Safety and Performance of UCon Bar Electrode for the Treatment of Overactive Bladder (OAB) and Bowel Dysfunction (BD) - An Early Feasibility Study
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.
• OAB: Urinary urgency usually with one or more of the following:
• i. Urinary urgency incontinence (≥1 per/week). ii. Urinary frequency (≥8 voiding/day without polyuria). iii. Nocturia (≥2 voiding/night without nocturnal polyuria).
• BD: One or more of the following:
• i. Faecal urgency (≥3 urgencies pr. week) together with registration of urgency in St. Mark´s and a St. Mark´s score ≥9.
• ii. Faecal incontinence (urge/passive) (≥1 per/week).
• Participant is able to communicate, provide feedback, understand and follow instructions during the course of the investigation, including using the device at home.