Sequential treatment with ProACT™ device implantation after male sling failure for male urinary incontinence

Abstract

There is no strong evidence for second line therapy after male sling failure for post-prostatectomy urinary incontinence (PPUI). We report the outcomes after periurethral balloons implantation for persistence or recurrence of mild PPI symptoms after male sling implantation. All patients implanted of a ProACT™ device (Uromedica, Inc., MN, USA) following I-STOP transobturator male sling (TOMS) failure, in a tertiary reference center between 2009 and 2016, were included. Patients were evaluated by 24-hour pad-test before and after implantation, and after each balloon repressurizing procedure. PGI-I and Likert scale patient satisfaction were estimated during a telephone interview conducted in 2016. Objective and subjective cure of urinary incontinence were defined by a 24-hour pad-test<8g and the use of zero or one pad per day, respectively. Fourteen patients were included. Median follow-up was 34months [4-89]. Objective and subjective cure were 29% (n=4) and 57% (n=8), respectively. Median pad-test decreased from 95g [IQR: 130] to 34g [IQR: 83] (P=0.022). ProACT™ significantly decreased median pad-test by a factor 2.73 [1.19-6.29]. Eighty-eight percent patients were feeling a little better, much better or very much better and 77% were satisfied or very satisfied at the end of follow-up. Reoperation rate was 28% (n=4): 3 balloons were changed for caudally migration (n=2) or deflation (n=1) and 1 had a urinary sphincter implanted for severe UI. ProACT™ is a safe and efficient treatment that can be used in second line therapy after TOMS failure for PPUI. 4.