Treatment of Postprostatectomy Stress Urinary Incontinence Using a Minimally Invasive Adjustable Continence Balloon Device, ProACT: Results of a Preliminary, Multicenter, Pilot Study

Objectives To evaluate the safety and efficacy of a new minimally invasive device, Adjustable Continence Therapy (ProACT) for patients with postprostatectomy stress urinary incontinence (SUI). Methods Sixty-two patients with urodynamic SUI after prostate surgery were evaluated according to daily pad count and a specific validated evaluation for persons with urinary incontinence. Results All patients were successfully implanted in a single procedure using general or spinal anaesthesia. Procedural time was 37 minutes (range, 18 to 80 minutes). Daily pad usage decreased from 4.6 pads per day to 1.06 pads per day at 12 months. Mean quality-of-life index score increased from 48 to 67 at 12 months.Fifty-nine percent of patients without adjuvant radiation were improved (greater than 50% reduction in pad use), and 30% were cured (no pads), whereas 83% of postirradiated patients failed intervention. Fifty-five patients (88%) required percutaneous balloon adjustments. The mean optimal volume after adjustments for all 45 improved patients was 3.8 mL per balloon. Complications necessitating removal occurred in 19 patients and included erosion, infection, migration, and failure to respond. Of these, 4 were successfully reimplanted. All complications occurred in the first postoperative month. Conclusions Implantation of postoperatively adjustable balloons in postprostatecomy men is technically feasible, with an improvement in continence particularly in patients with nonirradiated periurethral tissues. Optimal urethral resistance is achieved, with easy postoperative adjustment. Implantation of ProACT balloons may represent a promising development in the treatment of postprostatectomy SUI.