Treatment for Overactive Bladder in Men

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Evaluating a new device for treating overactive bladder and bowel dysfunction

  This study is testing a new device that uses electrical stimulation to see if it can help people with overactive bladder and bowel issues feel better.

  Recruiting at 3 sites InnoCon Medical · Aarhus and 2 other locations · NCT06754189

• Treatment of Overactive Bladder and Bowel Dysfunction with UCon Bar Electrode

  This study is testing a new device to see if it can help women with overactive bladder and bowel issues feel better by using electrical stimulation.

  Recruiting at 3 sites InnoCon Medical · Aarhus and 2 other locations · NCT06091566

• Comparing bladder therapies for older women with urinary incontinence

  This study is testing whether two different bladder treatments can help older women with urinary incontinence feel better compared to a placebo.

  Recruiting at 2 sites Phase 4 University of California, San Francisco · Palo Alto, California and 1 other locations · NCT05362292

• Comparing pain from different numbers of bladder injections of Botox

  This study is testing whether getting 5 or 20 Botox injections for overactive bladder causes more pain in women who haven't found relief from other treatments.

  Recruiting at 2 sites Phase 4 University of South Florida · Washington D.C., District of Columbia and 1 other locations · NCT04305743

• Compare two bladder medicines and placebo for urgency incontinence in older women

  This study tests whether tolterodine ER or mirabegron help with urinary and aging-related outcomes in older women with urgency-predominant incontinence, compared with placebo.

  Recruiting Phase 4 University of California, San Francisco · San Francisco, California · NCT07829029

• Urinary incontinence in older adults: how leakage and bladder residuals relate to frailty

  This study tests whether the severity of urinary leakage and leftover urine after voiding are linked to frailty and other geriatric outcomes in older adults visiting a urology clinic.

  Recruiting Karabuk University · Karabük, Merkez · NCT07813702

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.