drugset / Trial / NCT03787654
Electroacupuncture and Solifenacin for Urgency-predominant Mixed Urinary Incontinence
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Solifenacin | Small molecule | 5 mg | Oral |
| Comparator | Solifenacin | Small molecule | 10 mg | Oral |