Resultados a largo plazo del estudio multicéntrico fase III del tratamiento de la incontinencia de orina post prostatectomía con un sling masculino ajustable: seguimiento mínimo 3 años
Long term results of a phase III multicentre trial of the adjustable male sling for treating urinary incontinence after prostatectomy: minimum 3 years
V. Salomon Romano1,
, E. Sergio Metrebian**, Vaz Fernando***, Muller Valter***, A. Carlos Levi D’Ancona****, A. Eugenio Costa de Souza*****, Fabio Nakamura******
* Urology Department, Hospital Durand. Buenos Aires, Argentina
** Urology Department, Hospital Privado, Cordoba, Argentina
*** Urology Department, Hospital Dos Servidores Do Estado, Rio De Janeiro,Brasil
**** Urology Department, Universidad De Unicamp, Campinas, Brasil
***** Urology Department, Fundaçao Felice Rosso, Belo Horizonte Brasil
****** Centro Medico Ultralitho, Florianopolis, Brazil
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Romano Departamento de Urología. Hospital Durand. Díaz Vélez 5044. Parque Centenario, Buenos Aires. Argentina Tel.: 49825555" ] ] ] ] "titulosAlternativos" => array:1 [ "en" => array:1 [ "titulo" => "Long term results of a phase III multicentre trial of the adjustable male sling for treating urinary incontinence after prostatectomy: minimum 3 years" ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "fechaRecibido" => "2008-07-01" "fechaAceptado" => "2008-10-01" "PalabrasClave" => array:2 [ "es" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Palabras clave" "identificador" => "xpalclavsec88885" "palabras" => array:3 [ 0 => "Swing masculino ajustable" 1 => "Incontinencia masculina" 2 => "Incontinencia pos prostatectomía" ] ] ] "en" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Key words" "identificador" => "xpalclavsec88886" "palabras" => array:3 [ 0 => "Adjustable male sling" 1 => "Male incontinence" 2 => "Incontinence pos-prostatectomy" ] ] ] ] "tieneResumen" => true "resumen" => array:2 [ "es" => array:2 [ "titulo" => "Resumen" "resumen" => "<span class="elsevierStyleSectionTitle">Objetivo</span><p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">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.</p> <span class="elsevierStyleSectionTitle">Pacientes y método</span><p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">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.</p> <span class="elsevierStyleSectionTitle">Resultados</span><p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">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.</p> <span class="elsevierStyleSectionTitle">Conclusiones</span><p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">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.</p>" ] "en" => array:1 [ "resumen" => "<span class="elsevierStyleSectionTitle">Objective</span><p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">To communicate long- term results of the multicentre phase III trial post-prostatectomy urinary incontinence (PPI) treated with an adjustable male sling1.</p> <span class="elsevierStyleSectionTitle">Patients and Methods</span><p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">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.</p> <span class="elsevierStyleSectionTitle">Results</span><p id="spar0035" class="elsevierStyleSimplePara elsevierViewall">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.</p> <span class="elsevierStyleSectionTitle">Conclusions</span><p id="spar0040" class="elsevierStyleSimplePara elsevierViewall">Argus® has demonstrated its efficacy in long- term follow-up. The social continence rate was about 80%. The important complication was erosion or infection.</p>" ] ] "bibliografia" => array:2 [ "titulo" => "Referencias" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0005" "bibliografiaReferencia" => array:15 [ 0 => array:3 [ "identificador" => "bib0005" "etiqueta" => "1." "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "An adjustable male sling for treating urinary incontinence after prostatectomy - a phase iii multi-centre trial" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:7 [ 0 => "S.V. Romano" 1 => "S.E. Metrebian" 2 => "F. Vaz" 3 => "V. Muller" 4 => "C.A. Levi D’Ancona" 5 => "E.A. Costa De Souza" 6 => "F. 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| año/Mes | Html | Total | |
|---|---|---|---|
| 2024 Noviembre | 0 | 1 | 1 |
| 2024 Octubre | 0 | 7 | 7 |
| 2024 Septiembre | 0 | 6 | 6 |
| 2024 Agosto | 0 | 12 | 12 |
| 2024 Julio | 0 | 9 | 9 |
| 2024 Junio | 0 | 12 | 12 |
| 2024 Mayo | 0 | 10 | 10 |
| 2024 Abril | 0 | 15 | 15 |
| 2024 Marzo | 0 | 22 | 22 |
| 2024 Febrero | 0 | 14 | 14 |
| 2024 Enero | 0 | 19 | 19 |
| 2023 Diciembre | 0 | 14 | 14 |
| 2023 Noviembre | 0 | 45 | 45 |
| 2023 Octubre | 0 | 35 | 35 |
| 2023 Septiembre | 0 | 13 | 13 |
| 2023 Agosto | 0 | 11 | 11 |
| 2023 Julio | 0 | 36 | 36 |
| 2023 Junio | 0 | 10 | 10 |
| 2023 Mayo | 0 | 2 | 2 |
| 2023 Abril | 0 | 5 | 5 |
| 2023 Marzo | 0 | 8 | 8 |
| 2023 Febrero | 0 | 11 | 11 |
| 2023 Enero | 0 | 17 | 17 |
| 2022 Diciembre | 0 | 4 | 4 |
| 2022 Noviembre | 0 | 7 | 7 |
| 2022 Octubre | 0 | 5 | 5 |
| 2022 Septiembre | 0 | 12 | 12 |
| 2022 Agosto | 0 | 11 | 11 |
| 2022 Julio | 0 | 4 | 4 |
| 2022 Junio | 0 | 16 | 16 |
| 2022 Mayo | 0 | 2 | 2 |
| 2022 Abril | 0 | 9 | 9 |
| 2022 Marzo | 0 | 6 | 6 |
| 2022 Febrero | 0 | 2 | 2 |
| 2022 Enero | 0 | 4 | 4 |
| 2021 Diciembre | 0 | 1 | 1 |
| 2021 Noviembre | 0 | 3 | 3 |
| 2021 Octubre | 0 | 7 | 7 |
| 2021 Septiembre | 0 | 2 | 2 |
| 2021 Agosto | 0 | 3 | 3 |
| 2021 Julio | 0 | 2 | 2 |
| 2021 Junio | 0 | 3 | 3 |
| 2021 Mayo | 0 | 6 | 6 |
| 2021 Abril | 0 | 1 | 1 |
| 2021 Marzo | 0 | 7 | 7 |
| 2021 Febrero | 0 | 1 | 1 |
| 2021 Enero | 0 | 4 | 4 |
| 2020 Diciembre | 2 | 3 | 5 |
| 2020 Noviembre | 0 | 4 | 4 |
| 2020 Octubre | 0 | 2 | 2 |
| 2020 Septiembre | 0 | 6 | 6 |
| 2020 Agosto | 0 | 2 | 2 |
| 2020 Julio | 0 | 1 | 1 |
| 2020 Junio | 0 | 2 | 2 |
| 2020 Mayo | 0 | 5 | 5 |
| 2020 Abril | 0 | 6 | 6 |
| 2020 Marzo | 0 | 5 | 5 |
| 2020 Febrero | 0 | 5 | 5 |
| 2020 Enero | 0 | 19 | 19 |
| 2019 Diciembre | 0 | 12 | 12 |
| 2019 Noviembre | 0 | 2 | 2 |
| 2019 Octubre | 0 | 10 | 10 |
| 2019 Septiembre | 0 | 12 | 12 |
| 2019 Agosto | 0 | 6 | 6 |
| 2019 Julio | 0 | 25 | 25 |
| 2019 Junio | 0 | 37 | 37 |
| 2019 Mayo | 0 | 66 | 66 |
| 2019 Abril | 0 | 20 | 20 |
| 2019 Marzo | 0 | 2 | 2 |
| 2019 Febrero | 0 | 19 | 19 |
| 2019 Enero | 0 | 4 | 4 |
| 2018 Diciembre | 0 | 11 | 11 |
| 2018 Noviembre | 0 | 17 | 17 |
| 2018 Octubre | 0 | 20 | 20 |
| 2018 Septiembre | 0 | 1 | 1 |
| 2018 Julio | 0 | 1 | 1 |
| 2018 Junio | 0 | 1 | 1 |
| 2018 Febrero | 2 | 7 | 9 |
| 2017 Diciembre | 3 | 2 | 5 |
| 2017 Noviembre | 1 | 10 | 11 |
| 2017 Octubre | 7 | 7 | 14 |
| 2017 Septiembre | 5 | 12 | 17 |
| 2017 Agosto | 7 | 13 | 20 |
| 2017 Julio | 5 | 13 | 18 |
| 2017 Junio | 7 | 13 | 20 |
| 2017 Mayo | 6 | 17 | 23 |
| 2017 Abril | 16 | 14 | 30 |
| 2017 Marzo | 24 | 31 | 55 |
| 2017 Febrero | 11 | 8 | 19 |
| 2017 Enero | 12 | 6 | 18 |
| 2016 Diciembre | 35 | 8 | 43 |
| 2016 Noviembre | 37 | 16 | 53 |
| 2016 Octubre | 35 | 6 | 41 |
| 2016 Septiembre | 10 | 3 | 13 |
| 2016 Agosto | 8 | 3 | 11 |
| 2016 Julio | 15 | 1 | 16 |
| 2016 Junio | 7 | 24 | 31 |
| 2016 Mayo | 18 | 25 | 43 |
| 2016 Abril | 11 | 16 | 27 |
| 2016 Marzo | 10 | 30 | 40 |
| 2016 Febrero | 9 | 32 | 41 |
| 2016 Enero | 9 | 30 | 39 |
| 2015 Diciembre | 15 | 21 | 36 |
| 2015 Noviembre | 17 | 18 | 35 |
| 2015 Octubre | 19 | 23 | 42 |
| 2015 Septiembre | 9 | 47 | 56 |
| 2015 Agosto | 4 | 13 | 17 |
| 2015 Julio | 10 | 6 | 16 |
| 2015 Junio | 1 | 3 | 4 |
| 2015 Mayo | 15 | 7 | 22 |
| 2015 Abril | 5 | 14 | 19 |
| 2015 Marzo | 5 | 8 | 13 |
| 2015 Febrero | 4 | 4 | 8 |
| 2015 Enero | 13 | 6 | 19 |
| 2014 Diciembre | 10 | 8 | 18 |
| 2014 Noviembre | 9 | 3 | 12 |
| 2014 Octubre | 10 | 8 | 18 |
| 2014 Septiembre | 6 | 4 | 10 |
| 2014 Agosto | 7 | 3 | 10 |
| 2014 Julio | 15 | 1 | 16 |
| 2014 Junio | 4 | 4 | 8 |
| 2014 Mayo | 5 | 1 | 6 |
| 2014 Abril | 2 | 5 | 7 |
| 2014 Marzo | 6 | 1 | 7 |
| 2014 Febrero | 2 | 4 | 6 |
| 2014 Enero | 6 | 2 | 8 |
| 2013 Diciembre | 15 | 1 | 16 |
| 2013 Noviembre | 5 | 1 | 6 |
| 2013 Octubre | 7 | 10 | 17 |
| 2013 Septiembre | 4 | 8 | 12 |
| 2013 Agosto | 2 | 4 | 6 |
| 2013 Julio | 2 | 1 | 3 |
| 2009 Marzo | 341 | 0 | 341 |
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