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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
96
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.
Samsung Seoul Hospital
Seoul, South Korea
RECRUITINGProportion 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.
Time frame: at week 12 compared with baseline.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: at Weeks 12.
Change and percent change from baseline in the total and subscale scores
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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
Time frame: 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
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
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
Time frame: 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.
Time frame: at week 12 from baseline
Intravaginal pressure assessment
Change from baseline and percent change in intravaginal pressure at Week 12
Time frame: 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
Time frame: at week 12 from baseline