Evaluating Safety and Effectiveness of UCon Bar Electrode for Treating Overactive Bladder and Bowel Dysfunction in Women

What this Trial Is About

Researchers are evaluating the UCon medical device with a Bar Electrode for treating symptoms of overactive bladder OAB and bowel dysfunction BD in female patients. This early feasibility clinical investigation aims to assess both the initial safety and performance of the device in a group of 40 women over 12 weeks. The UCon device electrically stimulates the dorsal genital nerve DGN through the skin to help manage bladder and bowel muscle activity and relieve symptoms. The study includes two main periods screening and intervention. During the screening phase, participants use the UCon device with a Patch Electrode at home for 4 weeks to determine eligibility for the next phase. In the intervention period, the Bar Electrode is inserted into the clitoral hood, followed by a recovery time of 4 to 8 weeks. After recovery, participants self-administer electrical stimulation using the Bar Electrode at home for either 4 or 12 weeks. Participants will be closely monitored throughout the study with assessments of device safety, proper electrode insertion, and symptom changes at 4 and 12 weeks. Researchers will evaluate treatment effects on OAB and BD symptoms, quality of life, and user acceptance of the device. Safety monitoring includes tracking adverse events, and participants will provide feedback during the study. The total study duration for each participant includes screening, recovery, and intervention phases.

Safety and Performance of UCon Bar Electrode for the Treatment of Overactive Bladder (OAB) and Bowel Dysfunction (BD)