Activity Restrictions after Midurethral Slings: A Randomized Non-Inferiority Clinical Trial

Objectives: To evaluate the impact of postoperative activity restriction on patient satisfaction with postoperative instruction and surgical outcomes after midurethral slings.

Methods: This was a multicenter, two-armed, parallel, non-inferiority randomized controlled trial. Eligibility requirements included age 18-85 years, urodynamic or clinical stress incontinence, and planned treatment with a midurethral sling. Exclusion criteria included prior anti-incontinence procedure, pelvic reconstruction, pelvic radiation, baseline activity limitation, prolapse >0 on POPQ exam, or future childbearing plans. Patients were randomized to postoperative activity restriction or liberal activity. Activity restrictions included avoidance of strenuous exercise and lifting more than 10lbs. The liberal arm was allowed to resume activity at their discretion. All patients were on complete pelvic rest for 6 weeks.

Our primary outcome was satisfaction with postoperative instruction at 2 weeks. Satisfaction was assessed using a 5-point Likert Scale that asked, "How satisfied were you with your postoperative instructions?". Liberal activity instructions were considered non-inferior to restricted activity if the lower bound of the 1-sided confidence interval of the risk difference was within a 10% margin.

Secondary outcomes, including surgical failure and adverse events, were assessed via Chi-square test of association. Surgical failure was a composite outcome of positive cough stress test at 6 months, bothersome stress incontinence, or retreatment. Both intention-to-treat and per-protocol analyses were performed.

Results: 158 patients were randomized with 78 to the restricted activity arm and 80 to the liberal activity arm. At 2 weeks, only 65 (83%) from the restricted group and 68 (85%) from the liberal group responded to the satisfaction survey. Of those who responded, 48 (73.9%) of the restricted group and 55 (80.9%) of the liberal group indicated being satisfied with their postoperative instruction.

We found statistical evidence supporting the hypothesis that postoperative liberal activity instruction is non-inferior to activity restriction with regards to patient satisfaction; the 95% lower bound confidence interval was within the 10% margin (95% Lower CI =-0.0499).

There was no evidence supporting a statistically significant association between postoperative instruction and surgical failure (Liberal 17.4% vs Restricted 21.6%, p=0.6628) or between instruction arm and rate of adverse events (Liberal 28.6% vs Restricted 37.8%, p=0.4045). Specifically, there was no significant association between activity instruction and mesh exposure, de novo urgency, and recurrent or persistent stress incontinence.

The liberal group had significantly more minutes per day and days of strenuous activity at all time points.

Conclusions: Liberal activity instruction was found to be non-inferior to activity restrictions with regards to patient satisfaction with their postoperative instructions at 2 weeks after a midurethral sling. There was no evidence supporting a statistically significant association between postoperative instruction and surgical failure or adverse outcomes. Decreased levels of strenuous activity persisted at 6 months in the restricted group even after their restrictions were lifted.