National Guideline Clearinghouse | Expert Commentaries: AUA's Surgical Management of Female Stress Urinary Incontinence Provides Timely Update

May 16, 2011
AUA's Surgical Management of Female Stress Urinary Incontinence Provides Timely Update

By: Jennifer T. Anger, MD, MPH

Related Guideline: Guideline for the surgical management of female stress urinary incontinence: 2009 update [National Guideline Clearinghouse | Guideline for the surgical management of female stress urinary incontinence: 2009 update.].

The field of female pelvic medicine has seen a rapid shift of surgical procedures for stress urinary incontinence (SUI). Procedures such as the needle suspension, the Marshall-Marchetti-Krantz anterior urethropexy, and Kelly plication were temporarily superseded by collagen injections in the late 1990s, and then overwhelmed by the sling procedure. (1) These rapid shifts in technique likely represent a desire on the part of surgeons to provide a more efficacious, yet minimally invasive, procedure. Historically, however, level I evidence to support such rapid shifts in care has been lacking. In 1997, the American Urological Association's (AUA's) first Female Stress Urinary Incontinence Clinical Guidelines Panel report was published. This was based on a review of the literature available up to January of 1994. (2) The AUA greatly expanded the scope of the previous version in the Guideline for the surgical management of female stress urinary incontinence: 2009 update by reviewing publications up to June of 2005, including 436 articles addressing efficacy and 155 additional articles addressing complications.* (3)

Most guidelines addressing this topic focus on both the diagnostic evaluation and surgical treatment of the index patient with SUI without significant pelvic organ prolapse. The AUA 2009 update differs in that it includes an additional index patient with both SUI and prolapse. Another change is the application of a grading scheme with three levels. The committee rated guidelines Standard when there was unanimity among panelists and "...the health outcomes of the alternative interventions are sufficiently well known to permit meaningful decisions." (3) A designation of Recommendation was applied if an appreciable, but not unanimous, majority agreed on the intervention, and Option was used if preferences were equivocal and data on health outcomes was lacking. For example, components of the evaluation considered Standard include a focused history and physical examination, objective demonstration of SUI, a urinalysis, and an assessment of post-void residual urinary volume. Although data on the impact of a pre-operative post-void residual are lacking, measuring a post-void residual will identify a significant emptying problem that could cause urinary retention after incontinence surgery. Recommendations regarding diagnostic work-up include a more detailed characterization of symptoms and impact on quality of life, as well as further diagnostic testing when indicated. Some testing modalities, such as urodynamics and especially cystoscopy, are not indicated in the index patient with pure SUI and no history of complicating factors. In fact, the frequent use of these diagnostic modalities among Medicare beneficiaries likely reflects overuse. (4)

The first Standard treatment guidelines for the index patient address pre-operative counseling and informed consent, and the need for a collaborative effort between the surgeon and patient. In October of 2008, the U.S. Food and Drug Administration (FDA) issued a warning regarding complications unique to the use of vaginally placed synthetic mesh. (5) Although the FDA based its warning primarily on complications that occurred from the use of prolapse "kits," there has been an important shift toward patient counseling for all vaginally placed mesh, including slings. The FDA recommended that surgeons discuss specific mesh-related complications with patients prior to surgery. The AUA committee also advised (as a Standard) against performing SUI surgery for pure urge incontinence. Although this seems obvious, this type of surgical management unfortunately happens in practice, resulting in the exacerbation of patient symptoms from surgery. Also, the committee makes a Recommendation regarding the contraindication of synthetic slings when the urethra is entered surgically, whether purposefully or inadvertently, as this would place the patient at undue risk of urethral erosion. Although data behind this recommendation are lacking, and some exceptions may exist, this guideline errs on the side of patient safety to prevent serious complications of mesh erosion into the urinary tract. The committee held as Standard the use of intra-operative cystoscopy in all patients undergoing sling surgery, as passage of trocars/passers or sling material happens frequently, and, if not recognized, can lead to serious delayed complications. If recognized at the time of surgery, the sling and/or passers can simply be removed and replaced, and most bladder injuries are managed with short-term catheter drainage. The committee considered as an Option surgical procedures for women with mixed urge and SUI, and for women undergoing concomitant prolapse surgery. They included a Recommendation that tensioning of any sling should be performed after prolapse surgery is completed. Although this guidance is intuitive, supporting data on this topic are again lacking.

The committee included as an Option consideration of five major types of procedures for the index patient, and the indication of the artificial urinary sphincter in certain circumstances. Since the development of the 2009 update, new level I evidence is available further guiding the surgical management of SUI. Work of the National Institutes of Health (NIH)-funded networks, the Urinary Incontinence Treatment Network (UITN) and the Pelvic Floor Disorders Network (PFDN), has set a higher standard for research in the field of female pelvic medicine. The Stress Incontinence Surgical Treatment Efficacy Trial (SISTEr), a multi-center randomized trial comparing outcomes and complications between class bladder neck slings and the Burch colposuspension, was the first to provide level I evidence that slings had better long-term efficacy than the Burch colposuspension. (6) And yet, more voiding dysfunction occurred after the sling, including urinary retention and de novo urge incontinence. This likely reflects the more compressive, and even obstructive, nature of the sling. Regardless, by the time the data from the SISTEr trial was published, many pelvic surgeons had already shifted surgical technique to the minimally invasive mid-urethral synthetic sling. Data recently published from the Trial of Mid-Urethral Slings (TOMUS) demonstrated similar intermediate-term (one year) efficacy between transobturator and retropubic synthetic slings placed at the mid-urethra. (7) Retropubic approaches had more intra-operative bladder injuries from trocar passage, while transobturator approaches had more leg numbness after surgery. At the present time, single incision mini-slings have entered the market, and, again, new shifts in care have begun.

With this update the AUA has raised the quality of research in pelvic floor medicine while providing much needed guidance on this topic. Urologists in particular will be interested to see this guideline based on current evidence. We are fortunate for the presence of networks dedicated to randomized clinical trials, and for the commitment of committees such as the AUA's Stress Urinary Incontinence Guideline Panel to providing the most up-to-date clinical guidance to benefit our patients.

* The author notes that the AUA dedicated the "2009 Update of the Guideline for the Surgical Management of Female Stress Urinary Incontinence" to the memory of Dr. Rodney Appell, who chaired this panel through this large undertaking.


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Author

Jennifer T. Anger, MD, MPH
Cedars-Sinai Medical Center, Beverly Hills, CA

Disclaimer

The views and opinions expressed are those of the author and do not necessarily state or reflect those of the National Guideline Clearinghouse™ (NGC), the Agency for Healthcare Research and Quality (AHRQ), or its contractor ECRI Institute.

Potential Financial Conflicts of Interest

Dr. Anger declared no potential conflicts of interest with respect to this expert commentary.

References

1.Anger JT WA, Albo ME, Smith AL, Kim JH, Rodríguez LV, Saigal CS. Trends in surgical management of stress urinary incontinence among female Medicare beneficiaries. Urology. 2009;74(2):283-287.
2.Leach GE DR, Appell RA, Blaivas JG, Hadley HR, Luber KM, Mostwin JL, O'Donnell PD, Roehrborn CG. Female Stress Urinary Incontinence Clinical Guidelines Panel summary report on surgical management of female stress urinary incontinence. The American Urological Association. J Urol. 1997;158(3 Pt 1):875-880.
3.Dmochowski RR BJ, Gormley EA, Juma S, Karram MM, Lightner DJ, Luber KM, Rovner ES, Staskin DR, Winters JC, Appell RA; Female Stress Urinary Incontinence Update Panel of the American Urological Association Education and Research, Inc., Whetter LE. Update of AUA guideline on the surgical management of female stress urinary incontinence. J Urol. 2010;183(5):1906-1914.
4.Anger JT RL, Wang Q, Pashos CL, Litwin MS. The role of preoperative testing on outcomes after sling surgery for stress urinary incontinence. J Urol. 2007;178(4 Pt 1):1364-1368.
5.FDA Public Health Notification: Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence. Available at http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm061976.htm . Accessed on February 6, 2011.
6.Albo ME RH, Brubaker L, Norton P, Kraus SR, Zimmern PE, Chai TC, Zyczynski H, Diokno AC, Tennstedt S, Nager C, Lloyd LK, FitzGerald M, Lemack GE, Johnson HW, Leng W, Mallett V, Stoddard AM, Menefee S, Varner RE, Kenton K, Moalli P, Sirls L, Dandreo KJ, Kusek JW, Nyberg LM, Steers W; Urinary Incontinence Treatment Network. Burch colposuspension versus fascial sling to reduce urinary stress incontinence. N Engl J Med. 2007;356(21):2143-2155.
7.Richter HE AM, Zyczynski HM, Kenton K, Norton PA, Sirls LT, Kraus SR, Chai TC, Lemack GE, Dandreo KJ, Varner RE, Menefee S, Ghetti C, Brubaker L, Nygaard I, Khandwala S, Rozanski TA, Johnson H, Schaffer J, Stoddard AM, Holley RL, Nager CW, Moalli P, Mueller E, Arisco AM, Corton M, Tennstedt S, Chang TD, Gormley EA, Litman HJ; Urinary Incontinence Treatment Network. Retropubic versus transobturator midurethral slings for stress incontinence. N Engl J Med. 2010;362(22):2066-2076.

National Guideline Clearinghouse | Expert Commentaries: AUA's Surgical Management of Female Stress Urinary Incontinence Provides Timely Update