UCon Treatment of Overactive Bladder (OAB) in Males (NCT05874375) | Clinical Trial Compass
RecruitingNot Applicable
UCon Treatment of Overactive Bladder (OAB) in Males
Netherlands20 participantsStarted 2023-10-12
Plain-language 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.
Who can participate
Age range18 Years
SexMALE
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Inclusion criteria
✓. Subject is ≥ 18 years of age.
✓. Subject is male.
✓. Subject is diagnosed with OAB
✓. Subject is able to communicate, provide feedback, understand and follow instructions during the course of the investigation.
Exclusion criteria
✕. 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.
What they're measuring
1
PRIMARY SAFETY: To evaluate adverse events [initial safety] of UCon for treatment of OAB symptoms in a home setting.
Timeframe: After 44 days (end of study)
2
PRIMARY PERFORMANCE: To evaluate the ratio of treatment change [performance] of OAB symptoms using UCon in a home setting
Timeframe: Change from baseline at 14 days, 30 days and 44 days (study end)