Actively Recruiting
UCon Treatment of Overactive Bladder (OAB) in Males
Led by InnoCon Medical · Updated on 2025-10-01
20
Participants Needed
1
Research Sites
139 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
UCon Treatment of Overactive Bladder (OAB) in Males
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject is 18 years of age or older.
- Subject is male.
- Subject is diagnosed with overactive bladder (OAB).
- Subject is able to communicate, provide feedback, and follow instructions during the study.
You will not qualify if you...
- Subject is medically unstable due to acute illness or complications of a chronic condition.
- Subject has a post void residual (PVR) volume over 100 ml or bladder voiding efficiency (BVE) under 75%.
- Subject has an active infection in the genital area, including skin or urinary tract infections.
- Subject has had botulinum toxin (BOTOX) treatment in the pelvic region within the past 6 months.
- Subject has used antimuscarinics or beta-3 agonists within 14 days before baseline unless a 14-day washout period is observed.
- Subject has an implanted pacemaker, implantable drug pump, or other active electrical medical device.
- Subject is currently or planning to be enrolled in another clinical investigation or was enrolled within 4 weeks prior.
- Subject has neuropathy that may reduce the effect of electrical stimulation.
- Subject has a history of pelvic region cancer, current cancer treatment, or radiation damage to the pelvic area.
- Subject has addictive behavior involving alcohol, cannabis, opioids, or other intoxicating drugs.
- Subject does not speak or understand Dutch.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Maastricht University Medical Center+
Maastricht, Netherlands
Actively Recruiting
Research Team
D
Dianna Mærsk Knudsen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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