RecruitingNot ApplicableNCT07440927

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

Sponsor

Ceragem Clinical Inc.

Enrollment

96 participants

Start Date

Dec 13, 2024

Study Type

INTERVENTIONAL

Conditions

Stress Urinary Incontinence (SUI)

Summary

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

Eligibility

Sex: FEMALEMin Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Ceragem Innerfit medi-tech for people with stress urinary incontinence (sui). The study is currently recruiting participants at 1 location. People eligible for this study include women aged 19 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICECeragem 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.