Electroacupuncture Versus Pelvic Floor Muscle Training Plus Solifenacin for Women With Mixed Urinary Incontinence: A Randomized Noninferiority Trial
Abstract
Objective: To evaluate the efficacy and safety of electroacupuncture vs pelvic floor muscle training (PFMT) plus solifenacin for women with mixed urinary incontinence (MUI). Patients and Methods: This randomized controlled noninferiority trial was conducted at 10 hospitals in China between March 1, 2014, and October 10, 2016. Participants were randomized 1:1 to receive electroacupuncture (36 sessions) over 12 weeks with 24 weeks of follow‐up or PFMT‐solifenacin (5 mg/d) over 36 weeks. The primary outcome was percentage change from baseline to week 12 in mean 72‐hour incontinence episode frequency (IEF) measured by the 72‐hour bladder diary. It was analyzed in the per‐protocol set with a prespecified noninferiority margin of 15%. Results: Of 500 women with MUI who were randomized, 467 (239 in the electroacupuncture group and 228 in the PFMT‐solifenacin group) completed treatment per protocol and were included in the primary outcome analysis. At weeks 1 through 12, the percentage of reduction from baseline in mean 72‐hour IEF was 37.83% in the electroacupuncture group and 36.49% in the PFMT‐solifenacin group (between‐group difference, −1.34% [95% CI, −9.78% to 7.10%]; P<.001 for noninferiority), which demonstrates noninferiority; the treatment effect persisted throughout follow‐up. Statistically significant improvements were found for secondary outcomes in both groups, with no meaningful difference between treatments. Conclusion: In women with moderate to severe MUI,…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 500 participants or records.
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