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

This study is a multicenter, prospective, randomized, double-blind, sham-controlled clinical trial conducted in female patients with stress urinary incontinence.

Study Overview

• Status: Recruiting
• Conditions: Stress Urinary Incontinence (SUI)
• Intervention / Treatment: Device: Ceragem Innerfit medi-tech

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 Type: Interventional
• Enrollment (Estimated): 96
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Myeongbae Shin, Researcher; Phone Number: 82-10-4373-2808; Email: mbshin94@ceragem.com

Study Locations

• South Korea
  • Seoul, South Korea
    • Recruiting
    • Samsung Seoul Hospital
    • Contact: Kyu sung Lee, MD; Phone Number: 82-2-3410-0200

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Non-implantable neuromuscular electrical stimulation (NMES) group; Non-implantable neuromuscular electrical stimulation (NMES) group for urinary incontinence	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.
Sham Comparator: Comparator device group; Non-implantable neuromuscular electrical stimulation (NMES) without electrical stimulation group for urinary incontinence	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	at week 12 compared with baseline.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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	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	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	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	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	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.	at week 12 from baseline
Intravaginal pressure assessment	Change from baseline and percent change in intravaginal pressure at Week 12	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	at week 12 from baseline

Collaborators and Investigators

• Sponsor: Ceragem Clinical Inc.
• Investigators: Principal Investigator: Kyu Sung Lee, MD, Samsung Seoul Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: February 2, 2026
• First Submitted That Met QC Criteria: February 25, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 25, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Stress Urinary Incontinence (SUI)
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Incontinence; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Urinary Incontinence, Stress
• Other Study ID Numbers: CC_UIT_307

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No