UCon is a medical device for treatment of the symptoms of OAB and fecal incontinence (FI). It electrically stimulates the DGN through the skin to obtain modulated behaviour of the bladder musculature e.g., suppress undesired bladder activity to relieve the symptoms of the patient. This clinical investigation is a randomized, cross-over, single-site, prospective, early feasibility study, which is used to evaluate Ucon with respect to its initial clinical safety and device performance in a small number of males with OAB.
Subject is ≥ 18 years of age.
Subject is male.
Subject is diagnosed with OAB
Subject is able to communicate, provide feedback, understand and follow instructions during the course of the investigation.
Subject is medically unstable (acute illness or complications of a chronic condition that might affect the subject's participation in the investigation).
Subject has a Post Void Residual (PVR) of more than 100 ml or a Bladder Voiding Efficiency (BVE) of less than 75% (measured by uroflowmetry as the ratio of voided volume (VV) and total bladder capacity (VV+PVR)).
Subject has an active infection in the genital area incl. skin infections and urinary tract infection.
Subject has had botulinum toxin (BOTOX) treatment in the pelvic region within 6 months.