Background: Inside out transobturator vaginal tape (TVT-O) and tension-free vaginal tape (TVT) are predominant surgical treatments for female stress urinary incontinence. This meta-analysis evaluated the complications and cure rates of TVT-O versus TVT.
Methods: A comprehensive literature search was conducted according to the Cochrane Collaboration methodology to identify randomized controlled clinical trials with no language restriction. Two authors independently assessed papers for eligibility and methodological quality. Estimates were measured by relative risk with 95% confidence intervals. Outcome measures were objective cure, subjective cure and complications. Quality rating for each outcome of the meta-analysis and recommendations were performed by the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system.
Results: Twenty randomized controlled trials met the inclusion criteria, and a pooled estimate of effectiveness and complications was made. Relative risks with 95% confidence intervals for pooled effects under the fixed effects model were: 0.20 (0.09 - 0.45), for bladder injury, 0.37 (0.16 - 0.86) for hematoma, and 2.35 (1.57 - 3.51) for postoperative pain, suggesting an 80% risk reduction of bladder injury, 63% risk reduction of hematoma, and a 1.35% risk elevation for postoperative pain with TVT-O. There was no significant difference between complications of urinary tract infection 1.14 (0.78 - 1.65), lower urinary tract symptoms 1.60 (0.67 - 3.79), recatheterization 0.93 (0.59 - 1.44), and tape erosion 0.90 (0.48 - 1.67), total objective cure rate 1.06 (0.39 - 2.84) and for the subjective cure rate 0.98 (0.93 - 1.04). The quality rating for each outcome and recommendations was high for objective cure, bladder injury, hematoma, lower urinary tract symptoms, and tape erosion and moderate for subjective cure, pain, and urinary tract infection.
Conclusions: TVT-O is associated with a reduced risk of bladder injury and hematoma and an elevated risk of postoperative pain. Other complications, including tape erosion, urinary tract infection, lower urinary tract symptoms, and recatheterization, are similar to those of TVT.