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NCT Number: NCT07440927

Stress Urinary Incontinence for Female Patients (CGM MUIT-2301)

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

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Key information

Conditions

Stress Urinary Incontinence (SUI) Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urinary Incontinence, Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

19 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Samsung Seoul Hospital

Seoul, South Korea

Location status: Recruiting

Location contact

Kyu sung Lee, MD

CONTACT

82-2-3410-0200

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ceragem Innerfit medi-tech

Device

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 outcomes

  1. 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.

Secondary outcomes

  1. Proportion of patients with urine leakage <1 g

    Time frame: at Weeks 4, 8, and 12 from baseline

    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.

  2. Proportion of patients with urine leakage ≥ 50%

    Time frame: at Weeks 12.

    Proportion of patients with urine leakage ≥ 50% on the standardized pad test at Week 12 compared with baseline.

  3. Proportion of patients with urine leakage ≥ 75%

    Time frame: at Weeks 12.

    Proportion of patients with urine leakage ≥ 75% on the standardized pad test at Week 12 compared with baseline.

  4. 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 mean the standardized pad test result (urine leakage amount) at Weeks 4 and 12

  5. 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 average number of urinary incontinence episodes recorded over a 3-day period at Week 12

  6. 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 of the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI-SF) at Weeks 4, 8, and 12

  7. 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 total and subscale scores of the Incontinence Quality of Life questionnaire (I-QoL) at Week 12

  8. 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

    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

  9. Pelvic floor muscle assessment

    Time frame: at week 12 from baseline

    Proportion of participants showing improvement from baseline in pelvic floor muscle contraction on the Oxford scale at Week 12.

  10. Intravaginal pressure assessment

    Time frame: at week 12 from baseline

    Change from baseline and percent change in intravaginal pressure at Week 12

  11. Patient Global Impression of Improvement (PGI-I)

    Time frame: at week 12 from baseline

    Patient Global Impression of Improvement (PGI-I) at Week 12 compared with baseline

Study contacts

Contact information is provided by the study sponsor or research team.

Myeongbae Shin, Researcher

CONTACT

[email protected]

82-10-4373-2808

Sponsors and collaborators

Lead sponsor

Ceragem Clinical Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 27, 2026
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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