NCT07440927

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: Ceragem Clinical Inc. · Industry
• Sex: Female
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Stress Urinary Incontinence (SUI)

Interventions

Type	Name	Description
DEVICE	Ceragem Innerfit medi-tech	Stress Urinary Incontinence Device (Ceragem Innerfit medi-tech) The investigational device and control device were applied at least 5 days per week, twice daily (morning and evening), for 15 minutes per session, over a total period of 12 weeks.

Timeline

• Start date: 2024-12-13
• Primary completion: 2026-09-30
• Completion: 2026-09-30
• First posted: 2026-02-27
• Last updated: 2026-02-27

Locations

1 site across 1 country: South Korea