Safety and Performance of UCon Patch Electrode for the Treatment of Overactive Bladder (OAB) and Bowel Dysfunction (BD) - A Pivotal Clinical Investigation
UCon is a medical device for treating the symptoms of overactive bladder (OAB) and bowel dysfunction (BD). It electrically stimulates the DGN through the skin to obtain modulated behavior of the bladder/bowel musculature e.g., suppressing undesired bladder/bowel activity to relieve the symptoms of the patient. This pivotal clinical investigation is designed as a stratified-randomized, single-blinded, controlled, confirmatory, prospective, multicenter clinical investigation.
• Participant is ≥ 18 years of age.
• Participant is diagnosed with OAB or BD.
• Participant is able to consent, communicate, provide feedback, and understand and follow instructions in Danish during the course of the investigation, including operation of the device at home.