RecruitingNot ApplicableNCT05874375

UCon Treatment of Overactive Bladder (OAB) in Males

Safety and Performance of UCon for Management of Non-Neurogenic OAB in Males - An Early Feasibility Study


Sponsor

InnoCon Medical

Enrollment

20 participants

Start Date

Oct 12, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Time limited stimulation and a medical device called Urge stimulation for people with incontinence, nighttime urinary, nocturia, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include men aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEUrge stimulation

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

DEVICETime 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

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NCT05874375


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