Stress Urinary Incontinence (SUI)NCT07440927
Stress Urinary Incontinence for Female Patients (CGM MUIT-2301)
A study testing Ceragem Innerfit medi-tech in people with Stress Urinary Incontinence (SUI), run by Ceragem Clinical Inc. at 1 site in South Korea.
Trial summary
This study is a multicenter, prospective, randomized, double-blind, sham-controlled clinical trial conducted in female patients with stress urinary incontinence. Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Stress Urinary Incontinence (SUI)
- What is being tested?
- Ceragem Innerfit medi-tech
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Dec 2024to 30 Sep 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with urine leakage of ≥1 g on the standardized pad test
Who cannot join
- Patients with mixed urinary incontinence with predominant urgency urinary incontinence
- Patients with stress urinary incontinence
- Patients with overflow urinary incontinence
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Seoul Hospital
Seoul
Kyu sung Lee, MD, 82-2-3410-0200
About this study
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
This study is a multicenter, prospective, randomized, double-blind, sham-controlled clinical trial conducted in female patients with stress urinary incontinence.
Read the 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)
- Being tested
- Ceragem Innerfit medi-tech
- Keywords
- Stress Urinary Incontinence (SUI)
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ceragem Innerfit medi-techDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Non-implantable neuromuscular electrical stimulation (NMES) group | Experimental | Non-implantable neuromuscular electrical stimulation (NMES) group for urinary incontinence Receives: Device: Ceragem Innerfit medi-tech |
| Comparator device group | Sham comparator | Non-implantable neuromuscular electrical stimulation (NMES) without electrical stimulation group for urinary incontinence Receives: Device: Ceragem Innerfit medi-tech |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with urine leakage <1 g
Proportion of patients with urine leakage <1 g on the standardized pad test at Week 12 compared with baseline.
Measured: at week 12 compared with baseline.
Secondary outcomes (11)
Proportion of patients with urine leakage <1 g
Change from baseline and percent change in ICIQ-UI-SF(International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form) scores at Weeks 4, 8, and 12.
Measured: at Weeks 4, 8, and 12 from baseline
Proportion of patients with urine leakage ≥ 50%
Proportion of patients with urine leakage ≥ 50% on the standardized pad test at Week 12 compared with baseline.
Measured: at Weeks 12.
Proportion of patients with urine leakage ≥ 75%
Proportion of patients with urine leakage ≥ 75% on the standardized pad test at Week 12 compared with baseline.
Measured: at Weeks 12.
Change and percent change from baseline in the mean the standardized pad test
Change and percent change from baseline in the mean the standardized pad test result (urine leakage amount) at Weeks 4 and 12
Measured: at Weeks 4 and 12.
Change and percent change from baseline in the average number of urinary incontinence episodes
Change and percent change from baseline in the average number of urinary incontinence episodes recorded over a 3-day period at Week 12
Measured: at Weeks 12.
Change and percent change from baseline in the total and subscale scores
Change and percent change from baseline in the total and subscale scores of the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI-SF) at Weeks 4, 8, and 12
Measured: at Weeks 4, 8, and 12 from baseline
Change and percent change from baseline in the total and subscale scores
Change and percent change from baseline in the total and subscale scores of the Incontinence Quality of Life questionnaire (I-QoL) at Week 12
Measured: 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
Change and percent change from baseline in the Patient Perception of Intensity of Urgency Scale (PPIUS; 5-point scale) score at Weeks 4, 8, and 12
Measured: at Weeks 4, 8, and 12 from baseline
Pelvic floor muscle assessment
Proportion of participants showing improvement from baseline in pelvic floor muscle contraction on the Oxford scale at Week 12.
Measured: at week 12 from baseline
Intravaginal pressure assessment
Change from baseline and percent change in intravaginal pressure at Week 12
Measured: at week 12 from baseline
Patient Global Impression of Improvement (PGI-I)
Patient Global Impression of Improvement (PGI-I) at Week 12 compared with baseline
Measured: at week 12 from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start13 Dec 2024
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary Incontinence (SUI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ceragem Clinical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyu Sung Lee, MD, Principal investigator, Samsung Seoul Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07440927
- Sponsor's protocol ID
- CC_UIT_307
- Status last verified
- Feb 2026
- First submitted
- 2 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided