The artificial urinary sphincter with a pressure regulating balloon was implanted in 30 patients. All implantations were done before September 1982, for a minimum followup of 1 year and an average followup of 3.7 years. Of the patients 21 (70 per cent) have a functioning sphincter: 17 are continent and 4 are slightly incontinent, requiring 1 pad per day. Failure was owing to erosion in 6 patients and infection of the device in 3. Critical factors for successful implantation include preoperative evaluation, cuff location and pressure, primary deactivation and postoperative care. Our experience supports the further use of this device in appropriate cases.