What patients think: patient-reported outcomes of retropubic versus trans-obturator mid-urethral slings for urodynamic stress incontinence--a multi-centre randomised controlled trial

Abstract

Introduction and hypothesis: The purpose of this study is to determine if the trans-obturator tape (TOT; Monarc, American Medical Systems (AMS)), which has been claimed to have similar or improved outcomes to retropubic mid-urethral slings, was equivalent (but not inferior) to the trans-vaginal tape (TVT; Gynecare) by using patient-reported outcomes for the treatment of urodynamic stress incontinence.

Methods: The primary outcome was the percentage cured of the symptom of stress urinary incontinence at 12 months on the International Consultation on Incontinence Modular Questionnaire-Female Lower Urinary Tract Symptoms question, 'does urine leak when you are physically active, exert yourself, cough or sneeze?'. Secondary outcomes included: quality of life, pain scores, global impression of improvement, patient satisfaction and complications. Objective assessments included cough stress test, urinary diary and pad test.

Results: At 12 months, 55 (65.5%) of the TVT group and 59 (63.4%) of the TOT group reported no stress incontinence. TOT was not inferior to TVT. There was less blood loss and pain with TOT than with TVT. There were improvements in quality of life, sexual function and patient satisfaction within groups but not between groups.

Conclusion: Patient-reported outcomes have shown that TOT is not inferior to TVT, but both produce lower success rates than studies using objective measures.