Stress Urinary Incontinence for Female Patients (CGM MUIT-2301)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ceragem Innerfit medi-tech.
- Who it may be relevant to
- Registry conditions: Stress Urinary Incontinence (SUI). Basic parameters: from 19 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- 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.
Primary outcome measures
- Proportion of patients with urine leakage <1 g [Time frame: at week 12 compared with baseline.]
Secondary outcome measures (11)
- Proportion of patients with urine leakage <1 g [Time frame: at Weeks 4, 8, and 12 from baseline]
- Proportion of patients with urine leakage ≥ 50% [Time frame: at Weeks 12.]
- Proportion of patients with urine leakage ≥ 75% [Time frame: at Weeks 12.]
- Change and percent change from baseline in the mean the standardized pad test [Time frame: at Weeks 4 and 12.]
- Change and percent change from baseline in the average number of urinary incontinence episodes [Time frame: at Weeks 12.]
- Change and percent change from baseline in the total and subscale scores [Time frame: at Weeks 4, 8, and 12 from baseline]
- Change and percent change from baseline in the total and subscale scores [Time frame: at Weeks 12 from baseline]
- Change and percent change from baseline in the Patient Perception of Intensity of Urgency Scale (PPIUS; 5-point scale) score [Time frame: at Weeks 4, 8, and 12 from baseline]
- Pelvic floor muscle assessment [Time frame: at week 12 from baseline]
- Intravaginal pressure assessment [Time frame: at week 12 from baseline]
- Patient Global Impression of Improvement (PGI-I) [Time frame: at week 12 from baseline]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
South Korea · 1 center
- Samsung Seoul Hospital — Seoul
Identifiers
NCT: NCT07440927 · CC_UIT_307