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Experience with the artificial urinary sphincter model BR-SL-AS 904 in the treatment of urinary incontinence after radical prostatectomy: a prospective multicentric trial

Grant number: 14/16946-3
Support type:Regular Research Grants
Duration: October 01, 2014 - September 30, 2017
Field of knowledge:Health Sciences - Medicine - Surgery
Principal Investigator:João Luiz Amaro
Grantee:João Luiz Amaro
Home Institution: Faculdade de Medicina (FMB). Universidade Estadual Paulista (UNESP). Campus de Botucatu. Botucatu , SP, Brazil
Assoc. researchers: Carlos Alberto Bezerra ; Carlos Alberto Ricetto Sacomani ; Evandilson Guenes Campos de Barros ; Flavio Eduardo Trigo Rocha ; Ubirajara de Oliveira Barroso Júnior ; Wesley Justino Magnabosco

Abstract

Prostate cancer is the most common non-cutaneous solid tumor in men over 50 years of age. In cases of localized prostate cancer or locally advanced prostate cancer, radical prostatectomy (RP) can be a curative treatment with quite satisfactory oncological results. However significant rates of urinary incontinence (UI) are observed after this procedure, which may affect negatively life quality of these patients and keep them away from normal social life. Different modalities of non surgical treatment have been proposed such as perineal exercises associated with electrical stimulation(anal electrodes) and transcutaneous stimulation of the posterior tibial nerve. There is considerable disagreement concerning the use of these procedures. They are offered as first option due to the low risk of side effects but surgical treatment must be indicated when continence is not reestablished after one year of conservative management. The artificial sphincter (AS) is considered worldwide as the gold standard form of treatment in cases of post prostatectomy urinary incontinence. The existing devices in market are not economically viable due to the extremely high cost which make them unavailable to the majority of the Brazilian patients who need this modality of treatment. After a series of modifications applied to the Lima periurethral constrictor a new type of artificial sphincter ("BR-SL-AS 904") was developed. The new device whose mechanism of working is similar to the traditional sphincter already in use offers the possibility of a low cost device with similar or better efficacy that would be available as an option of treatment to a wide range of population that need this form of treatment in our country. Our objective is to test the efficacy of the use of the BR-SL-AS 904 in the control of urinary incontinence in patients that were submitted to radical prostatectomy and its possible complications. (AU)