Effect of behavioral and pelvic floor muscle therapy combined with surgery versus surgery alone on incontinence symptoms among women with mixed urinary incontinence

Abstract

It is estimated that urinary incontinence (UI) affects up to 58% of women and has a significant negative impact on their quality of life. Mixed UI includes both stress and urgency incontinence and is present in up to half of women with UI. Mixed incontinence is often considered more severe than UI, responds poorly to treatment, and ismore difficult to manage than either urinary condition alone. Studies evaluating treatments that simultaneously improve both components of mixed UI are lacking. First-line treatment includes conservative therapy, behavioral and pelvic floor muscle training, followed by overactive bladder medication. Surgery with sling procedures can worsen urgency, and for this reason, clinical guidelines recommend treating the urgency component prior to consideration of surgery. Observational data support the effectiveness of midurethral sling surgery for treating the stress component. However, there are only limited data among women with mixed incontinence or approaches to improve urgency incontinence outcomes after midurethral sling. One strategy that has the potential to treat stress and urgency incontinence concurrently in women with mixed UI is combining conservative therapy with surgery, but the efficacy among women with mixed incontinence is unclear. The aim of this multicenter, randomized, superiority trial was to determine whether combining behavioral and pelvic floor muscle therapy with midurethral sling is more effective than sling alone for improving UI symptoms in women with mixed UI. Subjects were women 21 years or older, who reported moderately to severely bothersome symptoms of stress and urgency incontinence for at least 3 months and documented at least 1 stress and 1 urgency incontinence episode on a 3-day bladder diary. The study was conducted in the United States across 9 sites in the Pelvic Floor Disorders Network. Patients were enrolled between October 2013 and April 2016, with final follow-up in October 2017. Conservative therapy, behavioral and pelvic floor muscle therapy, included 1 preoperative and 5 postoperative sessions through 6 months combined with midurethral sling (n = 209) or sling alone (n = 207). Surgeons and outcome assessors were masked, but patients and interventionists were not. Change in mixed UI symptoms at 12 months, the primary outcome, was measured using the Urogenital Distress Inventory (UDI) long-form total score (range, 0-300 points; minimal clinically important difference, 35 points; higher scores indicate greater symptom severity). Mean age was 54.0 (SD, 10.7) years. Of the 480 women randomized, 416 were eligible (209 combined, 207 sling only), had postbaseline outcome data, and were included in primary analyses. In the combined group, the UDI score significantly decreased (from 178.0 points at baseline to 30.7 points at 12 months); the adjusted mean change was -128.1 points, with a 95% confidence interval (CI) of -146.5 to -109.8. In the sling-only group, the UDI score significantly decreased (from 176.8 to 34.5 points); the adjusted mean change was -114.7 points, with a 95% CI of -133.3 to -96.2. The model-estimated between-group difference of -13.4 points (95% CI, -25.9 to -1.0; P = 0.04) did not meet the minimal clinically important difference threshold for clinical importance. Serious adverse events occurred in 10.2% of the participants (8.7% combined and 11.8% sling only). Only 2.3% of these were considered to be possibly, probably, or definitely related to the intervention.

These data show that among women with mixed UI, behavioral and pelvic floor muscle therapy combined with midurethral sling surgery, when compared with surgery alone, resulted in a small statistically significant difference in UI symptoms at 12 months. The difference, however, did not meet the prespecified threshold for clinical importance.