Treatment for Overactive Bladder in Men
Safety and Performance of UCon for Management of Non-Neurogenic OAB in Males - An Early Feasibility Study
This study is testing a new device that uses electrical stimulation to see if it can help men with overactive bladder feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | InnoCon Medical Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 1 site (Maastricht) |
| Trial ID | NCT05874375 on ClinicalTrials.gov |
What this trial studies
This clinical investigation evaluates the UCon medical device, which electrically stimulates the dorsal genital nerve to alleviate symptoms of overactive bladder (OAB) in males. The study is designed as a randomized, cross-over, single-site, prospective, early feasibility trial to assess the initial clinical safety and performance of UCon. Participants will receive either urge stimulation or time-limited stimulation to determine the most effective approach for managing OAB symptoms. The study aims to gather feedback from participants to optimize treatment strategies.
Who should consider this trial
Good fit: Ideal candidates for this study are adult males aged 18 and older who have been diagnosed with overactive bladder.
Not a fit: Patients with certain medical conditions, such as active infections or those who have recently received specific treatments, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for men suffering from overactive bladder symptoms.
How similar studies have performed: While this approach is innovative, similar studies using neurostimulation for bladder control have shown promise, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Maastricht
- Maastricht University Medical Center+ — Maastricht, Netherlands (Recruiting)
Study contacts
- Principal investigator: John Heesakkers, MD — Maastricht UMC+, P. Debyelaan 25, 6229 HX Maastricht, The Netherlands
- Study coordinator: Dianna Mærsk Knudsen
- Email: dmk@innoconmedical.dk
- Phone: 40517712
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.