Malval B, Rebibo J-D, Baron M, Nouhaud F-X, Pfister C, Cornu J-N, Grise P
Department of Urology, Charles-Nicolle University Hospital, University of Rouen, 1, rue de Germont, 76031 Rouen cedex, France.
Department of Urology, Charles-Nicolle University Hospital, University of Rouen, 1, rue de Germont, 76031 Rouen cedex, France.
Prog Urol. 2017 Dec;27(17):1084-1090. doi: 10.1016/j.purol.2017.09.010. Epub 2017 Oct 31.
To report long-term outcomes after I-Stop TOMS™ implantation for PPI.
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.
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.
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.
报告I-Stop TOMS™植入术治疗压力性尿失禁（PPI）的长期疗效。
在三个三级参考中心进行回顾性评估。纳入2007年至2012年间因轻度至中度PPI（24小时护垫试验<400g）且无盆腔放疗史而连续植入I-Stop TOMS™吊带的所有患者。术前、术后1个月和6个月以及此后每年进行评估。主要结局标准是每日使用护垫的数量。次要标准包括国际尿失禁咨询问卷（ICIQ）、SF-36问卷和并发症。
对100例患者进行了评估，中位随访时间为58个月[19 - 78个月]。末次随访时，护垫使用量显著减少，生活质量改善（P<0.0001）。术后1年时，干爽且社交场合无尿失禁（使用0或1片护垫）的患者比例分别为40%和77%，5年后分别降至15%和22%。12例患者接受了人工尿道括约肌植入术，5例接受了ProACT™球囊治疗，1例接受了再次I-Stop TOMS™植入术。末次随访时未记录到严重并发症。
I-Stop TOMS™植入术在短期治疗轻度至中度PPI方面是一种安全有效的选择。然而，长期随访后已发现存在明显的漏尿复发趋势。如果进一步研究证实，这些结果可能会对男性吊带植入术前的患者信息产生重大影响。
4级。
