIA

The VuVa Magnetic Dilator Therapy is a nonsurgical, nonprescription program that VuVatech announces has been proven to relieve pelvic pain and dyspareunia caused by vaginismus, vulvodynia, and vaginal atrophy.

The VuVa Vaginal Dilator Set contains more than 60 neodymium magnets. With iron a component of blood that carries oxygen, when the magnet is placed next to a painful area, it draws fresh oxygenated blood to the nerves and surrounding muscles for increased blood circulation that accelerates healing while reducing pain. When a VuVa Magnetic Vaginal Dilator is used 20 minutes before intercourse, soft tissue lengthens, relaxing and calming muscles, ligaments, and nerves.

A nonmagnetic full dilator set is available for women who are trying to get pregnant and for women with pacemakers or defibrillators.

This product is not FDA approved, is not sold as a medical device, and is not intended to diagnose, treat, cure, or prevent any disease. Effectiveness varies, according to the manufacturer.

FOR MORE INFORMATION, VISIT: https://www.vuvatech.com/

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.