An adjustable continence therapy device for treating incontinence after prostatectomy: a minimum 2-year follow-up.

OBJECTIVE: To evaluate the efficacy and safety of the ProACT (Uromedica, Inc., MN, USA) balloon device, an alternative for the surgical management of incontinence after prostatectomy. PATIENTS AND METHODS: The initial patients who received this device at our institution were evaluated, using urodynamics at baseline and at 6 months. Perioperative variables were recorded and pad usage, volume adjustments, an estimate of Incontinence Quality of Life (I-QoL) and adverse events were recorded at baseline, and 1, 3, 6, 12 and 24 months after surgery. RESULTS: In all, 37 patients were treated on this protocol between November 2001 and March 2005. Of these, 30 had had radical prostatectomy and seven holmium laser enucleation of the prostate. The mean (range) pad usage decreased from 2.81 (1-12) at baseline to 0.7 (0-4) pads at 24 months, and the I-QOL increased from 49.7 (4.5-77) to 81.3 (13.6-100) over the same period. At 24 months, 62% of 34 men were pad-free and 81% required one pad or less. Bilateral explantation was required in three patients (11%) for infection (one) and balloon migration (two). All other adverse events were mild and transient. CONCLUSIONS: The ProACT balloon device is an acceptable therapy for the surgical management of incontinence after prostatectomy.