Tension-Free Vaginal Tape-O and -Secur for the Treatment of Stress Urinary Incontinence: A Thirty-Six–Month Follow-Up Single-Blind, Double-Arm, Randomized Study

Medium-term and long-term outcomes following placement of midurethral slings for stress urinary incontinence: a systematic review and metaanalysis

“…There were 11 RCTs [14][15][16][17][18][19][20][21][22][23][24] and 38 nonrandomized studies, including prospective, retrospective, and cohort studies with a total of 6,406 patients (1,200 in RCTs and 5, 206 in nonrandomized studies) aged 19 -89 years. The sample size ranged from 15 to 563 patients evaluated at the last follow-up.…”

“…7d). This result was due exclusively to pain-related complications, which were more common with TO-MUS (OR 8.75, 95 % CI 2.02 -37.90; p=0.004), based on three studies [21][22][23].…”

Tension-free vaginal tape-obturator and tension-free vaginal tape-Secur for the treatment of stress urinary incontinence: a 5-year follow-up randomized study

“…As described in the original report of this study [6], from April 2008 to April 2009, 238 patients affected by urodynamic SUI and candidate for a mid-urethral sling procedure were evaluated for inclusion in the study. A detailed description of the methods was previously published, including surgical procedures, inclusion and exclusion criteria, and pre-operative evaluation [6].…”

“…As described in the original report of this study [6], from April 2008 to April 2009, 238 patients affected by urodynamic SUI and candidate for a mid-urethral sling procedure were evaluated for inclusion in the study. A detailed description of the methods was previously published, including surgical procedures, inclusion and exclusion criteria, and pre-operative evaluation [6]. In particular, inclusion criteria were: SUI as diagnosed by clinical evaluation and urodynamics, age >30 years, and previously failed pelvic floor muscle training; while exclusion criteria were: previous surgery for SUI, isolated overactive bladder symptoms, pelvic organ prolapse !POP-Q stage II, neurologic disease, and serious contraindications to surgical procedures.…”

“…Following these contrasting results, this device was withdrawn from the market. We designed and implemented a single-blind, randomized trial comparing tension-free vaginal tape-obturator (TVT-O) with TVT-Secur (hammock approach) and demonstrated that the latter was not inferior to the established trans-obturator tape, 36 months after the original procedure [6].…”