Cost Effectiveness of Concurrent Midurethral Sling at the Time of Prolapse Repair: Results From a Randomized Controlled Trial

Abstract

ABSTRACT After pelvic reconstructive surgery for pelvic organ prolapse, postoperative stress urinary incontinence (SUI) commonly occurs, which leads many women to choose to have a midurethral sling placed at the time of surgery, even in cases without symptomatic preoperative urinary incontinence. Approximately 27.3% of women with a sling had de novo SUI despite this intervention. Full evaluation of the societal and economic implications brought by a midurethral sling placement attempting to prevent postoperative de novo SUI at the time of a pelvic reconstructive surgery have yet to be evaluated. This study aimed to evaluate the 1-year cost-effectiveness of a midurethral sling in the prevention of SUI at the time of prolapse surgery. This assessment was a randomized controlled trial based on patient resource utilization and patient-reported effectiveness. Study data were obtained via the OPUS randomized clinical trial, which was performed through the Pelvic Floor Disorders Network (a cooperative agreement network sponsored through the National Institute of Child Health and Human Development). A total of 337 women with anterior vaginal prolapse and without SUI symptoms set to undergo treatment from May 2007 to January 2011 were included in the study. Patients were randomly assigned to receive either sham incisions or a midurethral sling during vaginal prolapse surgery. Follow-up occurred at 3, 6, and 12 months postsurgery, with surveys, physical examinations, and medical history. Cost data were collected, and overall health utility in quality-adjusted life-years (QALYs) was calculated. Secondary outcomes were urinary incontinence-specific quality of life and cases of urinary incontinence, as defined by bothersome incontinence symptoms and positive cough stress tests. Initial surgical procedures and subsequent urinary incontinence-related health care were all used for recording health care sector costs. Total costs for study participants were collected via health care resource utilization data, including office visits, additional surgical procedures, and related procedures. The incremental cost-effectiveness ratio was the difference between the sham incision and midurethral sling groups in mean cost, divided by difference in mean QALYs. Data for health care resource utilization were collected during the trial period. Questionnaires at baseline, 3, 6, 9, and 12 months were used to collect other costs. At 1 year, one-way sensitivity analysis was performed for assessing the varying effectiveness of midurethral slings at 1 year, by noting the urinary incontinence-associated patient costs and by using varied QALY for the sling group. Results were taken from a study population of 337 women who underwent randomization to be included in the analysis of cost-effectiveness. No great variance of characteristics existed between groups. One year after surgery, a lower rate of urinary incontinence existed for those in the midurethral sling group. Notably, QALYs were not statistically different between midurethral sling and sham incision groups at baseline, but at 12 months, there was an improvement in both the UDI stress subscale and an overall reduction in the Incontinence Severity Index for the midurethral sling group. In conclusion, although prophylactic midurethral sling placements during vaginal prolapse surgery does reduce the rate of de novo SUI, based on this analysis of date from the OPUS trial, it is not a cost-effective intervention. The decision to place a sling in this setting is often driven by cost savings on the patient side, whereas midurethral sling health care costs are higher than when sling is not done.