ABSTRACT
PURPOSE: We determined the functional results and morbidity of balloon (ProACT™) implants for the treatment of male stress urinary incontinence after prostate surgery. MATERIALS AND METHODS: Between 2002 and 2008 a prospective, noncontrolled study was conducted. The ProACT implant consists of 2 adjustable balloons placed on either side of the native striated sphincter. The implants are adjusted by inflation during followup visits. The primary efficacy end point was postoperative continence as defined by the use of 0 to 1 pad daily. RESULTS: A total of 128 consecutive patients underwent implantation. Mean ± SD patient age was 71 ± 42.3 years (range 52 to 87). The severity of incontinence before ProACT was moderate (71), mild (40) and severe (17). Overall 25% of patients previously underwent pelvic radiotherapy. The mean number of daily pads per patient was 1.46 (vs 4.2 at baseline). Mean followup was 56.3 months (range 24 to 95). The functional result was success in 68% of patients with moderate/mild incontinence and the explantation rate was 18%. Among the 30 patients treated with radiotherapy before ProACT the success rate was only 46% and the incidence of urethral erosion was significantly higher (p = 0.005). CONCLUSIONS: The ProACT implant appears to be an option for the treatment of moderate male stress urinary incontinence, especially given the minimally invasive modalities of insertion, the capacity to adjust the inflation of the balloons to achieve postoperative continence and the relative reversibility.
