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By Chiara Ghetti, MD
Associate Professor of Obstetrics and Gynecology, Division of Female Pelvic Medicine and Reconstructive Surgery, Washington University School of Medicine, St. Louis
Dr. Ghetti reports no financial relationships relevant to this field of study.
Knowing the best way to counsel patients regarding the risks, benefits, and alternatives of performing an incontinence procedure at the time of reconstructive pelvic surgery for pelvic organ prolapse (POP) can be challenging. Pelvic floor disorders frequently coexist,1 and a woman with POP might also experience stress urinary incontinence (SUI). It is estimated that these conditions coexist up to 80% of the time.2 By reestablishing the relationships between bladder neck and urethral position, prolapse repair surgery can unmask stress incontinence in women without SUI symptoms prior to surgery or worsen existing leakage. Various studies have tried to address the question of whether to perform concomitant incontinence surgery; however, despite rising trends in concomitant apical and incontinence procedures in the United States,3 controversy remains. Tailoring surgery to patients’ unique needs and characteristics can remain challenging. This feature will review some of the evidence and resources to better understand combined treatment for prolapse and incontinence.
It may be helpful to begin by briefly defining some of the recurring terms used in these discussions. The International Continence Society (ICS) defines SUI as “the complaint of any involuntary loss of urine on effort or physical exertion (e.g., sporting activities) or on sneezing or coughing.”4 De novo SUI is used to describe new symptoms of urinary incontinence following surgery. Occult SUI refers to urinary leakage that is witnessed at the time of evaluation or testing while prolapse is being supported in a woman with no symptoms of SUI. Evaluation or testing includes having the patient cough with a full bladder (cough stress test). Supporting prolapse during such an evaluation is referred to as prolapse reduction testing.
Although the midurethral sling is recognized as the standard of care for the surgical treatment of SUI, prior to its widespread use, SUI was treated surgically via the Burch procedure and fascial slings. The Abdominal Sacrocolpopexy with Burch Colposuspension to Reduce Urinary Stress Incontinence, or CARE trial, was published in 2006.5 This multicenter randomized trial was designed to determine whether performing a Burch procedure at the time of abdominal sacrocolpopexy would decrease postoperative SUI in women without preoperative symptoms of SUI. This study of 322 women found that the addition of the Burch procedure in women without preoperative SUI undergoing sacrocolpopexy for prolapse significantly reduced the risk of postoperative SUI without increasing the risk of additional lower urinary tract symptoms. Soon after this study was published, Burch procedures became less prominent as midurethral slings became the leading SUI procedure. The midurethral sling has a different risk profile, and the CARE findings cannot be generalized to slings.
Chronologically, the next study that attempted to address the issue of concomitant incontinence procedure at the time of prolapse repair was the Outcomes Following Vaginal Prolapse Repair and Midurethral Sling (OPUS) trial.6 This also was a large, multicenter, randomized trial. It was designed to ascertain whether the prevalence of urinary incontinence after prolapse surgery was different between women without incontinence who do and do not have a concomitant midurethral sling at the time of vaginal procedure for prolapse repair. The OPUS trial included 337 women randomized to receive either Gynecare retro pubic tension-free vaginal tape (TVT) or sham surgery consisting of two 1 cm suprapubic, superficial incisions identical to sling abdominal incisions. Ethicon, the sling manufacturer, was not involved with this study. The study found that subjects who did not receive a sling had nearly double the rates of urinary incontinence postoperatively compared to those who did receive the sling. However, at 12 months, the number of incontinence procedures performed did not statistically differ between subjects in both groups. Only 11% of patients in the sham group underwent subsequent treatment for incontinence. Subjects who received a sling were more likely to have experienced adverse events in the first six weeks postoperatively, including bladder perforation, urinary tract infection, major bleeding complications, and incomplete bladder emptying. The authors estimated that to prevent one case of urinary incontinence at 12 months following vaginal prolapse repair, 6.3 women need to be treated with a sling. A smaller randomized trial of 80 subjects investigated whether performing a midurethral sling at the time of prolapse repair improves postoperative urinary incontinence in women with occult SUI, and similarly found no difference in postoperative sling rates between groups.7 The authors concluded that the practice of routine use of a sling procedure for occult incontinence at the time of prolapse surgery is questionable.
A Cochrane review published in 2018 attempted to determine the effect of POP repair with or without concomitant vs. staged SUI procedure on postoperative bladder function.8 The authors concluded that in women with prolapse and SUI (both symptomatic and occult SUI), a concurrent midurethral sling at the time of prolapse repair likely reduces postoperative SUI and should be discussed in preoperative counseling. The authors also proposed that postponing a midurethral sling and performing a staged procedure also is a feasible option. Again, this review included both women with SUI and occult incontinence.
So what about women with SUI before prolapse surgery? Guigale et al attempted to better understand this by investigating what percentage of women with preoperative SUI experience resolution of their incontinence after surgery for pelvic organ prolapse without a concomitant incontinence procedure.9 In this retrospective observational study of 93 women with symptomatic and objective SUI undergoing abdominal or vaginal prolapse repairs, one-third had resolution of preoperative SUI with prolapse repair alone without concomitant sling. This suggests that if performing a routine concomitant sling for all women with SUI who are undergoing prolapse repair, one-third might be having an unnecessary procedure.
These studies highlight the importance of counseling and shared decision-making in determining the best approach to the surgical correction of pelvic organ prolapse both with and without SUI. Alongside these studies, a helpful resource for providers and patients is an online risk calculator developed by Jelovsek et al for predicting the risk of de novo SUI in women undergoing vaginal surgery for pelvic organ prolapse.10 This model was developed and then tested using the CARE and OPUS trial data and was found to have good predictive accuracy. The currently used preoperative prolapse reduction testing employed in predicting postoperative SUI prior to surgery has a reported sensitivity of only 17-39%. This individualized prediction model is for de novo SUI after vaginal pelvic organ prolapse surgery, is valid, and appears to be better at predicting de novo SUI than a preoperative reduction stress testing and prediction by experts.
Prolapse and incontinence coexist in a large number of patients. Determining the best approach to surgical repair requires balancing many factors: the risks of individual surgeries, the possibility of incomplete resolution of symptoms or development of new symptoms, the need for future surgery, as well risks of complications, including but not limited to hematoma, bladder injury, voiding dysfunction, and mesh exposure. In women with prolapse and SUI, concomitant surgeries for prolapse and incontinence are indicated; however, a staged approach still may be an appropriate option. For women with prolapse and no SUI symptoms, the decision-making is more complex. Further factors to include in the shared decision-making are the extent of prolapse, the surgical approach to repair, preoperative reduction testing, the presence or absence of occult incontinence, and results of the risk calculator. The shared decision-making also requires an understanding of the patient’s symptoms, medical decision-making values, and treatment goals and expectations, as well as personal values and priorities.
Financial Disclosure: OB/GYN Clinical Alert’s Editor Jeffrey T. Jensen, MD, MPH, reports that he is a consultant for and receives grant/ research support from ObstetRx, Bayer, Merck, and Sebela; he receives grant/research support from AbbVie, Mithra, and Daré Bioscience; and he is a consultant for CooperSurgical and the Population Council. Peer Reviewer Catherine Leclair, MD; Nurse Planner Marci Messerle Forbes, RN, FNP; Editorial Group Manager Leslie Coplin; Editor Jason Schneider; and Executive Editor Shelly Mark report no financial relationships relevant to this field of study.