[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 an adjustable male sling.


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 83 gr (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-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.
Romano
Salomon V
SV
Urology Department, Hospital Durand, Buenos Aires, Argentina. sromano1@arnet.com.ar
Metrebian
Sergio E
SE
Vaz
Fernando
F
Muller
Valter
V
D'Ancona
Carlos A Levi
CA
de Souza
Eugenio A Costa
EA
Nakamura
Fabio
F
D000368:Aged; D004867:Equipment Design; D006801:Humans; D008297:Male; D008875:Middle Aged; D011468:Prostatectomy / Q000009:adverse effects*; D011474:Prosthesis Design; D053825:Suburethral Slings; D013997:Time Factors; D014549:Urinary Incontinence / Q000209:etiology* / Q000601:surgery*; D013521:Urologic Surgical Procedures, Male / Q000379:methods