Stress Urinary Incontinence (SUI)
Conditions
Keywords
Stress Urinary Incontinence (SUI)
Brief summary
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.
Interventions
DEVICECeragem 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.
Sponsors
Ceragem Clinical Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with urine leakage <1 g | 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
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with urine leakage <1 g | 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. |
| Proportion of patients with urine leakage ≥ 50% | at Weeks 12. | Proportion of patients with urine leakage ≥ 50% on the standardized pad test at Week 12 compared with baseline. |
| Proportion of patients with urine leakage ≥ 75% | at Weeks 12. | Proportion of patients with urine leakage ≥ 75% on the standardized pad test at Week 12 compared with baseline. |
| Change and percent change from baseline in the mean the standardized pad test | 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 |
| Change and percent change from baseline in the average number of urinary incontinence episodes | 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 |
| Change and percent change from baseline in the total and subscale scores | 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 |
| 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 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 |
| Pelvic floor muscle assessment | at week 12 from baseline | Proportion of participants showing improvement from baseline in pelvic floor muscle contraction on the Oxford scale at Week 12. |
| Intravaginal pressure assessment | at week 12 from baseline | Change from baseline and percent change in intravaginal pressure at Week 12 |
| Patient Global Impression of Improvement (PGI-I) | at week 12 from baseline | Patient Global Impression of Improvement (PGI-I) at Week 12 compared with baseline |
Countries
South Korea
Contacts
CONTACTMyeongbae Shin, Researcher
PRINCIPAL_INVESTIGATORKyu Sung Lee, MD
Samsung Seoul Hospital
Outcome results
None listed