ABSTRACT
IMPORTANCE: Restricting activity after midurethral slings is an unproven practice. OBJECTIVE: The objective of this study was to evaluate the effect of postoperative activity restriction on satisfaction and outcomes after slings. STUDY DESIGN: This was a multicenter, 2-arm, noninferiority randomized controlled trial. Patients aged 18-85 years undergoing treatment with a midurethral sling were randomized 1:1 to postoperative activity restriction or liberal activity. Restrictions included avoidance of strenuous exercise and heavy lifting. The liberal group was allowed to resume activity at their discretion. Our primary outcome was satisfaction with postoperative instruction at 2 weeks. Secondary outcomes included surgical failure, mesh exposure rates, and other adverse events. RESULTS: In total, 158 patients were randomized with 80 to the liberal group and 78 to the restricted group. At 2 weeks, 54 (80.6%) of patients in the liberal group and 48 (73.9%) of patients in the restricted group were satisfied. We found statistical evidence supporting the hypothesis that postoperative liberal activity instruction is noninferior to activity restriction with regard to patient satisfaction (P = 0.0281). There was no significant difference in strenuous activity at 2 weeks (P = 0.0824). The liberal group reported significantly more moderate activity at 2 weeks (P = 0.0384) and more strenuous activity at 6 weeks and 6 months (P = 0.0171, P = 0.0118, respectively). The rate of recurrent or persistent stress incontinence for liberal versus restricted groups was 18.52% versus 23.53% (P = 0.635). There were no statistically significant differences in complication rates. CONCLUSIONS: Postoperative liberal activity was noninferior to activity restriction with regard to patients' satisfaction. There was no evidence supporting a statistically significant association between postoperative instruction and negative surgical outcomes.
ABSTRACT
INTRODUCTION AND HYPOTHESIS: Urinary tract infection is one of the most common adverse events following onabotulinumtoxinA injection for urgency incontinence. Our hypothesis was that those undergoing injection for urgency incontinence who received more than one dose of prophylactic antibiotics have lower post-procedure urinary tract infection rates compared to those who receive a single dose. METHODS: We conducted a multi-center retrospective cohort study in females who underwent onabotulinumtoxinA injection for non-neurogenic urgency incontinence to evaluate the effect of single- vs. multi-dose prophylactic antibiotic regimens on the risk of post-procedure urinary tract infection. The primary outcome was the rate of urinary tract infection within 30 days of injection. Our sample size calculation required 136 subjects per group. RESULTS: Two hundred eighty-one patients were included from four centers. The single-dose cohort included 145 patients (51.6%), and the multi-dose cohort included 136 patients (48.4%). The mean age was 65 years, and patients were primarily Caucasian (81.4%). There was no difference in the rate of urinary tract infections diagnosed within 30 days of injection between the cohorts (single dose 13.8% vs. multi-dose 10.3%, p = 0.369). Those with a positive urine culture within 30 days of injection had a 15.2 times greater odds of having a post-procedure infection than those who did not (95% CI 3.19-72.53). There was no significant difference between the two cohorts in terms of adverse health events following injection. CONCLUSIONS: In females with non-neurogenic urgency incontinence undergoing onabotulinumtoxinA injection, multi-dose prophylactic antibiotic regimens were not associated with lower post-procedure urinary tract infection rates.
