To evaluate the functional results, morbidity, and quality of life of the adjustable continence balloons ProACT for the treatment of male stress urinary incontinence after prostate surgery considering both short- and long-term results.

Between 2002 and 2012, twenty-two consecutive male patients were implanted with the ProACT device. Continence was defined by the use of 0 pads daily, and the quality of life was assessed by validated questionnaires.

Only 1 patient (4.5%) was immediately continent after ProACT implantation, and the other 21 men (95.5%) needed ≥1 balloon refillments postoperatively. The baseline daily pad number decreased from a mean of 5.9 pads (range, 3-12 pads) to a mean of 1.7 pads (range, 0-5 pads) per day after refilling but increased to a mean of 3.9 (range, 0-10) at the last follow-up visit. After balloon adjustments, 4 patients (18%) were continent and 18 patients (82%) showed an improvement with a 95% rate of subjective satisfaction. Revision and explantation rates were 73% and 55%, respectively. At a median follow-up of 57 months, only 1 patient (4.5%) remained dry, and only 10 patients (45%) remained satisfied with the procedure, whereas 12 patients (55%) were unchanged and dissatisfied.

The ProACT device appears to be safe and efficacious in the short term. The postoperative readjustment allows the achievement of a short-term continence status. However, on the long term, the ProACT does not appear to be an ideal device for durable continence and patients' satisfaction.