Overview
This study is a multicenter, prospective, randomized, double-blind, sham-controlled clinical trial conducted in female patients with stress urinary incontinence.
Description
Participants will receive either a non-implantable neuromuscular electrical stimulation device for urinary incontinence or a sham control device, administered at home for at least 5 days per week, twice daily (morning and evening), with each session lasting 15 minutes, over a total treatment period of 12 weeks.
The primary objective of this study is to compare the difference between treatment groups in the proportion of patients whose stress urinary incontinence improves to less than 1 g on the standardized pad test at Week 12.
Eligibility
Inclusion Criteria:
- Patients with urine leakage of ≥1 g on the standardized pad test
Exclusion Criteria:
- Patients with mixed urinary incontinence with predominant urgency urinary incontinence
- Patients with stress urinary incontinence
- Patients with overflow urinary incontinence
