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.
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Incidence of serious adverse device effects (SADEs).
Timeframe: At 12 weeks.
Ratio of treatment change [performance] of OAB symptoms.
Timeframe: Change from baseline at 6 weeks.
Ratio of treatment change [performance] of BD symptoms.
Timeframe: Change from baseline at 6 weeks.