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UCon Treatment of Overactive Bladder (OAB) in Males
Sponsor: InnoCon Medical
Summary
UCon is a medical device for treatment of the symptoms of OAB and fecal incontinence (FI). It electrically stimulates the DGN through the skin to obtain modulated behaviour of the bladder musculature e.g., suppress undesired bladder activity to relieve the symptoms of the patient. This clinical investigation is a randomized, cross-over, single-site, prospective, early feasibility study, which is used to evaluate Ucon with respect to its initial clinical safety and device performance in a small number of males with OAB.
Official title: Safety and Performance of UCon for Management of Non-Neurogenic OAB in Males - An Early Feasibility Study
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2023-10-12
Completion Date
2026-06-12
Last Updated
2025-10-01
Healthy Volunteers
No
Conditions
Interventions
Urge stimulation
Participants will receive stimulation for 60 seconds, when they feel an urgency.
Time limited stimulation
Participant will receive the stimulation as provided in time limited sessions (Range: 15 min - continuous), whenever it suits the participant during the day.
Locations (1)
Maastricht University Medical Center+
Maastricht, Netherlands