The overall purpose of the current clinical investigation is to evaluate the medical device (UCon) with respect to initial safety and device performance in a cohort of Spanish patients with FI over a treatment period of 4 weeks.
UCon is a medical device for treatment of the symptoms of overactive bladder and fecal incontinence (FI). 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, single-centre, early feasibility study.