Prospective study evaluating efficacy and safety of Adjustable Continence Therapy (ProACT) for post radical prostatectomy urinary incontinence.

OBJECTIVES: To examine a new prosthesis, the Adjustable Continence Therapy (ProACT), to determine its ability to treat effectively post radical prostatectomy urinary incontinence. Urinary incontinence is one of the most significant complications of radical prostatectomy. Although the artificial urinary sphincter (AUS) is considered the standard treatment for this condition, many men seek a simpler and less expensive treatment option.

METHODS: From November 2000 to March 2004, 25 patients with severe post radical prostatectomy urinary incontinence were treated using the ProACT device. The preoperative evaluation included pad count, Valsalva leak point pressure determination, and Incontinence Quality-of-Life scores. In the follow-up, the same parameters, as well as complications, were analyzed and compared with the baseline measurements to assess the efficacy.

RESULTS: The follow-up period was 6 to 48 months (mean 22.4). Of the 25 patients, 23 had follow-up data available for analysis. The improvements in pad count, Incontinence Quality-of-Life score, and Valsalva leak point pressures from baseline to the last follow-up examination were all significant (P <0.05). Overall, of the 23 patients followed up, 15 (65.2%) were continent using 0 to 1 pad daily and satisfied, 3 (13%) were improved but unsatisfied, and 5 (22%) did not have any improvement. Balloon adjustments were performed in all patents to achieve continence. Revision surgery was required in 4 (17%) of 23 patients.

CONCLUSIONS: The use of ProACT represents a safe and effective treatment for post radical prostatectomy incontinence with a good degree of patient satisfaction and a low complication rate. Postoperative adjustments were necessary in most patients and were undertaken as a simple outpatient visit.