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RECRUITING
NCT05874375
NA

UCon Treatment of Overactive Bladder (OAB) in Males

Sponsor: InnoCon Medical

View on ClinicalTrials.gov

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

Interventions

DEVICE

Urge stimulation

Participants will receive stimulation for 60 seconds, when they feel an urgency.

DEVICE

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