Stress Urinary Incontinence for Female Patients (CGM MUIT-2301)

A Multi-center, Prospective, Randomized, Double-blind, Sham Device Controlled Clinical Trial to Compare and Evaluate the Efficacy and Safety of the Use an Investigational Device (Model Name CGM MUIT-2301) and Sham Device (Model Name CGM MUIT-2301C) for Female Patients With Stress Urinary Incontinence

This study is a multicenter, prospective, randomized, double-blind, sham-controlled clinical trial conducted in female patients with stress urinary incontinence.

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.

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