Charles W. Nager, MD

In their review, Rachaneni and Latthe included randomized controlled trials (RCTs) comparing surgical outcomes in women investigated by urodynamics and women who had office evaluation only. Three RCTs met their a priori criteria of women with pure stress incontinence or stress-predominant mixed urinary incontinence, with outcomes describing cure or improvement of stress urinary incontinence (SUI). There were no statistical differences in the risk ratios of subjective cure, objective cure, voiding dysfunction, or urinary urgency between the 2 groups. Rachaneni and Latthe appropriately concluded that: “In women undergoing primary surgery for SUI or stress-predominant mixed urinary incontinence without voiding difficulties, urodynamics does not improve outcomes—as long as the women undergo careful office evaluation.”

Thorough evaluation is critical
It cannot be emphasized strongly enough that the mere presence of symptoms of SUI is insufficient justification for surgery. Providers should demonstrate SUI during office evaluation before operating on someone without urodynamics. The addition of a full-bladder standing stress test usually is sufficient to demonstrate incontinence in women with bothersome SUI.

National professional societies agree on what is involved in office evaluation. In June 2014, the American College of Obstetricians and Gynecologists and the American Urogynecologic Society published a joint committee opinion on evaluation of uncomplicated SUI in women before surgical treatment.¹ The committee opinion states¹:

Although the most recent Cochrane review found no evidence about urodynamic use in men, children, and people with neurologic disease and noted that large definitive trials are needed in which people are randomly allocated to urodynamics or not,² most experts believe, and this review confirms, that the issue has been settled for preoperative urodynamics in women with uncomplicated SUI before surgery.

What this evidence means for practic
It is safe to proceed to surgery for SUI without urodynamic testing in women who meet all the following criteria: no previous surgery, no prolapse beyond the introitus, presence of predominant SUI complaints, demonstration of stress incontinence on cough stress testing, normal postvoid residual, mobile urethra, and normal urinalysis.
— Charles W. Nager, MD

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

In their review, Rachaneni and Latthe included randomized controlled trials (RCTs) comparing surgical outcomes in women investigated by urodynamics and women who had office evaluation only. Three RCTs met their a priori criteria of women with pure stress incontinence or stress-predominant mixed urinary incontinence, with outcomes describing cure or improvement of stress urinary incontinence (SUI). There were no statistical differences in the risk ratios of subjective cure, objective cure, voiding dysfunction, or urinary urgency between the 2 groups. Rachaneni and Latthe appropriately concluded that: “In women undergoing primary surgery for SUI or stress-predominant mixed urinary incontinence without voiding difficulties, urodynamics does not improve outcomes—as long as the women undergo careful office evaluation.”

Thorough evaluation is critical
It cannot be emphasized strongly enough that the mere presence of symptoms of SUI is insufficient justification for surgery. Providers should demonstrate SUI during office evaluation before operating on someone without urodynamics. The addition of a full-bladder standing stress test usually is sufficient to demonstrate incontinence in women with bothersome SUI.

National professional societies agree on what is involved in office evaluation. In June 2014, the American College of Obstetricians and Gynecologists and the American Urogynecologic Society published a joint committee opinion on evaluation of uncomplicated SUI in women before surgical treatment.¹ The committee opinion states¹:

Although the most recent Cochrane review found no evidence about urodynamic use in men, children, and people with neurologic disease and noted that large definitive trials are needed in which people are randomly allocated to urodynamics or not,² most experts believe, and this review confirms, that the issue has been settled for preoperative urodynamics in women with uncomplicated SUI before surgery.

What this evidence means for practic
It is safe to proceed to surgery for SUI without urodynamic testing in women who meet all the following criteria: no previous surgery, no prolapse beyond the introitus, presence of predominant SUI complaints, demonstration of stress incontinence on cough stress testing, normal postvoid residual, mobile urethra, and normal urinalysis.
— Charles W. Nager, MD

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

In their review, Rachaneni and Latthe included randomized controlled trials (RCTs) comparing surgical outcomes in women investigated by urodynamics and women who had office evaluation only. Three RCTs met their a priori criteria of women with pure stress incontinence or stress-predominant mixed urinary incontinence, with outcomes describing cure or improvement of stress urinary incontinence (SUI). There were no statistical differences in the risk ratios of subjective cure, objective cure, voiding dysfunction, or urinary urgency between the 2 groups. Rachaneni and Latthe appropriately concluded that: “In women undergoing primary surgery for SUI or stress-predominant mixed urinary incontinence without voiding difficulties, urodynamics does not improve outcomes—as long as the women undergo careful office evaluation.”

Thorough evaluation is critical
It cannot be emphasized strongly enough that the mere presence of symptoms of SUI is insufficient justification for surgery. Providers should demonstrate SUI during office evaluation before operating on someone without urodynamics. The addition of a full-bladder standing stress test usually is sufficient to demonstrate incontinence in women with bothersome SUI.

National professional societies agree on what is involved in office evaluation. In June 2014, the American College of Obstetricians and Gynecologists and the American Urogynecologic Society published a joint committee opinion on evaluation of uncomplicated SUI in women before surgical treatment.¹ The committee opinion states¹:

Although the most recent Cochrane review found no evidence about urodynamic use in men, children, and people with neurologic disease and noted that large definitive trials are needed in which people are randomly allocated to urodynamics or not,² most experts believe, and this review confirms, that the issue has been settled for preoperative urodynamics in women with uncomplicated SUI before surgery.

What this evidence means for practic
It is safe to proceed to surgery for SUI without urodynamic testing in women who meet all the following criteria: no previous surgery, no prolapse beyond the introitus, presence of predominant SUI complaints, demonstration of stress incontinence on cough stress testing, normal postvoid residual, mobile urethra, and normal urinalysis.
— Charles W. Nager, MD

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

The current surgical options for managing stress urinary incontinence (SUI) include:

These options—specifically MUS, which are the predominant SUI surgical procedure and the clear standard of care—remain in the surgeon’s armamentarium after the July 2011, FDA safety warning.¹

Confusion persists

A common misunderstanding is that full-length MUS were included in the FDA warning; however, the warning was about transvaginal mesh for prolapse and was titled, “Urogynecologic Surgical Mesh: Update on the Safety and Effectiveness of Vaginal Placement for Pelvic Organ Prolapse.”¹ In this document, it was explicitly stated: “The FDA continues to evaluate the effects of using surgical mesh for the treatment of SUI and will report about that usage at a later date.” In early 2012, when the FDA sent letters to industry for postmarketing approval study requests,² full-length MUS (but not single-incision mini-slings), were excluded from further study.

On page 24 of this issue, the technique for a pubovaginal sling is very well described by Drs. Karram and Zoorob in their article, “When and how to place an autologous rectus fascia pubovaginal sling.” There may be a place for this pubovaginal sling procedure for women with previous urethral surgery or radiation, but studies are needed to determine if repeat MUS or pubovaginal slings are the best procedure for recurrent incontinence. You should not get the impression that the current mesh controversy justifies abandoning the full-length MUS for a pubovaginal sling.

Unfortunately, television ads by law firms trawling for potential clients with any mesh in their vagina have created confusion among patients that synthetic MUS for incontinence is the same as transvaginal mesh for prolapse. In most clinical scenarios, rather than validating the patients’ concerns about the safety of synthetic mesh and performing a pubovaginal sling procedure, the most appropriate course of action is detailed, evidence-based patient education about MUS safety and efficacy to counter the patient’s misperceptions of safety concerns.

A bit of history on MUS

The first retropubic MUS was the tension-free vaginal tape (TVT) procedure published by Ulmsten in 1996.³ This minimally invasive outpatient procedure using a 1-cm wide strip of polypropylene mesh has revolutionized the management of SUI and has been the most studied surgical procedure in all of gynecology. A PubMed search of “tension- free vaginal tape” reveals more than 2,000 publications.

MUS vs pubovaginal slings. In a recent updated systematic review of 39 randomized controlled trials comparing different SUI procedures, midurethral slings and pubovaginal slings had similar cure rates. Pubovaginal slings, however, had more postoperative lower urinary tract symptoms and a higher reoperation rate.⁴

Pubovaginal slings require an 8-cm lower-abdominal incision, general or regional anesthesia, and hospitalization (usually). They also have higher risks of intraoperative bleeding and wound complications (including incisional hernias) than MUS. By contrast, MUS require 3 small 1-cm incisions and can be performed on an outpatient basis with local anesthesia and sedation. Postoperative recovery is significantly easier and shorter with MUS than with pubovaginal slings. Pubovaginal slings performed with human cadaveric material and porcine material have inferior outcomes to autologous material.⁵

Modifications to MUS included transobturator approaches, which have comparable efficacy to the retropubic approach.⁶ In this century, the full-length MUS procedures are the predominant SUI surgical procedure and the clear standard of care.

In a recent study involving 53 urologists and urogynecologists (of whom >90% were fellowship-trained), use of full-length MUS was the preferred procedure in 93% of primary stress incontinence surgical procedures.⁷ In fact, full-length MUS have been so successful and safe that extrapolation of a small ribbon of mesh under the midurethra to larger sheets of mesh for the entire vagina is what produced our current transvaginal mesh controversy. The vaginal erosion rates of 10% that have been seen with much larger pieces of transvaginal mesh are only 1% with MUS.⁸ Studies have not demonstrated common or significant vaginal pain or pain with intercourse after MUS.

Let’s educate our patients

In my clinical practice, I have found that educating patients about the safety and efficacy of synthetic MUS is extremely successful. I urge you to not replace on a widespread basis the most studied, safe, and successful treatment for SUI with a procedure that is considerably more invasive and complicated and can be more painful and require a longer recovery. We all must do our best to clear up the confusion created by misleading television advertisements by law firms. Full-length synthetic midurethral slings remain the current standard of care for stress incontinence surgery.

INSTANT POLL. How do you educate your patients on the use of surgical mesh? Click here

The current surgical options for managing stress urinary incontinence (SUI) include:

These options—specifically MUS, which are the predominant SUI surgical procedure and the clear standard of care—remain in the surgeon’s armamentarium after the July 2011, FDA safety warning.¹

Confusion persists

A common misunderstanding is that full-length MUS were included in the FDA warning; however, the warning was about transvaginal mesh for prolapse and was titled, “Urogynecologic Surgical Mesh: Update on the Safety and Effectiveness of Vaginal Placement for Pelvic Organ Prolapse.”¹ In this document, it was explicitly stated: “The FDA continues to evaluate the effects of using surgical mesh for the treatment of SUI and will report about that usage at a later date.” In early 2012, when the FDA sent letters to industry for postmarketing approval study requests,² full-length MUS (but not single-incision mini-slings), were excluded from further study.

On page 24 of this issue, the technique for a pubovaginal sling is very well described by Drs. Karram and Zoorob in their article, “When and how to place an autologous rectus fascia pubovaginal sling.” There may be a place for this pubovaginal sling procedure for women with previous urethral surgery or radiation, but studies are needed to determine if repeat MUS or pubovaginal slings are the best procedure for recurrent incontinence. You should not get the impression that the current mesh controversy justifies abandoning the full-length MUS for a pubovaginal sling.

Unfortunately, television ads by law firms trawling for potential clients with any mesh in their vagina have created confusion among patients that synthetic MUS for incontinence is the same as transvaginal mesh for prolapse. In most clinical scenarios, rather than validating the patients’ concerns about the safety of synthetic mesh and performing a pubovaginal sling procedure, the most appropriate course of action is detailed, evidence-based patient education about MUS safety and efficacy to counter the patient’s misperceptions of safety concerns.

A bit of history on MUS

The first retropubic MUS was the tension-free vaginal tape (TVT) procedure published by Ulmsten in 1996.³ This minimally invasive outpatient procedure using a 1-cm wide strip of polypropylene mesh has revolutionized the management of SUI and has been the most studied surgical procedure in all of gynecology. A PubMed search of “tension- free vaginal tape” reveals more than 2,000 publications.

MUS vs pubovaginal slings. In a recent updated systematic review of 39 randomized controlled trials comparing different SUI procedures, midurethral slings and pubovaginal slings had similar cure rates. Pubovaginal slings, however, had more postoperative lower urinary tract symptoms and a higher reoperation rate.⁴

Pubovaginal slings require an 8-cm lower-abdominal incision, general or regional anesthesia, and hospitalization (usually). They also have higher risks of intraoperative bleeding and wound complications (including incisional hernias) than MUS. By contrast, MUS require 3 small 1-cm incisions and can be performed on an outpatient basis with local anesthesia and sedation. Postoperative recovery is significantly easier and shorter with MUS than with pubovaginal slings. Pubovaginal slings performed with human cadaveric material and porcine material have inferior outcomes to autologous material.⁵

Modifications to MUS included transobturator approaches, which have comparable efficacy to the retropubic approach.⁶ In this century, the full-length MUS procedures are the predominant SUI surgical procedure and the clear standard of care.

In a recent study involving 53 urologists and urogynecologists (of whom >90% were fellowship-trained), use of full-length MUS was the preferred procedure in 93% of primary stress incontinence surgical procedures.⁷ In fact, full-length MUS have been so successful and safe that extrapolation of a small ribbon of mesh under the midurethra to larger sheets of mesh for the entire vagina is what produced our current transvaginal mesh controversy. The vaginal erosion rates of 10% that have been seen with much larger pieces of transvaginal mesh are only 1% with MUS.⁸ Studies have not demonstrated common or significant vaginal pain or pain with intercourse after MUS.

Let’s educate our patients

In my clinical practice, I have found that educating patients about the safety and efficacy of synthetic MUS is extremely successful. I urge you to not replace on a widespread basis the most studied, safe, and successful treatment for SUI with a procedure that is considerably more invasive and complicated and can be more painful and require a longer recovery. We all must do our best to clear up the confusion created by misleading television advertisements by law firms. Full-length synthetic midurethral slings remain the current standard of care for stress incontinence surgery.

INSTANT POLL. How do you educate your patients on the use of surgical mesh? Click here

The current surgical options for managing stress urinary incontinence (SUI) include:

These options—specifically MUS, which are the predominant SUI surgical procedure and the clear standard of care—remain in the surgeon’s armamentarium after the July 2011, FDA safety warning.¹

Confusion persists

A common misunderstanding is that full-length MUS were included in the FDA warning; however, the warning was about transvaginal mesh for prolapse and was titled, “Urogynecologic Surgical Mesh: Update on the Safety and Effectiveness of Vaginal Placement for Pelvic Organ Prolapse.”¹ In this document, it was explicitly stated: “The FDA continues to evaluate the effects of using surgical mesh for the treatment of SUI and will report about that usage at a later date.” In early 2012, when the FDA sent letters to industry for postmarketing approval study requests,² full-length MUS (but not single-incision mini-slings), were excluded from further study.

On page 24 of this issue, the technique for a pubovaginal sling is very well described by Drs. Karram and Zoorob in their article, “When and how to place an autologous rectus fascia pubovaginal sling.” There may be a place for this pubovaginal sling procedure for women with previous urethral surgery or radiation, but studies are needed to determine if repeat MUS or pubovaginal slings are the best procedure for recurrent incontinence. You should not get the impression that the current mesh controversy justifies abandoning the full-length MUS for a pubovaginal sling.

Unfortunately, television ads by law firms trawling for potential clients with any mesh in their vagina have created confusion among patients that synthetic MUS for incontinence is the same as transvaginal mesh for prolapse. In most clinical scenarios, rather than validating the patients’ concerns about the safety of synthetic mesh and performing a pubovaginal sling procedure, the most appropriate course of action is detailed, evidence-based patient education about MUS safety and efficacy to counter the patient’s misperceptions of safety concerns.

A bit of history on MUS

The first retropubic MUS was the tension-free vaginal tape (TVT) procedure published by Ulmsten in 1996.³ This minimally invasive outpatient procedure using a 1-cm wide strip of polypropylene mesh has revolutionized the management of SUI and has been the most studied surgical procedure in all of gynecology. A PubMed search of “tension- free vaginal tape” reveals more than 2,000 publications.

MUS vs pubovaginal slings. In a recent updated systematic review of 39 randomized controlled trials comparing different SUI procedures, midurethral slings and pubovaginal slings had similar cure rates. Pubovaginal slings, however, had more postoperative lower urinary tract symptoms and a higher reoperation rate.⁴

Pubovaginal slings require an 8-cm lower-abdominal incision, general or regional anesthesia, and hospitalization (usually). They also have higher risks of intraoperative bleeding and wound complications (including incisional hernias) than MUS. By contrast, MUS require 3 small 1-cm incisions and can be performed on an outpatient basis with local anesthesia and sedation. Postoperative recovery is significantly easier and shorter with MUS than with pubovaginal slings. Pubovaginal slings performed with human cadaveric material and porcine material have inferior outcomes to autologous material.⁵

Modifications to MUS included transobturator approaches, which have comparable efficacy to the retropubic approach.⁶ In this century, the full-length MUS procedures are the predominant SUI surgical procedure and the clear standard of care.

In a recent study involving 53 urologists and urogynecologists (of whom >90% were fellowship-trained), use of full-length MUS was the preferred procedure in 93% of primary stress incontinence surgical procedures.⁷ In fact, full-length MUS have been so successful and safe that extrapolation of a small ribbon of mesh under the midurethra to larger sheets of mesh for the entire vagina is what produced our current transvaginal mesh controversy. The vaginal erosion rates of 10% that have been seen with much larger pieces of transvaginal mesh are only 1% with MUS.⁸ Studies have not demonstrated common or significant vaginal pain or pain with intercourse after MUS.

Let’s educate our patients

In my clinical practice, I have found that educating patients about the safety and efficacy of synthetic MUS is extremely successful. I urge you to not replace on a widespread basis the most studied, safe, and successful treatment for SUI with a procedure that is considerably more invasive and complicated and can be more painful and require a longer recovery. We all must do our best to clear up the confusion created by misleading television advertisements by law firms. Full-length synthetic midurethral slings remain the current standard of care for stress incontinence surgery.

INSTANT POLL. How do you educate your patients on the use of surgical mesh? Click here