UCon is a medical device for treatment of the symptoms of overactive bladder (OAB) and bowel dysfunction (BD). It electrically stimulates the DGN through the skin to obtain modulated behaviour of the bladder/bowel musculature e.g., suppress undesired bladder/bowel activity to relieve the symptoms of the patient.
This clinical investigation is designed as a single-arm, prospective, multi-centre, and early feasibility study.
Participant is female
Participant is ≥ 18 years of age.
Participant is diagnosed with OAB or BD.
Participant is able to communicate, provide feedback, understand and follow instructions during the course of the investigation, including using the device at home.
Participant is medically unstable (acute illness or complication of a chronic condition, apart from the OAB or BD, that might affect the participants´ participation in the investigation).
Participant has an active infection in the genital area.
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).
Participant is pregnant, nursing or planning a pregnancy (to be confirmed with a negative pregnancy test). Women of childbearing potential must maintain effective contraception during the clinical investigation.
InnoCon Medical
Lead sponsor
Aarhus University Hospital
Collaborator
Odense University Hospital
Collaborator
Herlev Hospital
Collaborator