Duration of Activity Restrictions after Midurethral Sling: A Randomized Controlled Trial

Objectives: To assess the impact of a shorter duration of post operative activity restrictions on patient satisfaction and surgical outcomes after midurethral sling (MUS) surgery for stress urinary incontinence (SUI)

Methods: Adult women undergoing MUS alone for SUI were invited to enroll in this provider-blinded, randomized clinical trial. Participants were randomized to either a short duration (3 weeks) or a standard duration (6 weeks) activity restriction group. Activity restrictions included abstaining from lifting greater than 20 pounds, high impact activity or strenuous exercise. The primary outcome, measured at 6 months, was patient satisfaction with surgery and duration of post operative restrictions, using a 5-point Likert Patient Satisfaction scale. Satisfaction scores were analyzed in a “complete satisfaction” (responses of “completely” satisfied only) and a “higher satisfaction” approach (included both “completely” and mostly” satisfied). Secondary outcomes included cough stress test at 6 months, and validated questionnaires such as Urinary Distress Inventory- Long (UDI- Long), Incontinence Impact Questionnaire- Short Form (IIQ-7), Patient Global Impression of Improvement (PGI-I), and Activity Assessment Scale (AAS), collected at baseline, and postoperatively at 6-weeks, and 6-months. A sample size of 41 participants per group was calculated using a P=0.05, 90% power, assuming a 10% dropout rate, and anticipating baseline 90% satisfaction for MUS with a 27% difference between groups. Statistical analysis used χ2 Fisher exact test as appropriate and for categorical and dichotomized data and two sample Wilcoxon test for continuous data

Results: From July 2021 to September 2022, 98 women undergoing MUS were screened and 88 were randomized to either group. Of them, 84 participants completed the primary outcome (n=41 3-week restrictions; n=43 6-week restrictions). Baseline characteristics including demographics, surgical intervention, subjective urinary symptoms and prior overactive bladder diagnosis or treatment did not differ between groups. Most women underwent retropubic midurethral sling (76) compared to transobturator midurethral sling (6). At 6- month postoperative visit, overall patient satisfaction (“completely” and “mostly” satisfied) was very high at 92%. Significantly higher satisfaction in 3 week (73.2%) compared to 6-week restriction group (51.2.0%) (P= 0.04) was noted with “complete” satisfaction approach. When “higher satisfaction” was compared, an important difference was noted in the 3-week (97%) compared to the 6-week restriction group (86%), though not meeting statistical significance (P=0.11) The rates of a positive cough stress test, UDI-total score, UDI-stress subscale, and UDI-irritative subscales did not differ between groups, as shown in table 1.

Conclusions: Return to normal activities 3 weeks after MUS resulted in significantly higher satisfaction scores at 6 months compared to 6-week restriction. This increase in patient satisfaction may come without reducing subjective and objective MUS success