Trial Parameters
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Participant has genital anatomy that does not allow for proper electrode placement or stimulation of the DGN. * Participant has an active infection in the genital area, including skin infections. * Participant has injured or irritated skin in the genital area, where the electrode is placed. * Participant is medically unstable (acute illness or complication of a chronic condition, apart from the OAB or BD, that might affect the participant's participation in the investigation). * Participant has an implanted pacemaker, implantable drug pump or other active medical devices (any medical device that uses electrical energy or other sources of power to make it function). * Partic