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 followup. The surgical technique was one described previously, with some modifications.
RESULTSAt 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.
CONCLUSIONThis 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.
Argus has demonstrated its efficacy in long- term follow-up. The social continence rate was about 80%. The important complication was erosion or infection.
Objetivo: Comunicar los resultados a largo plazo del estudio multicéntrico fase III del tratamiento de la incontinencia post-prostatectomía (IPP) con un Sling masculino ajustable (Argus®) 1. Pacientes y métodos: 48 pacientes con IPP, 39 post radical y 9 post adenomectomía, ingresaron entre abril de 2003 y septiembre de 2004. 19 usaban 5 paños por día (3-8) pesando 83 gr. (17-198) por paño. 29 usaban clamp peniano o colector externo. El seguimiento promedio fue de 45 meses (36-54). La edad fue de 67años (52-77). Fueron evaluados con el cuestionario ICIQ-SF y la calificación de seco (sin paños), mejora (1 paño) y falla (2 o más paños en 24 hs), incluyéndose a los slings extraídos. El Argus se implantó por vía perineal, transfiriéndolo con agujas al abdomen para ser ajustado y fijado con arandelas. El ajuste se realizó por presión uretral retrograda (PUR) entre 45 y 55cm de agua. Resultados: Evaluamos 47 de 48 pacientes (1, falleció antes de 3 años) resultando secos, mejorados y fallados, 31(66%), 6 (12.8%) y 10 (21%) respectivamente. ICIQ-SF cambió de 19,5 a 6 (1-21). 5 de 31 secos, debieron reajustarse una vez. Fallaron 10 pacientes: 9 Argus retirados: 6 (12,8%) por erosión, 3 (6,2%) por infección y 1 usa 3 paños diarios. Hubieron 6 erosiones: 4 uretrales, 1 vesical y 1 parietal abdominal. El dolor persistió en 2 casos. Las complicaciones menores se resolvieron espontáneamente antes de 2 meses. Conclusiones: El Argus® demostró ser eficaz en el control de la IPP en el largo plazo en casi el 80% de los pacientes evaluados. La infección y la erosión fueron las complicaciones más importantes y los desafíos a resolver. Palabras clave: Swing masculino ajustable. Incontinencia masculina. Incontinencia pos prostatectomía. Long term results of a phase III multicentre trial of the adjustable male sling for treating urinary incontinence after prostatectomy: minimum 3 years Abstract Objective: To communicate long-term results of the multicentre phase III trial post-prostatectomy urinary incontinence (PPI) treated with an adjustable male sling 1. 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 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...
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