Single Incision Device (TVT Secur) Versus Retropubic Tension-free Vaginal Tape Device (TVT) for the Management of Stress Urinary Incontinence in Women: A Randomized Clinical Trial

The objective of this Canadian multi-centre pragmatic randomized controlled trial was to compare the effectiveness of the new single-incision device, Gynecare TVT Secur, to the established predecate retropubic TVT device, in terms of objective cure of stress urinary incontinence (SUI) at 12 months postoperatively. Other outcomes included: complications, symptoms, and incontinence-related quality of life.

本项加拿大多中心实用性随机对照试验的研究目的，是对比新型单切口装置Gynecare TVT Secur与已获批的经耻骨后TVT装置，在术后12个月时对压力性尿失禁（stress urinary incontinence, SUI）的客观治愈效果。其余研究结局指标包括并发症、临床症状以及尿失禁相关生活质量。