NCT05874375 UCon Treatment of Overactive Bladder (OAB) in Males
| NCT ID | NCT05874375 |
| Status | Recruiting |
| Phase | — |
| Sponsor | InnoCon Medical |
| Condition | Urinary Incontinence |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2023-10-12 |
| Primary Completion | 2026-06-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2023-10-12 with a primary completion date of 2026-06-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: 1. Subject is ≥ 18 years of age. 2. Subject is male. 3. Subject is diagnosed with OAB 4. Subject is able to communicate, provide feedback, understand and follow instructions during the course of the investigation. Exclusion Criteria: 1. Subject is medically unstable (acute illness or complications of a chronic condition that might affect the subject's participation in the investigation). 2. Subject has a Post Void Residual (PVR) of more than 100 ml or a Bladder Voiding Efficiency (BVE) of less than 75% (measured by uroflowmetry as the ratio of voided volume (VV) and total bladder capacity (VV+PVR)). 3. Subject has an active infection in the genital area incl. skin infections and urinary tract infection. 4. Subject has had botulinum toxin (BOTOX) treatment in the pelvic region within 6 months. 5. Subject has used antimuscarinics or β3 agonists within 14 days weeks\*. 6. Subject has an implanted pacemaker, implantable drug pump or other active medical device (any medical device that uses electrical energy or other source of power to make it function). 7. Subject is enrolled or planning to enrol in another clinical investigation or was enrolled in an investigational drug study or medical device investigation within four weeks to enrolment. 8. Subject has neuropathy to a degree that is presumed to diminish the effect of the electrical stimulation. 9. Subject has a history of cancer in the pelvic region, are currently receiving cancer treatment, or has radiation-induced damage to the pelvic region. 10. Subject has addictive behaviour defined as abuse of alcohol, cannabis, opioids, or other intoxicating drugs. 11. Subject does not speak and understand Dutch. * If a subject is currently being treated with antimuscarinics or β3 agonists, he is allowed to be included in the investigation, however, a washout period of 14 days is required before baseline can be established.
Contact & Investigator
John Heesakkers, MD
PRINCIPAL INVESTIGATOR
Maastricht UMC+, P. Debyelaan 25, 6229 HX Maastricht, The Netherlands
Frequently Asked Questions
Who can join the NCT05874375 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Urinary Incontinence. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05874375 currently recruiting?
Yes, NCT05874375 is actively recruiting participants. Contact the research team at dmk@innoconmedical.dk for enrollment information.
Where is the NCT05874375 trial being conducted?
This trial is being conducted at Maastricht, Netherlands.
Who is sponsoring the NCT05874375 clinical trial?
NCT05874375 is sponsored by InnoCon Medical. The principal investigator is John Heesakkers, MD at Maastricht UMC+, P. Debyelaan 25, 6229 HX Maastricht, The Netherlands. The trial plans to enroll 20 participants.