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.
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).
InnoCon Medical
Lead sponsor
Aarhus University Hospital
Collaborator
Odense University Hospital
Collaborator
Herlev Hospital
Collaborator