An adjustable male sling for treating urinary incontinence after prostatectomy: a phase III multicentre trial.

OBJECTIVE To evaluate the efficacy and safety of a new adjustable bulbourethral sling (Argus, Promedon SA, Cordoba, Argentina) in the treatment of male stress urinary incontinence (SUI) after prostate surgery. PATIENTS AND METHODS In all, 48 patients with SUI because of prostatic surgery for prostate cancer (39) or benign prostatic hyperplasia (nine) had a new sling implanted in a multicentre trial at six institutions between April 2003 and September 2004. All patients were fully evaluated, including a questionnaire (International Consultation on Incontinence Questionnaire-Short Form, ICIQ-SF, range 0-21), endoscopy, and urodynamic evaluation. The Argus system comprises a 4.2 x 2.6 x 0.9 cm thick silicone foam pad for soft bulbar urethral compression. The pad is attached to the silicone cone columns that, after being passed with needles from the perineum to the abdominal wall, are adjusted with silicone washers to regulate and keep the desired tension against the urethra. The pad and washers are radio-opaque, which allows their position to be assessed during follow-up. The surgical technique was one described previously, with some modifications. RESULTS At a mean (range) follow-up of 7.5 (1-17.5) months, 35 (73%) of the 48 patients were dry, five (10%) were improved, and eight (17%) were incontinent, including four (8%) who needed sling adjustment. The mean (range) ICIQ-SF improved from 19.2 (12-21) to 4 (0-21). There were three (6%) urethral perforations during surgery that were resolved by re-passing the needle. The sling was removed in three men (6%) due to erosion and in two (4%) due to infection. Seven (15%) cases of acute urinary retention resolved spontaneously, except for one that needed the sling loosening. No cases of chronic retention were reported. There was perineal discomfort and mild dysuria soon after surgery that resolved spontaneously after a few weeks. CONCLUSION This new adjustable male sling safely and effectively controls sphincter incontinence in men after prostate surgery, with an acceptably low complication rate. The early results are encouraging; the Argus is a valid alternative to the artificial urinary sphincter, the standard therapy for this condition.