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(R), 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.97353353

Long term results of a phase III multicentre trial of the adjustable male sling for treating urinary incontinence after prostatectomy: minimum 3 years

Objective: To communicate long-term results of the multicentre phase III trial post-prostatectomy urinary incontinence (PPI) treated with all adjustable male sling(1). Patients and Methods: 48 PPI patients were included ill this trial from april 2003 to september 2004. 39 post radical prostatectomy and 9 post adenomectomy. 19 wore 5 pads per day (3-8) each weight 83gr (17-198). 29 wore condom catheter or penile clamp The Argus was implanted through perineal approach. Using needles. the sling was transferred to the abdominal wall where it was adjusted by washers. The adjustment was done with retrograde urethral pressure from 45 to 55 cm water. Clinical data were updated till September 2007. The mean follow-Lip was 45 months (36-54) and median age was 67 years (52-77). The evaluation was: the ICIQ-SF score and qualification as Dry: no pads, Improved: I pad and Failed: 2 or more pads in 24 hr, including those with slings removed. Results: 47 were evaluated. resulting: 31 (66%) Dry. 6 (12.8%) Improved and 10 (21%) Failed. The ICIQ-SF score changed from 19.5 to 6. Of the 31 dry pts. 5 required one adjustment. 10 pts failed. 9 after sling removal, 6 due to erosion and 3 for infection. One patient failed with the sling in place. 6 erosions were registered: 4 in the urethra. I into the bladder mid 1 through the abdominal wall. Perineal pain persisted in 2. One patient was excluded, died in September 2006. Conclusions: Argus (R) has demonstrated its efficacy in long-term follow-Lip. The social continence rate was about 80%. The important complication was erosion or infection.33330931