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
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This study is a multicenter, prospective, randomized, double-blind, sham-controlled clinical trial conducted in female patients with stress urinary incontinence.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 19
Healthy Volunteers: f
View:
• Patients with urine leakage of ≥1 g on the standardized pad test
Locations
Other Locations
Republic of Korea
Samsung Seoul Hospital
RECRUITING
Seoul
Contact Information
Primary
Myeongbae Shin, Researcher
mbshin94@ceragem.com
82-10-4373-2808
Time Frame
Start Date: 2024-12-13
Estimated Completion Date: 2026-09-30
Participants
Target number of participants: 96
Treatments
Experimental: Non-implantable neuromuscular electrical stimulation (NMES) group
Non-implantable neuromuscular electrical stimulation (NMES) group for urinary incontinence
Sham_comparator: Comparator device group
Non-implantable neuromuscular electrical stimulation (NMES) without electrical stimulation group for urinary incontinence
Related Therapeutic Areas
Sponsors
Leads: Ceragem Clinical Inc.