Long-term outcomes of I-Stop TOMS™ male sling implantation for post-prostatectomy incontinence management.

ABSTRACT

OBJECTIVES: To report long-term outcomes after I-Stop TOMS™ implantation for PPI. PATIENTS AND METHODS: A retrospective evaluation was conducted in three tertiary reference centers. All consecutive patients implanted with an I-Stop TOMS™ sling between 2007 and 2012 for mild to moderate PPI (24-hour Pad test<400g) without history of pelvic radiation therapy were included. Evaluation had been conducted preoperatively, at one and six months postoperative and yearly thereafter. The main outcome criterion was the number of pads per day. Secondary criteria were International Consultation on Incontinence Questionnaire (ICIQ), SF-36 questionnaire, and complications. RESULTS: A hundred patients were evaluated with a median follow-up of 58months [19-78]. Pad use was significantly reduced and quality of life improved at last follow-up (P<0.0001). The percentage of patients dry and socially continent (0 or 1 pad) were 40% and 77% at 1 year, then dropped to 15% and 22%, respectively after 5years. Twelve patients were treated by artificial urinary sphincter implantation, five by ProACT™ balloons and one by a re-do I-Stop TOMS™. No severe complications were recorded at last follow-up. CONCLUSIONS: I-Stop TOMS™ implantation is a safe and effective option in the short-term for mild to moderate PPI management. However, a significant trend to recurrence of leakage has been established after long-term follow-up. If confirmed by further studies, these results may substantially impact patient information before male sling implantation. LEVEL OF EVIDENCE 4.