UCon Treatment of Overactive Bladder (OAB) in Males

Exclusion Criteria12

• Subject is medically unstable (acute illness or complications of a chronic condition that might affect the subject's participation in the investigation).
• 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)).
• Subject has an active infection in the genital area incl. skin infections and urinary tract infection.
• Subject has had botulinum toxin (BOTOX) treatment in the pelvic region within 6 months.
• Subject has used antimuscarinics or β3 agonists within 14 days weeks*.
• 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).
• 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.
• Subject has neuropathy to a degree that is presumed to diminish the effect of the electrical stimulation.
• Subject has a history of cancer in the pelvic region, are currently receiving cancer treatment, or has radiation-induced damage to the pelvic region.
• Subject has addictive behaviour defined as abuse of alcohol, cannabis, opioids, or other intoxicating drugs.
• 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.