drugset / Trial / NCT03787654

Electroacupuncture and Solifenacin for Urgency-predominant Mixed Urinary Incontinence

NCT03787654

RandomizedParallel-groupDouble-blindTreatment

Summary

The study is to determine the effect of electroacupuncture in female patients with urgency-predominant mixed urinary incontinence. A three-arm non-inferior randomized controlled trial (RCT) using electroacupuncture, sham electroacupuncture and solifenacin with a total sample of 282 is proposed. The hypothesis is that the improvement (difference in number of urgency urinary incontinence episodes between baseline and 12-week evaluation) in the electroacupuncture group would be 50% or less of the difference in the improvement between the Solifenacin and the sham electroacupuncture groups.

Timeline

Start
2019-03-01
Primary completion
2022-12-30
Completion
2023-06-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Solifenacin Small molecule 5 mg Oral
Comparator Solifenacin Small molecule 10 mg Oral