ROMANO, Salomon V. et al. Long term results of a phase III multicentre trial of the adjustable male sling for treating urinary incontinence after prostatectomy: minimum 3 years. []. , 33, 3, pp.309-314. ISSN 0210-4806.

Objective: To communicate long- term results of the multicentre phase III trial post-prostatectomy urinary incontinence (PPI) treated with an adjustable male sling¹. Patients and Methods: 48 PPI patients were included in 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 up-dated till September 2007. The mean follow-up 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: 1 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, 1 into the bladder and 1 through the abdominal wall. Perineal pain persisted in 2. One patient was excluded, died in September 2006. Conclusions: Argus^® has demonstrated its efficacy in long- term follow-up. The social continence rate was about 80%. The important complication was erosion or infection.

: Adjustable male sling; Male incontinence; Incontinence pos-prostatectomy.

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