At-home electrical stimulation treatment for stress urinary incontinence in women
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
NA · Ceragem Inc. · NCT07440927
This trial will test whether a non-implantable at-home electrical stimulation device can reduce urine leakage in women with stress urinary incontinence.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 96 (estimated) |
| Ages | 19 Years and up |
| Sex | Female |
| Sponsor | Ceragem Inc. (industry) |
| Locations | 1 site (Seoul) |
| Trial ID | NCT07440927 on ClinicalTrials.gov |
What this trial studies
This is a randomized, double-blind, sham-controlled multicenter trial enrolling women with stress urinary incontinence. Participants are assigned to either a non-implantable neuromuscular electrical stimulation device or a sham device and self-administer treatment at home twice daily for 15 minutes, at least five days per week, for 12 weeks. The primary outcome is the proportion of patients whose leakage falls below 1 g on the standardized pad test at Week 12. Patients with predominant urgency or overflow incontinence are excluded and must complete baseline and follow-up visits at the study site.
Who should consider this trial
Good fit: Women with stress urinary incontinence who have at least 1 g of leakage on the standardized pad test and who can follow twice-daily at-home sessions and attend study visits are ideal candidates.
Not a fit: Patients whose leakage is mainly due to urgency or overflow incontinence, or those with less than 1 g on the pad test, are unlikely to benefit from this device.
Why it matters
Potential benefit: If successful, the device could substantially reduce or eliminate stress-related urine leakage and offer a convenient non-surgical at-home option.
How similar studies have performed: Previous randomized trials of home pelvic-floor electrical stimulation have shown mixed but generally promising reductions in stress-related urine leakage.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Seoul
- Samsung Seoul Hospital — Seoul, South Korea (RECRUITING)
Study contacts
- Principal investigator: Kyu Sung Lee, MD — Samsung Seoul Hospital
- Study coordinator: Myeongbae Shin, Researcher
- Email: mbshin94@ceragem.com
- Phone: 82-10-4373-2808
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Stress Urinary Incontinence