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
Ceragem Clinical Inc.
96 participants
Dec 13, 2024
INTERVENTIONAL
Conditions
Summary
This study is a multicenter, prospective, randomized, double-blind, sham-controlled clinical trial conducted in female patients with stress urinary incontinence.
Eligibility
Inclusion Criteria1
- Patients with urine leakage of ≥1 g on the standardized pad test
Exclusion Criteria3
- Patients with mixed urinary incontinence with predominant urgency urinary incontinence
- Patients with stress urinary incontinence
- Patients with overflow urinary incontinence
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Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07440927