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This study is a multicenter, prospective, randomized, double-blind, sham-controlled clinical trial conducted in female patients with stress urinary incontinence.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-implantable neuromuscular electrical stimulation (NMES) group | Experimental | Non-implantable neuromuscular electrical stimulation (NMES) group for urinary incontinence |
|
| Comparator device group | Sham Comparator | Non-implantable neuromuscular electrical stimulation (NMES) without electrical stimulation group for urinary incontinence |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. |
| 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% |
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Inclusion Criteria:
Exclusion Criteria:
female patient with stress urinary incontinence
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Myeongbae Shin, Researcher | Contact | 82-10-4373-2808 | mbshin94@ceragem.com |
| Name | Affiliation | Role |
|---|---|---|
| Kyu Sung Lee, MD | Samsung Seoul Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Seoul Hospital | Recruiting | Seoul | South Korea |
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| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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|
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 |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |