Surgical management of stress urinary incontinence in women: safety, effectiveness and cost-utility of trans-obturator tape (TOT) versus tension-free vaginal tape (TVT) five years after a randomized surgical trial

Abstract

BackgroundWe recently completed a randomized clinical trial of two minimally invasive surgical procedures for stress urinary incontinence, the retropubic tension-free vaginal tape (TVT) versus the trans-obturator tape (TOT) procedure. At one year postoperatively, we were concerned to find that a significant number of women had tape that was palpable when a vaginal examination was undertaken. Because the risk factors for adverse outcomes of tape surgery are not clearly understood, we are unable to say whether palpable tapes will lead to vaginal erosions or whether they merge into vaginal tissue. We do not know whether patients go on to have further adverse consequences of surgery, leading to additional cost to patients and healthcare system. Our current study is a 5 year follow-up of the women who took part in our original trial.Methods/DesignAll 199 women who participated in our original trial will be contacted and invited to take part in the follow-up study. Consenting women will attend a clinic visit where they will have a physical examination to identify vaginal erosion or other serious adverse outcomes of surgery, undertake a standardized pad test for urinary incontinence, and complete several health-related quality of life questionnaires (15D, UDI-6, IIQ-7). Analyses will compare the outcomes for women in the TOT versus TVT groups. The cost-effectiveness of TOT versus TVT over the 5 years after surgery, will be assessed with the use of disease-specific health service administrative data and an objective health outcome measure. A cost-utility analysis may also be undertaken, based on economic modeling, data from the clinical trial and inputs obtained from published literature.DiscussionThis study is needed now, because TOT and TVT are among the most frequently conducted surgical procedures for stress urinary incontinence in Canada. Because stress urinary incontinence is so common, the impact of selecting an approach that causes more adverse events, or is less effective, will have a significant impact on individual quality of life, and societal and health care costs.Trial registrationClinicalTrials.gov NCT00234754. Registered October 2005.

Will future doctors know enough about stress urinary incontinence to provide proper preventive measures and treatment?

“…Operations with TVT tapes are widely described in the literature because they are simple to perform. They have a high clinical effectiveness and a low percentage of intraoperative and post-operative complications [26,27].…”

Evaluation and surgery for stress urinary incontinence: A FIGO working group report

“…34 Both the TVT and TOT procedures have demonstrated similar efficacy treating SUI. [35][36][37][38][39][40][41][42][43][44][45] More recently, a systematic review from SGS and a Cochrane review assessing the use of MUS to treat SUI have both confirmed the efficacy of TVT and TOT procedures. 34,46 A still less invasive type of MUS is the mini-sling, single incision sling, or single incision mini-sling (SIMS).…”

Recent status of the treatment of stress urinary incontinence

“…Figure shows the risk of complications associated with TOT and TVT approaches from a meta‐analysis . In a recent RCT of TVT versus TOT, the authors noted that although there was no significant difference between the cure rates, a palpable tape was noted more frequently in the TOT group (RR 0.22 95% CI 0.13–0.3; P < 0.001) . Ross et al .…”

“…40 In a recent RCT of TVT versus TOT, the authors noted that although there was no significant difference between the cure rates, a palpable tape was noted more frequently in the TOT group (RR 0.22 95% CI 0.13-0.3; P < 0.001). 45 Ross et al evaluated the economic benefit of TOT against TVT in a RCT. 46 TOT had a non-significant cost-savings benefit in comparison with TVT based on a study of a total of 194 women followed to 1 year post-surgery.…”