Evaluating Safety and Effectiveness of UCon Patch Electrode for Overactive Bladder and Bowel Dysfunction Treatment in Adults

What this Trial Is About

Researchers are evaluating the UCon medical device, which uses electrical stimulation through a patch electrode to treat symptoms of overactive bladder OAB and bowel dysfunction BD. This pivotal clinical investigation aims to confirm the safety and performance of the UCon device in 180 patients over 12 weeks, comparing active stimulation with a sham device to better understand symptom improvement and safety. Participants take part in a 12-week intervention period. For the first 6 weeks, they are randomly assigned in a 21 ratio to either the treatment group receiving actual Time Limited electrical stimulation to the dorsal genital nerve using the UCon-Patch electrode or the sham group receiving sham stimulation believed not to affect symptoms. During weeks 7 to 12, the treatment group may add urge stimulation to the Time Limited stimulation, while the sham group switches to the Time Limited stimulation. Throughout the study, participants self-administer daily 30-minute stimulation sessions at home. Researchers assess safety by tracking serious adverse device effects and adverse events over 12 weeks. They also measure changes in urinary and bowel symptoms, including urgency urinary incontinence and fecal incontinence, using questionnaires and symptom episode counts at baseline, 6 weeks, and 12 weeks. The study evaluates both short- and longer-term effects of the device.

Safety and Performance of UCon Patch Electrode