Gynecology

Emphasizing the benefits of the MMR vaccine for children appears to increase parents’ likelihood of vaccinating their child with it, according to a recent study.

But highlighting the societal benefits of giving their child the MMR (measles, mumps, and rubella) vaccine neither increased nor decreased their willingness to get their child the vaccine, Kristin Hendrix, Ph.D., of Indiana University in Indianapolis, and her colleagues reported online Aug. 18 (Pediatrics 2014;134:e675-e683).

In May 2012, the researchers provided one of four messages about the MMR vaccine to 802 parents of children less than 12 months of age. In a national online survey with the messages, the researchers asked the parents how likely they were, on a scale of 0 to 100 (extremely likely), to vaccinate their child with the MMR vaccine. Each message appeared online for 15 seconds, during which the parent could not navigate away.

Among the parents, 13% said they had ever refused a vaccine for their infant, 42% reported that all their children had received all the recommended vaccines, and 52% had no other children besides their infant. These parents were divided evenly across the four message groups.

One message was the Vaccine Information Statement (VIS) from the Centers for Disease Control and Prevention. The second was the VIS with additional information emphasizing the benefits of the MMR for their child, as follows: "The MMR vaccine protects your child from getting the diseases measles, mumps, or rubella or the complications caused by these diseases. After receiving this vaccine, your child will not miss school or activities due to these illnesses and will be able to play with friends during an outbreak."

The third message was the VIS and information emphasizing how society benefits from the MMR vaccine. It stated: "The MMR vaccine prevents your child from spreading measles, mumps, or rubella to those who cannot get the shot," and then listed those who could not get the shot. The fourth message emphasized both the child’s and society’s benefit, along with the VIS.

Parents rated the VIS-only message with an average of 86.3 on the likelihood-of-vaccinating scale. The VIS and society-only message did not increase parents’ likelihood of vaccinating (average, 86.4; P = .97), but the additional materials emphasizing the benefits to their child or to their child and society did (91.6 and 90.8; P = .01 and .03, respectively).

The research was supported by the Indiana Clinical and Translational Sciences Institute and the National Institutes of Health. The authors reported no disclosures.

Emphasizing the benefits of the MMR vaccine for children appears to increase parents’ likelihood of vaccinating their child with it, according to a recent study.

But highlighting the societal benefits of giving their child the MMR (measles, mumps, and rubella) vaccine neither increased nor decreased their willingness to get their child the vaccine, Kristin Hendrix, Ph.D., of Indiana University in Indianapolis, and her colleagues reported online Aug. 18 (Pediatrics 2014;134:e675-e683).

In May 2012, the researchers provided one of four messages about the MMR vaccine to 802 parents of children less than 12 months of age. In a national online survey with the messages, the researchers asked the parents how likely they were, on a scale of 0 to 100 (extremely likely), to vaccinate their child with the MMR vaccine. Each message appeared online for 15 seconds, during which the parent could not navigate away.

Among the parents, 13% said they had ever refused a vaccine for their infant, 42% reported that all their children had received all the recommended vaccines, and 52% had no other children besides their infant. These parents were divided evenly across the four message groups.

One message was the Vaccine Information Statement (VIS) from the Centers for Disease Control and Prevention. The second was the VIS with additional information emphasizing the benefits of the MMR for their child, as follows: "The MMR vaccine protects your child from getting the diseases measles, mumps, or rubella or the complications caused by these diseases. After receiving this vaccine, your child will not miss school or activities due to these illnesses and will be able to play with friends during an outbreak."

The third message was the VIS and information emphasizing how society benefits from the MMR vaccine. It stated: "The MMR vaccine prevents your child from spreading measles, mumps, or rubella to those who cannot get the shot," and then listed those who could not get the shot. The fourth message emphasized both the child’s and society’s benefit, along with the VIS.

Parents rated the VIS-only message with an average of 86.3 on the likelihood-of-vaccinating scale. The VIS and society-only message did not increase parents’ likelihood of vaccinating (average, 86.4; P = .97), but the additional materials emphasizing the benefits to their child or to their child and society did (91.6 and 90.8; P = .01 and .03, respectively).

The research was supported by the Indiana Clinical and Translational Sciences Institute and the National Institutes of Health. The authors reported no disclosures.

Emphasizing the benefits of the MMR vaccine for children appears to increase parents’ likelihood of vaccinating their child with it, according to a recent study.

But highlighting the societal benefits of giving their child the MMR (measles, mumps, and rubella) vaccine neither increased nor decreased their willingness to get their child the vaccine, Kristin Hendrix, Ph.D., of Indiana University in Indianapolis, and her colleagues reported online Aug. 18 (Pediatrics 2014;134:e675-e683).

In May 2012, the researchers provided one of four messages about the MMR vaccine to 802 parents of children less than 12 months of age. In a national online survey with the messages, the researchers asked the parents how likely they were, on a scale of 0 to 100 (extremely likely), to vaccinate their child with the MMR vaccine. Each message appeared online for 15 seconds, during which the parent could not navigate away.

Among the parents, 13% said they had ever refused a vaccine for their infant, 42% reported that all their children had received all the recommended vaccines, and 52% had no other children besides their infant. These parents were divided evenly across the four message groups.

One message was the Vaccine Information Statement (VIS) from the Centers for Disease Control and Prevention. The second was the VIS with additional information emphasizing the benefits of the MMR for their child, as follows: "The MMR vaccine protects your child from getting the diseases measles, mumps, or rubella or the complications caused by these diseases. After receiving this vaccine, your child will not miss school or activities due to these illnesses and will be able to play with friends during an outbreak."

The third message was the VIS and information emphasizing how society benefits from the MMR vaccine. It stated: "The MMR vaccine prevents your child from spreading measles, mumps, or rubella to those who cannot get the shot," and then listed those who could not get the shot. The fourth message emphasized both the child’s and society’s benefit, along with the VIS.

Parents rated the VIS-only message with an average of 86.3 on the likelihood-of-vaccinating scale. The VIS and society-only message did not increase parents’ likelihood of vaccinating (average, 86.4; P = .97), but the additional materials emphasizing the benefits to their child or to their child and society did (91.6 and 90.8; P = .01 and .03, respectively).

The research was supported by the Indiana Clinical and Translational Sciences Institute and the National Institutes of Health. The authors reported no disclosures.

MUNICH – A working group of the European Society of Human Reproduction and Embryology drafted the first international guidelines for managing premature ovarian insufficiency.

Once formally released, by late this year or soon after, the guidelines should "improve clinical practice and awareness of the condition," which affects roughly 1% of women, said Dr. Melanie Davies, a gynecologist at University College London Hospital and a working-group member who presented a few key items from the draft guidelines during a session at the society’s annual meeting.

Mitchel L. Zoler/Frontline Medical News

Women with premature ovarian insufficiency (POI) sometimes are treated for one aspect of POI by a physician "without full realization of the condition and its implications," Dr. Davies said in an interview. For example, "there have been fatal cases of women with Turner syndrome who received donor oocytes," the disorder posing the greatest risk to women receiving donor eggs. "This is a good example of where the guidelines may increase awareness," she said.

One draft excerpt Dr. Davies presented advises physicians and patients that candidates for donor oocytes suspected of having POI should undergo prior to receiving eggs a full investigation for thyroid and adrenal function and karyotype. "Pregnancy in some women can be of such high risk that clinicians may consider egg donation life threatening and inappropriate," she said.

For women with Turner syndrome, the guidelines call for assessment by a cardiologist with a special interest in adult congenital heart disease, as well as a general medical and endocrine examination prior to pregnancy. During pregnancy, these women have an elevated risk for obstetric complications and should be managed in an obstetric unit designed for high-risk pregnancies with involvement of a cardiologist.

The draft defines POI as depletion of follicular activity before age 40 years with menstrual disturbance, raised gonadotropin levels, and low estradiol levels. These women should understand that no interventions are proven to reliably increase ovarian activity and their natural conception rate. But physicians also can reassure these women that spontaneous pregnancy after idiopathic POI or most forms of chemotherapy has no higher obstetric or neonatal risk than in the general population.

Pregnancy in women who received cancer treatment is increasingly common, Dr. Davies said in her talk at the meeting. Women who received ovarian irradiation face an increased risk of pregnancy complications and should be managed accordingly. Women who received treatment with an anthracycline, high-dose cyclophosphamide, or cardiac irradiation should undergo echocardiography before pregnancy, and prenatal care should include cardiology assessment.

The draft guidelines contain a total of 13 chapters addressing 31 key issues, ranging from symptoms and diagnosis, complications including bone and cardiovascular health, sexual function, and quality of life. The 17-member working group included a patient representative as well as experts from psychology, cardiology, endocrinology, internal medicine, and ob.gyn. In mid-August, the ESHRE website said that posting of the draft version should occur later in August. Once posted, ESHRE will open a 6-week comment period. The final version should appear by late 2014, Dr. Davies said.

She said she had no relevant financial disclosures.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

MUNICH – A working group of the European Society of Human Reproduction and Embryology drafted the first international guidelines for managing premature ovarian insufficiency.

Once formally released, by late this year or soon after, the guidelines should "improve clinical practice and awareness of the condition," which affects roughly 1% of women, said Dr. Melanie Davies, a gynecologist at University College London Hospital and a working-group member who presented a few key items from the draft guidelines during a session at the society’s annual meeting.

Mitchel L. Zoler/Frontline Medical News

Women with premature ovarian insufficiency (POI) sometimes are treated for one aspect of POI by a physician "without full realization of the condition and its implications," Dr. Davies said in an interview. For example, "there have been fatal cases of women with Turner syndrome who received donor oocytes," the disorder posing the greatest risk to women receiving donor eggs. "This is a good example of where the guidelines may increase awareness," she said.

One draft excerpt Dr. Davies presented advises physicians and patients that candidates for donor oocytes suspected of having POI should undergo prior to receiving eggs a full investigation for thyroid and adrenal function and karyotype. "Pregnancy in some women can be of such high risk that clinicians may consider egg donation life threatening and inappropriate," she said.

For women with Turner syndrome, the guidelines call for assessment by a cardiologist with a special interest in adult congenital heart disease, as well as a general medical and endocrine examination prior to pregnancy. During pregnancy, these women have an elevated risk for obstetric complications and should be managed in an obstetric unit designed for high-risk pregnancies with involvement of a cardiologist.

The draft defines POI as depletion of follicular activity before age 40 years with menstrual disturbance, raised gonadotropin levels, and low estradiol levels. These women should understand that no interventions are proven to reliably increase ovarian activity and their natural conception rate. But physicians also can reassure these women that spontaneous pregnancy after idiopathic POI or most forms of chemotherapy has no higher obstetric or neonatal risk than in the general population.

Pregnancy in women who received cancer treatment is increasingly common, Dr. Davies said in her talk at the meeting. Women who received ovarian irradiation face an increased risk of pregnancy complications and should be managed accordingly. Women who received treatment with an anthracycline, high-dose cyclophosphamide, or cardiac irradiation should undergo echocardiography before pregnancy, and prenatal care should include cardiology assessment.

The draft guidelines contain a total of 13 chapters addressing 31 key issues, ranging from symptoms and diagnosis, complications including bone and cardiovascular health, sexual function, and quality of life. The 17-member working group included a patient representative as well as experts from psychology, cardiology, endocrinology, internal medicine, and ob.gyn. In mid-August, the ESHRE website said that posting of the draft version should occur later in August. Once posted, ESHRE will open a 6-week comment period. The final version should appear by late 2014, Dr. Davies said.

She said she had no relevant financial disclosures.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

MUNICH – A working group of the European Society of Human Reproduction and Embryology drafted the first international guidelines for managing premature ovarian insufficiency.

Once formally released, by late this year or soon after, the guidelines should "improve clinical practice and awareness of the condition," which affects roughly 1% of women, said Dr. Melanie Davies, a gynecologist at University College London Hospital and a working-group member who presented a few key items from the draft guidelines during a session at the society’s annual meeting.

Mitchel L. Zoler/Frontline Medical News

Women with premature ovarian insufficiency (POI) sometimes are treated for one aspect of POI by a physician "without full realization of the condition and its implications," Dr. Davies said in an interview. For example, "there have been fatal cases of women with Turner syndrome who received donor oocytes," the disorder posing the greatest risk to women receiving donor eggs. "This is a good example of where the guidelines may increase awareness," she said.

One draft excerpt Dr. Davies presented advises physicians and patients that candidates for donor oocytes suspected of having POI should undergo prior to receiving eggs a full investigation for thyroid and adrenal function and karyotype. "Pregnancy in some women can be of such high risk that clinicians may consider egg donation life threatening and inappropriate," she said.

For women with Turner syndrome, the guidelines call for assessment by a cardiologist with a special interest in adult congenital heart disease, as well as a general medical and endocrine examination prior to pregnancy. During pregnancy, these women have an elevated risk for obstetric complications and should be managed in an obstetric unit designed for high-risk pregnancies with involvement of a cardiologist.

The draft defines POI as depletion of follicular activity before age 40 years with menstrual disturbance, raised gonadotropin levels, and low estradiol levels. These women should understand that no interventions are proven to reliably increase ovarian activity and their natural conception rate. But physicians also can reassure these women that spontaneous pregnancy after idiopathic POI or most forms of chemotherapy has no higher obstetric or neonatal risk than in the general population.

Pregnancy in women who received cancer treatment is increasingly common, Dr. Davies said in her talk at the meeting. Women who received ovarian irradiation face an increased risk of pregnancy complications and should be managed accordingly. Women who received treatment with an anthracycline, high-dose cyclophosphamide, or cardiac irradiation should undergo echocardiography before pregnancy, and prenatal care should include cardiology assessment.

The draft guidelines contain a total of 13 chapters addressing 31 key issues, ranging from symptoms and diagnosis, complications including bone and cardiovascular health, sexual function, and quality of life. The 17-member working group included a patient representative as well as experts from psychology, cardiology, endocrinology, internal medicine, and ob.gyn. In mid-August, the ESHRE website said that posting of the draft version should occur later in August. Once posted, ESHRE will open a 6-week comment period. The final version should appear by late 2014, Dr. Davies said.

She said she had no relevant financial disclosures.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

WASHINGTON – Repeat treatment with onabotulinumtoxin A provided sustained improvements in the symptoms of overactive bladder and was well tolerated in women who were followed for a median 2.4 years beyond their participation in one of the two large clinical trials that established the agent’s effectiveness and safety for this indication.

"This treatment remains a safe and effective therapeutic option" for patients with overactive bladder, said Dr. Tomasz Rechberger of the Medical University of Lublin (Poland). It’s "an attractive alternative [in the longer term] for patients who were inadequately treated with anticholinergics."

Women who completed either of the placebo-controlled, multicenter phase III studies were given the option of entering a 3-year open-label extension study in which they could receive additional treatments upon request and as needed to maintain symptom control. The intradetrusor injections of 100 U of onabotulinumtoxin A (Botox) needed to be at least 12 weeks apart.

At the scientific meetings of the American Urogynecologic Society and the International Urogynecological Association, Dr. Rechberger reported on an interim analysis of this extension study, which was scheduled to end in August 2014.

As of June 2014, the overall discontinuation rate among the 749 patients who entered the extension study was 38%, but only 4.5% discontinued because of adverse effects or a lack of efficacy. "It was extremely low – much lower than [we expected]," said Dr. Rechberger.

The women had a mean age of 60 and had experienced symptoms of overactive bladder (OAB) for more than 6 years. At the start of the extension study, they had a mean of 5.6 episodes per day of urinary incontinence, 11.6 micturitions per day, and 8.4 urgency episodes per day.

In the original studies, the results after 12 weeks showed that patients treated with Botox experienced urinary incontinence an average of 1.6-1.9 times fewer per day than did patients treated with placebo, and they needed to urinate on average 1.0-1.7 times fewer per day, according to the Food and Drug Administration. In 2013, the FDA approved the use of Botox to treat adults with OAB who cannot use or do not adequately respond to anticholinergics.

Consistent reductions in symptoms were seen after the one to five treatments evaluated as part of the interim analysis of the extension study. Investigators checked all endpoints against the baseline 12 weeks after each treatment. The number of urinary incontinence episodes per day, for instance, was reduced by 3.3 after the first treatment cycle, 3.7 after two treatments, 3.9 after the third treatment, and 3.2 after the fourth and fifth treatment cycles.

Approximately 63%-72% of patients achieved a reduction of incontinence episodes of at least 50% across the treatment cycles.

Additionally, women saw mean reductions in micturition ranging from 2.4 to 3 over the five treatment cycles, and mean reductions in urgency episodes ranging from 3.6 to 4.2. A consistent increase in the volume voided per micturition also was seen.

Urinary tract infection was the most common side effect in each repeat treatment, as was the case in the original studies, but declined slightly with each treatment cycle, from approximately 30% after the first treatment to approximately 20% after the fifth. There were no new safety signals, Dr. Rechberger reported.

Each treatment consisted of 20 cystoscopic injections of 0.5 mL each. The median time between treatments ranged from 24 to 33 weeks – significantly longer than the required 12-week minimum.

Dr. Rechberger is an advisory committee member for Allergan (maker of Botox) and consults for Astellas and Johnson & Johnson. The study was funded by Allergan.

WASHINGTON – Repeat treatment with onabotulinumtoxin A provided sustained improvements in the symptoms of overactive bladder and was well tolerated in women who were followed for a median 2.4 years beyond their participation in one of the two large clinical trials that established the agent’s effectiveness and safety for this indication.

"This treatment remains a safe and effective therapeutic option" for patients with overactive bladder, said Dr. Tomasz Rechberger of the Medical University of Lublin (Poland). It’s "an attractive alternative [in the longer term] for patients who were inadequately treated with anticholinergics."

Women who completed either of the placebo-controlled, multicenter phase III studies were given the option of entering a 3-year open-label extension study in which they could receive additional treatments upon request and as needed to maintain symptom control. The intradetrusor injections of 100 U of onabotulinumtoxin A (Botox) needed to be at least 12 weeks apart.

At the scientific meetings of the American Urogynecologic Society and the International Urogynecological Association, Dr. Rechberger reported on an interim analysis of this extension study, which was scheduled to end in August 2014.

As of June 2014, the overall discontinuation rate among the 749 patients who entered the extension study was 38%, but only 4.5% discontinued because of adverse effects or a lack of efficacy. "It was extremely low – much lower than [we expected]," said Dr. Rechberger.

The women had a mean age of 60 and had experienced symptoms of overactive bladder (OAB) for more than 6 years. At the start of the extension study, they had a mean of 5.6 episodes per day of urinary incontinence, 11.6 micturitions per day, and 8.4 urgency episodes per day.

In the original studies, the results after 12 weeks showed that patients treated with Botox experienced urinary incontinence an average of 1.6-1.9 times fewer per day than did patients treated with placebo, and they needed to urinate on average 1.0-1.7 times fewer per day, according to the Food and Drug Administration. In 2013, the FDA approved the use of Botox to treat adults with OAB who cannot use or do not adequately respond to anticholinergics.

Consistent reductions in symptoms were seen after the one to five treatments evaluated as part of the interim analysis of the extension study. Investigators checked all endpoints against the baseline 12 weeks after each treatment. The number of urinary incontinence episodes per day, for instance, was reduced by 3.3 after the first treatment cycle, 3.7 after two treatments, 3.9 after the third treatment, and 3.2 after the fourth and fifth treatment cycles.

Approximately 63%-72% of patients achieved a reduction of incontinence episodes of at least 50% across the treatment cycles.

Additionally, women saw mean reductions in micturition ranging from 2.4 to 3 over the five treatment cycles, and mean reductions in urgency episodes ranging from 3.6 to 4.2. A consistent increase in the volume voided per micturition also was seen.

Urinary tract infection was the most common side effect in each repeat treatment, as was the case in the original studies, but declined slightly with each treatment cycle, from approximately 30% after the first treatment to approximately 20% after the fifth. There were no new safety signals, Dr. Rechberger reported.

Each treatment consisted of 20 cystoscopic injections of 0.5 mL each. The median time between treatments ranged from 24 to 33 weeks – significantly longer than the required 12-week minimum.

Dr. Rechberger is an advisory committee member for Allergan (maker of Botox) and consults for Astellas and Johnson & Johnson. The study was funded by Allergan.

WASHINGTON – Repeat treatment with onabotulinumtoxin A provided sustained improvements in the symptoms of overactive bladder and was well tolerated in women who were followed for a median 2.4 years beyond their participation in one of the two large clinical trials that established the agent’s effectiveness and safety for this indication.

"This treatment remains a safe and effective therapeutic option" for patients with overactive bladder, said Dr. Tomasz Rechberger of the Medical University of Lublin (Poland). It’s "an attractive alternative [in the longer term] for patients who were inadequately treated with anticholinergics."

Women who completed either of the placebo-controlled, multicenter phase III studies were given the option of entering a 3-year open-label extension study in which they could receive additional treatments upon request and as needed to maintain symptom control. The intradetrusor injections of 100 U of onabotulinumtoxin A (Botox) needed to be at least 12 weeks apart.

At the scientific meetings of the American Urogynecologic Society and the International Urogynecological Association, Dr. Rechberger reported on an interim analysis of this extension study, which was scheduled to end in August 2014.

As of June 2014, the overall discontinuation rate among the 749 patients who entered the extension study was 38%, but only 4.5% discontinued because of adverse effects or a lack of efficacy. "It was extremely low – much lower than [we expected]," said Dr. Rechberger.

The women had a mean age of 60 and had experienced symptoms of overactive bladder (OAB) for more than 6 years. At the start of the extension study, they had a mean of 5.6 episodes per day of urinary incontinence, 11.6 micturitions per day, and 8.4 urgency episodes per day.

In the original studies, the results after 12 weeks showed that patients treated with Botox experienced urinary incontinence an average of 1.6-1.9 times fewer per day than did patients treated with placebo, and they needed to urinate on average 1.0-1.7 times fewer per day, according to the Food and Drug Administration. In 2013, the FDA approved the use of Botox to treat adults with OAB who cannot use or do not adequately respond to anticholinergics.

Consistent reductions in symptoms were seen after the one to five treatments evaluated as part of the interim analysis of the extension study. Investigators checked all endpoints against the baseline 12 weeks after each treatment. The number of urinary incontinence episodes per day, for instance, was reduced by 3.3 after the first treatment cycle, 3.7 after two treatments, 3.9 after the third treatment, and 3.2 after the fourth and fifth treatment cycles.

Approximately 63%-72% of patients achieved a reduction of incontinence episodes of at least 50% across the treatment cycles.

Additionally, women saw mean reductions in micturition ranging from 2.4 to 3 over the five treatment cycles, and mean reductions in urgency episodes ranging from 3.6 to 4.2. A consistent increase in the volume voided per micturition also was seen.

Urinary tract infection was the most common side effect in each repeat treatment, as was the case in the original studies, but declined slightly with each treatment cycle, from approximately 30% after the first treatment to approximately 20% after the fifth. There were no new safety signals, Dr. Rechberger reported.

Each treatment consisted of 20 cystoscopic injections of 0.5 mL each. The median time between treatments ranged from 24 to 33 weeks – significantly longer than the required 12-week minimum.

Dr. Rechberger is an advisory committee member for Allergan (maker of Botox) and consults for Astellas and Johnson & Johnson. The study was funded by Allergan.

WASHINGTON – A large proportion of female triathletes who responded to a national Web-based survey have symptoms of pelvic floor disorders, and one in four screened positive for the female athlete triad.

These findings from women in the general population, with a median age range of 35-44 years, echo findings from studies of Olympic and professional athletes, and "show that even young, thin, and otherwise healthy endurance athletes [who are not professional athletes] have pelvic floor disorders," said Dr. Johnny Yi after presenting his findings in a press conference at the scientific meetings of the American Urogynecologic Society and the International Urogynecological Association.

© Fuse/Thinkstock

Currently, "these women may not get screened because they are not believed to be in a high-risk group," said Dr. Yi, a urogynecologist in group practice in Denver.

Of 311 women who responded to the survey, 37% reported symptoms of stress urinary incontinence, and 16% reported symptoms of urgency urinary incontinence. Anal incontinence was also a problem, with 37% reporting symptoms of this condition. Pelvic organ prolapse symptoms were reported by 5%.

Most of the participants were white (90%), nonsmokers (99%), and premenopausal (80%), and had a mean body mass index of 22 kg/m². About half had borne children, almost all of them had vaginal deliveries.

The women were invited to participate through a database of nationwide triathlon interest groups and a triathlete Internet forum. The survey included the Epidemiology of Prolapse and Incontinence Questionnaire (EPIQ) and the Pelvic Girdle Pain Questionnaire (PGPQ), both of which are validated tools; the Female Athlete Triad Screening Questionnaire, which is endorsed by the National Collegiate Athletic Association; and various medical and demographic questions.

Approximately 18% of the women had pelvic girdle pain, although the mean score on the PGPQ (35.6) was relatively low. Respondents with various types of incontinence reported higher levels of pelvic girdle pain, Dr. Yi said.

Of the 75% of respondents who completed the triad questionnaire, 22% screened positive for low energy availability, 24% for menstrual irregularities, and 29% for abnormal bone strength. Eight percent screened positive for all three components of the female athlete triad, which is characterized by a hypoestrogenic state similar to menopause.

Dr. Yi said he is particularly interested in possible associations between the female athlete triad and pelvic floor disorders, and in the pelvic floor consequences of coupling high-impact, high-endurance activity with the potential for a hypoestrogenic state.

This study showed no significant association between the triad and pelvic floor disorders, but the findings emphasize that "both disorders are prevalent" and should be screened for and treated to avoid long-term sequelae and improve quality of life, he said.

Weekly training of the study participants consisted of running for a mean of 3.7 days, biking for a mean of 2.9 days, and swimming for a mean of 2.4 days. Training mileage and intensity were not associated with pelvic floor disorders. Not unexpectedly, parity was associated with a higher prevalence of stress urinary incontinence and pelvic organ prolapse.

Dr. Yi and his coinvestigators reported no disclosures.

WASHINGTON – A large proportion of female triathletes who responded to a national Web-based survey have symptoms of pelvic floor disorders, and one in four screened positive for the female athlete triad.

These findings from women in the general population, with a median age range of 35-44 years, echo findings from studies of Olympic and professional athletes, and "show that even young, thin, and otherwise healthy endurance athletes [who are not professional athletes] have pelvic floor disorders," said Dr. Johnny Yi after presenting his findings in a press conference at the scientific meetings of the American Urogynecologic Society and the International Urogynecological Association.

© Fuse/Thinkstock

Currently, "these women may not get screened because they are not believed to be in a high-risk group," said Dr. Yi, a urogynecologist in group practice in Denver.

Of 311 women who responded to the survey, 37% reported symptoms of stress urinary incontinence, and 16% reported symptoms of urgency urinary incontinence. Anal incontinence was also a problem, with 37% reporting symptoms of this condition. Pelvic organ prolapse symptoms were reported by 5%.

Most of the participants were white (90%), nonsmokers (99%), and premenopausal (80%), and had a mean body mass index of 22 kg/m². About half had borne children, almost all of them had vaginal deliveries.

The women were invited to participate through a database of nationwide triathlon interest groups and a triathlete Internet forum. The survey included the Epidemiology of Prolapse and Incontinence Questionnaire (EPIQ) and the Pelvic Girdle Pain Questionnaire (PGPQ), both of which are validated tools; the Female Athlete Triad Screening Questionnaire, which is endorsed by the National Collegiate Athletic Association; and various medical and demographic questions.

Approximately 18% of the women had pelvic girdle pain, although the mean score on the PGPQ (35.6) was relatively low. Respondents with various types of incontinence reported higher levels of pelvic girdle pain, Dr. Yi said.

Of the 75% of respondents who completed the triad questionnaire, 22% screened positive for low energy availability, 24% for menstrual irregularities, and 29% for abnormal bone strength. Eight percent screened positive for all three components of the female athlete triad, which is characterized by a hypoestrogenic state similar to menopause.

Dr. Yi said he is particularly interested in possible associations between the female athlete triad and pelvic floor disorders, and in the pelvic floor consequences of coupling high-impact, high-endurance activity with the potential for a hypoestrogenic state.

This study showed no significant association between the triad and pelvic floor disorders, but the findings emphasize that "both disorders are prevalent" and should be screened for and treated to avoid long-term sequelae and improve quality of life, he said.

Weekly training of the study participants consisted of running for a mean of 3.7 days, biking for a mean of 2.9 days, and swimming for a mean of 2.4 days. Training mileage and intensity were not associated with pelvic floor disorders. Not unexpectedly, parity was associated with a higher prevalence of stress urinary incontinence and pelvic organ prolapse.

Dr. Yi and his coinvestigators reported no disclosures.

WASHINGTON – A large proportion of female triathletes who responded to a national Web-based survey have symptoms of pelvic floor disorders, and one in four screened positive for the female athlete triad.

These findings from women in the general population, with a median age range of 35-44 years, echo findings from studies of Olympic and professional athletes, and "show that even young, thin, and otherwise healthy endurance athletes [who are not professional athletes] have pelvic floor disorders," said Dr. Johnny Yi after presenting his findings in a press conference at the scientific meetings of the American Urogynecologic Society and the International Urogynecological Association.

© Fuse/Thinkstock

Currently, "these women may not get screened because they are not believed to be in a high-risk group," said Dr. Yi, a urogynecologist in group practice in Denver.

Of 311 women who responded to the survey, 37% reported symptoms of stress urinary incontinence, and 16% reported symptoms of urgency urinary incontinence. Anal incontinence was also a problem, with 37% reporting symptoms of this condition. Pelvic organ prolapse symptoms were reported by 5%.

Most of the participants were white (90%), nonsmokers (99%), and premenopausal (80%), and had a mean body mass index of 22 kg/m². About half had borne children, almost all of them had vaginal deliveries.

The women were invited to participate through a database of nationwide triathlon interest groups and a triathlete Internet forum. The survey included the Epidemiology of Prolapse and Incontinence Questionnaire (EPIQ) and the Pelvic Girdle Pain Questionnaire (PGPQ), both of which are validated tools; the Female Athlete Triad Screening Questionnaire, which is endorsed by the National Collegiate Athletic Association; and various medical and demographic questions.

Approximately 18% of the women had pelvic girdle pain, although the mean score on the PGPQ (35.6) was relatively low. Respondents with various types of incontinence reported higher levels of pelvic girdle pain, Dr. Yi said.

Of the 75% of respondents who completed the triad questionnaire, 22% screened positive for low energy availability, 24% for menstrual irregularities, and 29% for abnormal bone strength. Eight percent screened positive for all three components of the female athlete triad, which is characterized by a hypoestrogenic state similar to menopause.

Dr. Yi said he is particularly interested in possible associations between the female athlete triad and pelvic floor disorders, and in the pelvic floor consequences of coupling high-impact, high-endurance activity with the potential for a hypoestrogenic state.

This study showed no significant association between the triad and pelvic floor disorders, but the findings emphasize that "both disorders are prevalent" and should be screened for and treated to avoid long-term sequelae and improve quality of life, he said.

Weekly training of the study participants consisted of running for a mean of 3.7 days, biking for a mean of 2.9 days, and swimming for a mean of 2.4 days. Training mileage and intensity were not associated with pelvic floor disorders. Not unexpectedly, parity was associated with a higher prevalence of stress urinary incontinence and pelvic organ prolapse.

Dr. Yi and his coinvestigators reported no disclosures.

Breastfeeding among newborns is on the rise, according to the 2014 Breastfeeding Report Card released by the Centers for Disease Control and Prevention.

Among babies born in 2011, 79.2% were breastfed at some point, up from the previous year’s report card in which only 76.5% reached that mark.*

In addition, breastfeeding was reported in 49% at age 6 months and 27% at age 12 months, findings that held steady from the last report. Two in five infants (41%) were exclusively breastfeeding at age 3 months and 19% at age 6 months. These findings are based on the 2012 and 2013 U.S. National Immunization Surveys conducted using calls to families with children aged 19-35 months.

The report card provides data on several goals included as part of the Healthy People 2020 Objectives, which aims to increase the percentage of babies who were ever breastfed to 82%. Additionally, the percentage of breastfeeding babies at age 6 months should be at least 61%, and at 1 year, at least 34%.

The objectives also include ensuring that at least 46% of babies are exclusively breastfeeding at 3 months and that at least 26% are doing so at 6 months.

Currently, 19% of breastfed infants received formula before they were 2 days old, which is higher than the 14% goal for Healthy People 2020.

The report card also shows closer progress toward the goal of 8% of live births occurring at Baby-Friendly facilities, which provide the recommended care for lactating mothers and their babies. Baby-Friendly hospitals must follow the “Ten Steps to Successful Breastfeeding” and the International Code of Marketing of Breast-milk Substitutes established by the World Health Organization.

In addition to the Baby-Friendly Initiative, the CDC also conducts a survey to establish a Maternity Practices in Infant Nutrition and Care (mPINC) score, which measures breastfeeding-related maternity care practices across the United States. The national average in this year’s report card is 75, with numbers that range from a low of 59 in Mississippi to a high of 91 in New Hampshire.

The breastfeeding report card tracks the number of those providing professional lactation support, which has been increasing since the metric was added in 2006. The number of International Board Certified Lactation Consultants (IBCLCs) has climbed from 2.1 to 3.5 per 1,000 live births between 2006 and 2013, based on data provided from the International Board of Lactation Consultant Examiners.

The number of Certified Lactation Counselors (CLCs) also has increased from 2.5 to 3.8 CLCs per 1,000 live births from 2011 to 2013. In addition, at least six CLCs per 1,000 births exist in 19 states, according to the Academy of Lactation Policy and Practice. The number of La Leche League Leaders per 1,000 births is 0.9, about the same as the 0.92 number from last year’s report card.

The research is supported by the Centers for Disease Control and Prevention. No disclosures were noted.

*Correction, 8/1/2014: A previous version of this article misstated the birth year addressed in the 2014 report.

Breastfeeding among newborns is on the rise, according to the 2014 Breastfeeding Report Card released by the Centers for Disease Control and Prevention.

Among babies born in 2011, 79.2% were breastfed at some point, up from the previous year’s report card in which only 76.5% reached that mark.*

In addition, breastfeeding was reported in 49% at age 6 months and 27% at age 12 months, findings that held steady from the last report. Two in five infants (41%) were exclusively breastfeeding at age 3 months and 19% at age 6 months. These findings are based on the 2012 and 2013 U.S. National Immunization Surveys conducted using calls to families with children aged 19-35 months.

The report card provides data on several goals included as part of the Healthy People 2020 Objectives, which aims to increase the percentage of babies who were ever breastfed to 82%. Additionally, the percentage of breastfeeding babies at age 6 months should be at least 61%, and at 1 year, at least 34%.

The objectives also include ensuring that at least 46% of babies are exclusively breastfeeding at 3 months and that at least 26% are doing so at 6 months.

Currently, 19% of breastfed infants received formula before they were 2 days old, which is higher than the 14% goal for Healthy People 2020.

The report card also shows closer progress toward the goal of 8% of live births occurring at Baby-Friendly facilities, which provide the recommended care for lactating mothers and their babies. Baby-Friendly hospitals must follow the “Ten Steps to Successful Breastfeeding” and the International Code of Marketing of Breast-milk Substitutes established by the World Health Organization.

In addition to the Baby-Friendly Initiative, the CDC also conducts a survey to establish a Maternity Practices in Infant Nutrition and Care (mPINC) score, which measures breastfeeding-related maternity care practices across the United States. The national average in this year’s report card is 75, with numbers that range from a low of 59 in Mississippi to a high of 91 in New Hampshire.

The breastfeeding report card tracks the number of those providing professional lactation support, which has been increasing since the metric was added in 2006. The number of International Board Certified Lactation Consultants (IBCLCs) has climbed from 2.1 to 3.5 per 1,000 live births between 2006 and 2013, based on data provided from the International Board of Lactation Consultant Examiners.

The number of Certified Lactation Counselors (CLCs) also has increased from 2.5 to 3.8 CLCs per 1,000 live births from 2011 to 2013. In addition, at least six CLCs per 1,000 births exist in 19 states, according to the Academy of Lactation Policy and Practice. The number of La Leche League Leaders per 1,000 births is 0.9, about the same as the 0.92 number from last year’s report card.

The research is supported by the Centers for Disease Control and Prevention. No disclosures were noted.

*Correction, 8/1/2014: A previous version of this article misstated the birth year addressed in the 2014 report.

Breastfeeding among newborns is on the rise, according to the 2014 Breastfeeding Report Card released by the Centers for Disease Control and Prevention.

Among babies born in 2011, 79.2% were breastfed at some point, up from the previous year’s report card in which only 76.5% reached that mark.*

In addition, breastfeeding was reported in 49% at age 6 months and 27% at age 12 months, findings that held steady from the last report. Two in five infants (41%) were exclusively breastfeeding at age 3 months and 19% at age 6 months. These findings are based on the 2012 and 2013 U.S. National Immunization Surveys conducted using calls to families with children aged 19-35 months.

The report card provides data on several goals included as part of the Healthy People 2020 Objectives, which aims to increase the percentage of babies who were ever breastfed to 82%. Additionally, the percentage of breastfeeding babies at age 6 months should be at least 61%, and at 1 year, at least 34%.

The objectives also include ensuring that at least 46% of babies are exclusively breastfeeding at 3 months and that at least 26% are doing so at 6 months.

Currently, 19% of breastfed infants received formula before they were 2 days old, which is higher than the 14% goal for Healthy People 2020.

The report card also shows closer progress toward the goal of 8% of live births occurring at Baby-Friendly facilities, which provide the recommended care for lactating mothers and their babies. Baby-Friendly hospitals must follow the “Ten Steps to Successful Breastfeeding” and the International Code of Marketing of Breast-milk Substitutes established by the World Health Organization.

In addition to the Baby-Friendly Initiative, the CDC also conducts a survey to establish a Maternity Practices in Infant Nutrition and Care (mPINC) score, which measures breastfeeding-related maternity care practices across the United States. The national average in this year’s report card is 75, with numbers that range from a low of 59 in Mississippi to a high of 91 in New Hampshire.

The breastfeeding report card tracks the number of those providing professional lactation support, which has been increasing since the metric was added in 2006. The number of International Board Certified Lactation Consultants (IBCLCs) has climbed from 2.1 to 3.5 per 1,000 live births between 2006 and 2013, based on data provided from the International Board of Lactation Consultant Examiners.

The number of Certified Lactation Counselors (CLCs) also has increased from 2.5 to 3.8 CLCs per 1,000 live births from 2011 to 2013. In addition, at least six CLCs per 1,000 births exist in 19 states, according to the Academy of Lactation Policy and Practice. The number of La Leche League Leaders per 1,000 births is 0.9, about the same as the 0.92 number from last year’s report card.

The research is supported by the Centers for Disease Control and Prevention. No disclosures were noted.

*Correction, 8/1/2014: A previous version of this article misstated the birth year addressed in the 2014 report.

WASHINGTON – Bowel preparation for vaginal reconstructive surgery does not affect postoperative bowel function and bowel symptoms one way or the other, according to a secondary analysis of a single-blind randomized trial examining various effects of mechanical bowel preparation.

In a primary analysis published earlier this year, investigators found no benefit to mechanical bowel preparation with regard to the operative field quality. They also found that patients who were randomized not to receive bowel preparation were more satisfied and had fewer abdominal symptoms than those who received the intervention – a clear-liquid diet and enemas (Obstet. Gynecol. 2014;123:232-8).

The new analysis, reported at the scientific meetings of the American Urogynecologic Society and the International Urogynecological Association, looked more closely at postoperative bowel habits after vaginal reconstructive surgery.

"As surgical intervention for pelvic organ prolapse increases, so does our need for knowledge of [best] perioperative management practices," said Dr. Alicia C. Ballard of the division of urogynecology and pelvic reconstructive surgery at the University of Alabama at Birmingham, where the study was conducted.

"Concerns about painful defecation and GI symptoms such as nausea and vomiting are significant concerns for women undergoing surgery," she said.

Women may be predisposed to postsurgical constipation as a result of preoperative bowel preparation (including diet), the lasting effects of anesthesia, the use of narcotics, and the surgery itself. Prior research has shown, moreover, that constipation and incomplete bowel evacuation are not uncommon preoperatively in women with pelvic organ prolapse, she noted.

The study randomized 150 women scheduled to undergo vaginal prolapse surgery with, at a minimum, a planned apical suspension and posterior compartment repair. Surgeries included other prolapse and incontinence procedures.

Women randomized to the bowel preparation group were instructed to have a clear-liquid diet and to self-administer two saline enemas in the late afternoon of the day before surgery.

Those who were randomized to receive no intervention were allowed to have a regular diet. Women in both groups were instructed to eat nothing after midnight on the day of surgery.

All study participants were instructed to complete a bowel diary for 7 days preoperatively and 14 days postoperatively. Those who completed the preoperative diary and 10 of 14 days of the postoperative diary were included in the analysis.

Of the 150 women randomized at the preoperative visit in a 1:1 fashion, 5 withdrew from the study or had surgery canceled, and 121 completed the bowel diary.

The mean time to first bowel movement after surgery was similar in the two groups: 3.3 days in the bowel prep group and 3.2 days in the control group. The groups were also similar with regard to pain, fecal urgency, and stool transit times on the day of the first postoperative bowel movement. The use of antiemetics postoperatively was similar as well (48% and 55% in the bowel prep and no-prep groups, respectively.)

Most of the 121 women – across both groups – used at least one laxative postoperatively, mainly osmotic laxatives. Women who had not received bowel preparation were more likely, however, to report daily fiber use.

"Bowel preparation ... doesn’t appear to affect the return of bowel function and other bowel symptoms postoperatively," Dr. Ballard said. Moreover, "the lack of bowel preparation doesn’t seem to impact painful defecation symptoms, and most women use some type of laxative."

The study’s exclusion criteria included colorectal cancer, inflammatory bowel disease, a history of bowel resection, neurological disorders, and symptoms of colonic inertia (fewer than three bowel movements per week). The decision to exclude patients with significant preoperative constipation was made in order to "decrease the risk of bowel dysfunction and was important for our primary outcomes," Dr. Ballard explained. "But there actually were not that many women excluded."

Dr. Ballard reported that she had no disclosures. Two of her five coinvestigators reported various relationships with St. Jude Medical and Pelvalon.

WASHINGTON – Bowel preparation for vaginal reconstructive surgery does not affect postoperative bowel function and bowel symptoms one way or the other, according to a secondary analysis of a single-blind randomized trial examining various effects of mechanical bowel preparation.

In a primary analysis published earlier this year, investigators found no benefit to mechanical bowel preparation with regard to the operative field quality. They also found that patients who were randomized not to receive bowel preparation were more satisfied and had fewer abdominal symptoms than those who received the intervention – a clear-liquid diet and enemas (Obstet. Gynecol. 2014;123:232-8).

The new analysis, reported at the scientific meetings of the American Urogynecologic Society and the International Urogynecological Association, looked more closely at postoperative bowel habits after vaginal reconstructive surgery.

"As surgical intervention for pelvic organ prolapse increases, so does our need for knowledge of [best] perioperative management practices," said Dr. Alicia C. Ballard of the division of urogynecology and pelvic reconstructive surgery at the University of Alabama at Birmingham, where the study was conducted.

"Concerns about painful defecation and GI symptoms such as nausea and vomiting are significant concerns for women undergoing surgery," she said.

Women may be predisposed to postsurgical constipation as a result of preoperative bowel preparation (including diet), the lasting effects of anesthesia, the use of narcotics, and the surgery itself. Prior research has shown, moreover, that constipation and incomplete bowel evacuation are not uncommon preoperatively in women with pelvic organ prolapse, she noted.

The study randomized 150 women scheduled to undergo vaginal prolapse surgery with, at a minimum, a planned apical suspension and posterior compartment repair. Surgeries included other prolapse and incontinence procedures.

Women randomized to the bowel preparation group were instructed to have a clear-liquid diet and to self-administer two saline enemas in the late afternoon of the day before surgery.

Those who were randomized to receive no intervention were allowed to have a regular diet. Women in both groups were instructed to eat nothing after midnight on the day of surgery.

All study participants were instructed to complete a bowel diary for 7 days preoperatively and 14 days postoperatively. Those who completed the preoperative diary and 10 of 14 days of the postoperative diary were included in the analysis.

Of the 150 women randomized at the preoperative visit in a 1:1 fashion, 5 withdrew from the study or had surgery canceled, and 121 completed the bowel diary.

The mean time to first bowel movement after surgery was similar in the two groups: 3.3 days in the bowel prep group and 3.2 days in the control group. The groups were also similar with regard to pain, fecal urgency, and stool transit times on the day of the first postoperative bowel movement. The use of antiemetics postoperatively was similar as well (48% and 55% in the bowel prep and no-prep groups, respectively.)

Most of the 121 women – across both groups – used at least one laxative postoperatively, mainly osmotic laxatives. Women who had not received bowel preparation were more likely, however, to report daily fiber use.

"Bowel preparation ... doesn’t appear to affect the return of bowel function and other bowel symptoms postoperatively," Dr. Ballard said. Moreover, "the lack of bowel preparation doesn’t seem to impact painful defecation symptoms, and most women use some type of laxative."

The study’s exclusion criteria included colorectal cancer, inflammatory bowel disease, a history of bowel resection, neurological disorders, and symptoms of colonic inertia (fewer than three bowel movements per week). The decision to exclude patients with significant preoperative constipation was made in order to "decrease the risk of bowel dysfunction and was important for our primary outcomes," Dr. Ballard explained. "But there actually were not that many women excluded."

Dr. Ballard reported that she had no disclosures. Two of her five coinvestigators reported various relationships with St. Jude Medical and Pelvalon.

WASHINGTON – Bowel preparation for vaginal reconstructive surgery does not affect postoperative bowel function and bowel symptoms one way or the other, according to a secondary analysis of a single-blind randomized trial examining various effects of mechanical bowel preparation.

In a primary analysis published earlier this year, investigators found no benefit to mechanical bowel preparation with regard to the operative field quality. They also found that patients who were randomized not to receive bowel preparation were more satisfied and had fewer abdominal symptoms than those who received the intervention – a clear-liquid diet and enemas (Obstet. Gynecol. 2014;123:232-8).

The new analysis, reported at the scientific meetings of the American Urogynecologic Society and the International Urogynecological Association, looked more closely at postoperative bowel habits after vaginal reconstructive surgery.

"As surgical intervention for pelvic organ prolapse increases, so does our need for knowledge of [best] perioperative management practices," said Dr. Alicia C. Ballard of the division of urogynecology and pelvic reconstructive surgery at the University of Alabama at Birmingham, where the study was conducted.

"Concerns about painful defecation and GI symptoms such as nausea and vomiting are significant concerns for women undergoing surgery," she said.

Women may be predisposed to postsurgical constipation as a result of preoperative bowel preparation (including diet), the lasting effects of anesthesia, the use of narcotics, and the surgery itself. Prior research has shown, moreover, that constipation and incomplete bowel evacuation are not uncommon preoperatively in women with pelvic organ prolapse, she noted.

The study randomized 150 women scheduled to undergo vaginal prolapse surgery with, at a minimum, a planned apical suspension and posterior compartment repair. Surgeries included other prolapse and incontinence procedures.

Women randomized to the bowel preparation group were instructed to have a clear-liquid diet and to self-administer two saline enemas in the late afternoon of the day before surgery.

Those who were randomized to receive no intervention were allowed to have a regular diet. Women in both groups were instructed to eat nothing after midnight on the day of surgery.

All study participants were instructed to complete a bowel diary for 7 days preoperatively and 14 days postoperatively. Those who completed the preoperative diary and 10 of 14 days of the postoperative diary were included in the analysis.

Of the 150 women randomized at the preoperative visit in a 1:1 fashion, 5 withdrew from the study or had surgery canceled, and 121 completed the bowel diary.

The mean time to first bowel movement after surgery was similar in the two groups: 3.3 days in the bowel prep group and 3.2 days in the control group. The groups were also similar with regard to pain, fecal urgency, and stool transit times on the day of the first postoperative bowel movement. The use of antiemetics postoperatively was similar as well (48% and 55% in the bowel prep and no-prep groups, respectively.)

Most of the 121 women – across both groups – used at least one laxative postoperatively, mainly osmotic laxatives. Women who had not received bowel preparation were more likely, however, to report daily fiber use.

"Bowel preparation ... doesn’t appear to affect the return of bowel function and other bowel symptoms postoperatively," Dr. Ballard said. Moreover, "the lack of bowel preparation doesn’t seem to impact painful defecation symptoms, and most women use some type of laxative."

The study’s exclusion criteria included colorectal cancer, inflammatory bowel disease, a history of bowel resection, neurological disorders, and symptoms of colonic inertia (fewer than three bowel movements per week). The decision to exclude patients with significant preoperative constipation was made in order to "decrease the risk of bowel dysfunction and was important for our primary outcomes," Dr. Ballard explained. "But there actually were not that many women excluded."

Dr. Ballard reported that she had no disclosures. Two of her five coinvestigators reported various relationships with St. Jude Medical and Pelvalon.

Ethicon has initiated a worldwide withdrawal of the company’s morcellation devices because of the uncertainty over the risk-benefit profile of these devices when used in hysterectomies and myomectomies for women with fibroids, the company announced in a letter on July 30.

The withdrawal – which is voluntary – is an expansion of the company’s suspension of worldwide sales of these devices in April, following the Food and Drug Administration (FDA) announcement recommending that the use of power morcellation during laparoscopic hysterectomy or myomectomy to remove uterine fibroids should be "discouraged," because the procedure could spread cancerous tissue in women with an unsuspected sarcoma.

In its letter, Ethicon stated that the company believes that its morcellation devices "perform as intended and there are patients who can benefit from procedures using laparoscopic power morcellators."

However, the letter adds that "the risk-benefit assessment associated with the use of these devices in hysterectomy and myomectomy procedures remains uncertain," and the company believes that market withdrawal "is the appropriate course of action at this time until further medical guidelines are established and/or new technologies are developed to mitigate the risk."

The Ethicon withdrawal was announced less than 3 weeks after the FDA held a 2-day meeting of its Obstetrics and Gynecology Devices Advisory Panel to discuss the benefits, risks, and clinical role of laparoscopic power morcellators (LPMs) in the treatment of women with uterine fibroids.

Panelists also discussed strategies that might reduce the risks of morcellation disseminating cancerous tissue into the pelvis and abdomen of women with an unsuspected uterine sarcoma or leiomyosarcoma (LMS). Two panelists said that LPMs should not be used for gynecologic indications until better data are available, and during the open public hearing, Dr. Hooman Nourchashm, a cardiothoracic surgeon, reiterated his call for a worldwide moratorium on all gynecological tissue morcellation devices and on the practice of intracorporeal uterine morcellation during minimally invasive hysterectomy. He and his wife, anesthesiologist Dr. Amy Reed, who was diagnosed in 2013 with stage IV LMS after undergoing a hysterectomy with morcellation at the age of 40 for what was thought to be benign fibroids, are leading a campaign calling for the ban.

The Ethicon letter states that the discussion during the meeting "demonstrated the complexity of this issue, particularly with respect to the difficulty for medical professionals to preoperatively diagnose some malignancies, such as leiomyosarcoma ... [and] the risk of disseminating unsuspected malignant tissue while using power morcellation devices," as well as methods to mitigate this risk.

But to date, Ethicon, a Johnson & Johnson company, is the only manufacturer of morcellation devices used in gynecology to suspend and withdraw its products. There are five other manufacturers or distributors of LPMs with gynecologic indications that have been marketed in the past year, according to the FDA.

Dr. David Jaspan, chairman of the department of obstetrics and gynecology at Einstein Medical Center, Philadelphia, said in an interview that he views the Ethicon move to withdraw all morcellation devices as a business decision. This "may be the first domino to fall," and whether competing manufacturers of morcellation devices also decide to withdraw their products or choose an alternative path "remains to be seen."

At the Einstein health care network in Philadelphia, there is currently a moratorium prohibiting the use of power morcellation in gynecologic surgery, while a standard acceptable counseling form is being developed. Dr. Jaspan is working with robotic and minimally invasive surgeons "to create a document that we feel will provide patients with transparency, alternatives, and choice," he noted.

As a result of the FDA’s safety announcement, there has been an increase in open procedures for fibroids in patients who would have been "excellent candidates" for a robotic procedure; did not have a sarcoma; and would have avoided a prolonged length of stay, time away from work, delay in activities of daily living, more blood loss, and pain, he said.

But the FDA estimates that among women who undergo a hysterectomy or myomectomy for a presumed fibroid, about 1 in 350 has a uterine sarcoma, and about 1 in 500 has an LMS. Dr. Jaspan is among those who believe this is an overestimate.

Dr. Jaspan had no disclosures.

Ethicon can be contacted at 877-384-4266 for more information. Adverse events related to LPMs or other medical devices should be reported to the FDA at 800-332-1088 or here.

emechcatie@frontlinemedcom.com

Ethicon has initiated a worldwide withdrawal of the company’s morcellation devices because of the uncertainty over the risk-benefit profile of these devices when used in hysterectomies and myomectomies for women with fibroids, the company announced in a letter on July 30.

The withdrawal – which is voluntary – is an expansion of the company’s suspension of worldwide sales of these devices in April, following the Food and Drug Administration (FDA) announcement recommending that the use of power morcellation during laparoscopic hysterectomy or myomectomy to remove uterine fibroids should be "discouraged," because the procedure could spread cancerous tissue in women with an unsuspected sarcoma.

In its letter, Ethicon stated that the company believes that its morcellation devices "perform as intended and there are patients who can benefit from procedures using laparoscopic power morcellators."

However, the letter adds that "the risk-benefit assessment associated with the use of these devices in hysterectomy and myomectomy procedures remains uncertain," and the company believes that market withdrawal "is the appropriate course of action at this time until further medical guidelines are established and/or new technologies are developed to mitigate the risk."

The Ethicon withdrawal was announced less than 3 weeks after the FDA held a 2-day meeting of its Obstetrics and Gynecology Devices Advisory Panel to discuss the benefits, risks, and clinical role of laparoscopic power morcellators (LPMs) in the treatment of women with uterine fibroids.

Panelists also discussed strategies that might reduce the risks of morcellation disseminating cancerous tissue into the pelvis and abdomen of women with an unsuspected uterine sarcoma or leiomyosarcoma (LMS). Two panelists said that LPMs should not be used for gynecologic indications until better data are available, and during the open public hearing, Dr. Hooman Nourchashm, a cardiothoracic surgeon, reiterated his call for a worldwide moratorium on all gynecological tissue morcellation devices and on the practice of intracorporeal uterine morcellation during minimally invasive hysterectomy. He and his wife, anesthesiologist Dr. Amy Reed, who was diagnosed in 2013 with stage IV LMS after undergoing a hysterectomy with morcellation at the age of 40 for what was thought to be benign fibroids, are leading a campaign calling for the ban.

The Ethicon letter states that the discussion during the meeting "demonstrated the complexity of this issue, particularly with respect to the difficulty for medical professionals to preoperatively diagnose some malignancies, such as leiomyosarcoma ... [and] the risk of disseminating unsuspected malignant tissue while using power morcellation devices," as well as methods to mitigate this risk.

But to date, Ethicon, a Johnson & Johnson company, is the only manufacturer of morcellation devices used in gynecology to suspend and withdraw its products. There are five other manufacturers or distributors of LPMs with gynecologic indications that have been marketed in the past year, according to the FDA.

Dr. David Jaspan, chairman of the department of obstetrics and gynecology at Einstein Medical Center, Philadelphia, said in an interview that he views the Ethicon move to withdraw all morcellation devices as a business decision. This "may be the first domino to fall," and whether competing manufacturers of morcellation devices also decide to withdraw their products or choose an alternative path "remains to be seen."

At the Einstein health care network in Philadelphia, there is currently a moratorium prohibiting the use of power morcellation in gynecologic surgery, while a standard acceptable counseling form is being developed. Dr. Jaspan is working with robotic and minimally invasive surgeons "to create a document that we feel will provide patients with transparency, alternatives, and choice," he noted.

As a result of the FDA’s safety announcement, there has been an increase in open procedures for fibroids in patients who would have been "excellent candidates" for a robotic procedure; did not have a sarcoma; and would have avoided a prolonged length of stay, time away from work, delay in activities of daily living, more blood loss, and pain, he said.

But the FDA estimates that among women who undergo a hysterectomy or myomectomy for a presumed fibroid, about 1 in 350 has a uterine sarcoma, and about 1 in 500 has an LMS. Dr. Jaspan is among those who believe this is an overestimate.

Dr. Jaspan had no disclosures.

Ethicon can be contacted at 877-384-4266 for more information. Adverse events related to LPMs or other medical devices should be reported to the FDA at 800-332-1088 or here.

emechcatie@frontlinemedcom.com

Ethicon has initiated a worldwide withdrawal of the company’s morcellation devices because of the uncertainty over the risk-benefit profile of these devices when used in hysterectomies and myomectomies for women with fibroids, the company announced in a letter on July 30.

The withdrawal – which is voluntary – is an expansion of the company’s suspension of worldwide sales of these devices in April, following the Food and Drug Administration (FDA) announcement recommending that the use of power morcellation during laparoscopic hysterectomy or myomectomy to remove uterine fibroids should be "discouraged," because the procedure could spread cancerous tissue in women with an unsuspected sarcoma.

In its letter, Ethicon stated that the company believes that its morcellation devices "perform as intended and there are patients who can benefit from procedures using laparoscopic power morcellators."

However, the letter adds that "the risk-benefit assessment associated with the use of these devices in hysterectomy and myomectomy procedures remains uncertain," and the company believes that market withdrawal "is the appropriate course of action at this time until further medical guidelines are established and/or new technologies are developed to mitigate the risk."

The Ethicon withdrawal was announced less than 3 weeks after the FDA held a 2-day meeting of its Obstetrics and Gynecology Devices Advisory Panel to discuss the benefits, risks, and clinical role of laparoscopic power morcellators (LPMs) in the treatment of women with uterine fibroids.

Panelists also discussed strategies that might reduce the risks of morcellation disseminating cancerous tissue into the pelvis and abdomen of women with an unsuspected uterine sarcoma or leiomyosarcoma (LMS). Two panelists said that LPMs should not be used for gynecologic indications until better data are available, and during the open public hearing, Dr. Hooman Nourchashm, a cardiothoracic surgeon, reiterated his call for a worldwide moratorium on all gynecological tissue morcellation devices and on the practice of intracorporeal uterine morcellation during minimally invasive hysterectomy. He and his wife, anesthesiologist Dr. Amy Reed, who was diagnosed in 2013 with stage IV LMS after undergoing a hysterectomy with morcellation at the age of 40 for what was thought to be benign fibroids, are leading a campaign calling for the ban.

The Ethicon letter states that the discussion during the meeting "demonstrated the complexity of this issue, particularly with respect to the difficulty for medical professionals to preoperatively diagnose some malignancies, such as leiomyosarcoma ... [and] the risk of disseminating unsuspected malignant tissue while using power morcellation devices," as well as methods to mitigate this risk.

But to date, Ethicon, a Johnson & Johnson company, is the only manufacturer of morcellation devices used in gynecology to suspend and withdraw its products. There are five other manufacturers or distributors of LPMs with gynecologic indications that have been marketed in the past year, according to the FDA.

Dr. David Jaspan, chairman of the department of obstetrics and gynecology at Einstein Medical Center, Philadelphia, said in an interview that he views the Ethicon move to withdraw all morcellation devices as a business decision. This "may be the first domino to fall," and whether competing manufacturers of morcellation devices also decide to withdraw their products or choose an alternative path "remains to be seen."

At the Einstein health care network in Philadelphia, there is currently a moratorium prohibiting the use of power morcellation in gynecologic surgery, while a standard acceptable counseling form is being developed. Dr. Jaspan is working with robotic and minimally invasive surgeons "to create a document that we feel will provide patients with transparency, alternatives, and choice," he noted.

As a result of the FDA’s safety announcement, there has been an increase in open procedures for fibroids in patients who would have been "excellent candidates" for a robotic procedure; did not have a sarcoma; and would have avoided a prolonged length of stay, time away from work, delay in activities of daily living, more blood loss, and pain, he said.

But the FDA estimates that among women who undergo a hysterectomy or myomectomy for a presumed fibroid, about 1 in 350 has a uterine sarcoma, and about 1 in 500 has an LMS. Dr. Jaspan is among those who believe this is an overestimate.

Dr. Jaspan had no disclosures.

Ethicon can be contacted at 877-384-4266 for more information. Adverse events related to LPMs or other medical devices should be reported to the FDA at 800-332-1088 or here.

emechcatie@frontlinemedcom.com

WASHINGTON – Women are not seeking care for even moderate to severe urinary incontinence because they have a fear of treatment and lack knowledge of the etiology of the condition and available treatment options, according to a qualitative focus group study at Kaiser Permanente Orange County (Calif.).

Embarrassment is another barrier. So are physicians themselves, said Dr. Jennifer K. Lee, a urogynecologist at Kaiser in Anaheim, Calif., who reported the findings at the annual meeting of the American Urogynecologic Society.

"Providers were mentioned (in the focus groups) to be barriers," Dr. Lee said. "Patients were either dismissed, or they were given misinformation."

By 2050, an estimated 50 million Americans will have urinary incontinence. Previous research has shown, however, that less than 50% of women with moderate incontinence seek care.

The focus group study involved 19 women – 11 who had not sought care but were found after recruitment to have moderate to severe incontinence by the Sandvik severity index, and 8 who had previous treatment or had been evaluated for urinary incontinence.

A moderator led discussions among small groups of these women, all of whom were fluent in English and most of whom (90%) had a college education or higher. The participants were of varying ethnicities, including Caucasian, Hispanic, and Asian.

A fear of medical or surgical treatment, including medication side effects and recovery time for surgery, was one of the themes to emerge. Women also said they felt embarrassed and were therefore not likely to raise the issue, particularly with time constraints in their medical visits.

There was a prevailing idea that urinary incontinence is a normal part of aging or childbearing, or that it is hereditary, and that other health issues take priority. Physicians, moreover, did not ask about the issue, and in cases in which it was mentioned, physicians were dismissive or gave misinformation, the study showed.

Dr. Lee said the barriers are significant, and that "there’s a lot of work to be done" to facilitate communication and change practices.

Leaders at Kaiser Permanente Orange County, Anaheim, Calif., plan to give physicians question prompts to incorporate into routine and primary care visits, she noted during a press conference at the meeting. "We also want to work on educational tools for the public," she said.

"There are urinary incontinence questions [for] the Medicare wellness visit, but these are for women over 65," she said. "There certainly are plenty of women under 65 who have incontinence."

Food and Drug Administration warnings about complications associated with transvaginal placement of surgical mesh did not come up in the focus group discussions, but Dr. Lee said that in her practice she has seen this controversy feed patients’ fear of incontinence and its treatment.

Study participants were recruited through e-mail research announcements and flyers, as well as more actively through the offices of urogynecology providers.

Dr. Lee said she had no disclosures to report. Her coauthors and research colleagues at the University of California, Irvine, reported numerous disclosures ranging from speakers’ bureau participation and consulting fees at Hospira and Cadence Pharmaceuticals to consultant positions with Medtronic and Boston Scientific.

WASHINGTON – Women are not seeking care for even moderate to severe urinary incontinence because they have a fear of treatment and lack knowledge of the etiology of the condition and available treatment options, according to a qualitative focus group study at Kaiser Permanente Orange County (Calif.).

Embarrassment is another barrier. So are physicians themselves, said Dr. Jennifer K. Lee, a urogynecologist at Kaiser in Anaheim, Calif., who reported the findings at the annual meeting of the American Urogynecologic Society.

"Providers were mentioned (in the focus groups) to be barriers," Dr. Lee said. "Patients were either dismissed, or they were given misinformation."

By 2050, an estimated 50 million Americans will have urinary incontinence. Previous research has shown, however, that less than 50% of women with moderate incontinence seek care.

The focus group study involved 19 women – 11 who had not sought care but were found after recruitment to have moderate to severe incontinence by the Sandvik severity index, and 8 who had previous treatment or had been evaluated for urinary incontinence.

A moderator led discussions among small groups of these women, all of whom were fluent in English and most of whom (90%) had a college education or higher. The participants were of varying ethnicities, including Caucasian, Hispanic, and Asian.

A fear of medical or surgical treatment, including medication side effects and recovery time for surgery, was one of the themes to emerge. Women also said they felt embarrassed and were therefore not likely to raise the issue, particularly with time constraints in their medical visits.

There was a prevailing idea that urinary incontinence is a normal part of aging or childbearing, or that it is hereditary, and that other health issues take priority. Physicians, moreover, did not ask about the issue, and in cases in which it was mentioned, physicians were dismissive or gave misinformation, the study showed.

Dr. Lee said the barriers are significant, and that "there’s a lot of work to be done" to facilitate communication and change practices.

Leaders at Kaiser Permanente Orange County, Anaheim, Calif., plan to give physicians question prompts to incorporate into routine and primary care visits, she noted during a press conference at the meeting. "We also want to work on educational tools for the public," she said.

"There are urinary incontinence questions [for] the Medicare wellness visit, but these are for women over 65," she said. "There certainly are plenty of women under 65 who have incontinence."

Food and Drug Administration warnings about complications associated with transvaginal placement of surgical mesh did not come up in the focus group discussions, but Dr. Lee said that in her practice she has seen this controversy feed patients’ fear of incontinence and its treatment.

Study participants were recruited through e-mail research announcements and flyers, as well as more actively through the offices of urogynecology providers.

Dr. Lee said she had no disclosures to report. Her coauthors and research colleagues at the University of California, Irvine, reported numerous disclosures ranging from speakers’ bureau participation and consulting fees at Hospira and Cadence Pharmaceuticals to consultant positions with Medtronic and Boston Scientific.

WASHINGTON – Women are not seeking care for even moderate to severe urinary incontinence because they have a fear of treatment and lack knowledge of the etiology of the condition and available treatment options, according to a qualitative focus group study at Kaiser Permanente Orange County (Calif.).

Embarrassment is another barrier. So are physicians themselves, said Dr. Jennifer K. Lee, a urogynecologist at Kaiser in Anaheim, Calif., who reported the findings at the annual meeting of the American Urogynecologic Society.

"Providers were mentioned (in the focus groups) to be barriers," Dr. Lee said. "Patients were either dismissed, or they were given misinformation."

By 2050, an estimated 50 million Americans will have urinary incontinence. Previous research has shown, however, that less than 50% of women with moderate incontinence seek care.

The focus group study involved 19 women – 11 who had not sought care but were found after recruitment to have moderate to severe incontinence by the Sandvik severity index, and 8 who had previous treatment or had been evaluated for urinary incontinence.

A moderator led discussions among small groups of these women, all of whom were fluent in English and most of whom (90%) had a college education or higher. The participants were of varying ethnicities, including Caucasian, Hispanic, and Asian.

A fear of medical or surgical treatment, including medication side effects and recovery time for surgery, was one of the themes to emerge. Women also said they felt embarrassed and were therefore not likely to raise the issue, particularly with time constraints in their medical visits.

There was a prevailing idea that urinary incontinence is a normal part of aging or childbearing, or that it is hereditary, and that other health issues take priority. Physicians, moreover, did not ask about the issue, and in cases in which it was mentioned, physicians were dismissive or gave misinformation, the study showed.

Dr. Lee said the barriers are significant, and that "there’s a lot of work to be done" to facilitate communication and change practices.

Leaders at Kaiser Permanente Orange County, Anaheim, Calif., plan to give physicians question prompts to incorporate into routine and primary care visits, she noted during a press conference at the meeting. "We also want to work on educational tools for the public," she said.

"There are urinary incontinence questions [for] the Medicare wellness visit, but these are for women over 65," she said. "There certainly are plenty of women under 65 who have incontinence."

Food and Drug Administration warnings about complications associated with transvaginal placement of surgical mesh did not come up in the focus group discussions, but Dr. Lee said that in her practice she has seen this controversy feed patients’ fear of incontinence and its treatment.

Study participants were recruited through e-mail research announcements and flyers, as well as more actively through the offices of urogynecology providers.

Dr. Lee said she had no disclosures to report. Her coauthors and research colleagues at the University of California, Irvine, reported numerous disclosures ranging from speakers’ bureau participation and consulting fees at Hospira and Cadence Pharmaceuticals to consultant positions with Medtronic and Boston Scientific.

WASHINGTON – Obese women experienced significant improvements in sexual function over 6-24 months after bariatric surgery in a multistudy review, indicating that this outcome should be listed among the possible benefits of surgery in this patient population, Dr. Kalaivani Ramalingam said at a joint annual meeting of the American Urogynecologic Society.

In a review of studies published between 1996 and 2013, Dr. Ramalingam of the department of gynecology at Kingston Hospital, Kingston upon Thames, England, and her associates identified five original studies of 254 obese women undergoing bariatric surgery that reported Female Sexual Function Index (FSFI) scores before and after surgery. Studies of nonsurgical weight loss treatments and those that included both men and women were not included. The FSFI evaluates sexual function in six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain.

Patients in the studies had statistically significant reductions in body mass index over 6-24 months of follow-up (P = .001). In one of the five studies, which enrolled 36 patients, FSFI scores did not improve after surgery.

But in the remaining four studies, there were statistically significant improvements in the overall FSFI scores after surgery (P = .003), Dr. Ramalingam said. In addition, statistically significant improvements in all domains of the score were observed after surgery: increased desire (P = .005), arousal (P = .001), lubrication (P = .003), satisfaction (P = .012) and orgasm (P =.003) – and a decrease in the levels of pain during intercourse (P = .014).

She noted that in one of the five studies, sexual function improved in women with pelvic floor dysfunction and that further studies in this specific group of patients are needed to evaluate the effect of surgery among obese women who are undergoing bariatric surgery and have pelvic floor dysfunction.

An estimated 51% of female bariatric surgery patients report sexual dysfunction, she said.

Dr. Ramalingam and one of her coauthors had no relevant disclosures. The third author disclosed being a speaker for and receiving honoraria from Pfizer, Astellas, and Shire; and serving on an advisory committee for Allergan.

emechcatie@frontlinemedcom.com

WASHINGTON – Obese women experienced significant improvements in sexual function over 6-24 months after bariatric surgery in a multistudy review, indicating that this outcome should be listed among the possible benefits of surgery in this patient population, Dr. Kalaivani Ramalingam said at a joint annual meeting of the American Urogynecologic Society.

In a review of studies published between 1996 and 2013, Dr. Ramalingam of the department of gynecology at Kingston Hospital, Kingston upon Thames, England, and her associates identified five original studies of 254 obese women undergoing bariatric surgery that reported Female Sexual Function Index (FSFI) scores before and after surgery. Studies of nonsurgical weight loss treatments and those that included both men and women were not included. The FSFI evaluates sexual function in six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain.

Patients in the studies had statistically significant reductions in body mass index over 6-24 months of follow-up (P = .001). In one of the five studies, which enrolled 36 patients, FSFI scores did not improve after surgery.

But in the remaining four studies, there were statistically significant improvements in the overall FSFI scores after surgery (P = .003), Dr. Ramalingam said. In addition, statistically significant improvements in all domains of the score were observed after surgery: increased desire (P = .005), arousal (P = .001), lubrication (P = .003), satisfaction (P = .012) and orgasm (P =.003) – and a decrease in the levels of pain during intercourse (P = .014).

She noted that in one of the five studies, sexual function improved in women with pelvic floor dysfunction and that further studies in this specific group of patients are needed to evaluate the effect of surgery among obese women who are undergoing bariatric surgery and have pelvic floor dysfunction.

An estimated 51% of female bariatric surgery patients report sexual dysfunction, she said.

Dr. Ramalingam and one of her coauthors had no relevant disclosures. The third author disclosed being a speaker for and receiving honoraria from Pfizer, Astellas, and Shire; and serving on an advisory committee for Allergan.

emechcatie@frontlinemedcom.com

WASHINGTON – Obese women experienced significant improvements in sexual function over 6-24 months after bariatric surgery in a multistudy review, indicating that this outcome should be listed among the possible benefits of surgery in this patient population, Dr. Kalaivani Ramalingam said at a joint annual meeting of the American Urogynecologic Society.

In a review of studies published between 1996 and 2013, Dr. Ramalingam of the department of gynecology at Kingston Hospital, Kingston upon Thames, England, and her associates identified five original studies of 254 obese women undergoing bariatric surgery that reported Female Sexual Function Index (FSFI) scores before and after surgery. Studies of nonsurgical weight loss treatments and those that included both men and women were not included. The FSFI evaluates sexual function in six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain.

Patients in the studies had statistically significant reductions in body mass index over 6-24 months of follow-up (P = .001). In one of the five studies, which enrolled 36 patients, FSFI scores did not improve after surgery.

But in the remaining four studies, there were statistically significant improvements in the overall FSFI scores after surgery (P = .003), Dr. Ramalingam said. In addition, statistically significant improvements in all domains of the score were observed after surgery: increased desire (P = .005), arousal (P = .001), lubrication (P = .003), satisfaction (P = .012) and orgasm (P =.003) – and a decrease in the levels of pain during intercourse (P = .014).

She noted that in one of the five studies, sexual function improved in women with pelvic floor dysfunction and that further studies in this specific group of patients are needed to evaluate the effect of surgery among obese women who are undergoing bariatric surgery and have pelvic floor dysfunction.

An estimated 51% of female bariatric surgery patients report sexual dysfunction, she said.

Dr. Ramalingam and one of her coauthors had no relevant disclosures. The third author disclosed being a speaker for and receiving honoraria from Pfizer, Astellas, and Shire; and serving on an advisory committee for Allergan.

emechcatie@frontlinemedcom.com