UCon Treatment of Overactive Bladder (OAB) in Males

Launched by INNOCON MEDICAL · May 23, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called UCon for men who experience symptoms of overactive bladder (OAB), such as frequent urination, sudden urges to urinate, and waking up at night to use the bathroom. UCon is a medical device that sends gentle electrical signals through the skin to help control bladder activity and improve symptoms. The trial aims to assess how safe the device is and how well it works in a small group of male participants aged 18 and older who have been diagnosed with OAB.

To be eligible for this trial, participants must be men aged 18 or older who can understand and follow instructions. However, those with certain health conditions, such as infections or active medical devices like pacemakers, may not qualify. Participants will have the opportunity to try UCon and provide feedback about their experience. It's important to note that the trial is currently recruiting participants, so those interested should consider reaching out for more information.

Gender

MALE

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.