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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07440927
- Acronym / sponsor ID
- CC_UIT_307
- Conditions
- Stress Urinary Incontinence (SUI)
- Keywords
- Stress Urinary Incontinence (SUI)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Ceragem Clinical Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Dec 2024 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-implantable neuromuscular electrical stimulation (NMES) group | Experimental | Device: Ceragem Innerfit medi-techNon-implantable neuromuscular electrical stimulation (NMES) group for urinary incontinence |
| Comparator device group | Sham comparator | Device: Ceragem Innerfit medi-techNon-implantable neuromuscular electrical stimulation (NMES) without electrical stimulation group for urinary incontinence |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with urine leakage of ≥1 g on the standardized pad test
Key exclusion criteria (3 listed)
- Patients with mixed urinary incontinence with predominant urgency urinary incontinence
- Patients with stress urinary incontinence
- Patients with overflow urinary incontinence
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ceragem Innerfit medi-techStress 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. | Device | Comparator device group, Non-implantable neuromuscular electrical stimulation (NMES) group |
Primary outcome
Proportion of patients with urine leakage <1 g
Time frame: at week 12 compared with baseline.
Proportion of patients with urine leakage <1 g on the standardized pad test at Week 12 compared with baseline.
11 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kyu Sung Lee, MD principal investigator
Samsung Seoul Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Myeongbae Shin, Researcher (82-10-4373-2808, mbshin94@ceragem.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with urine leakage <1 g (time frame: at week 12 compared with baseline.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.