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.
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Acknowledgements
We would like to thank Dr Malcolm Waterfield, statistician, Peninsula Medical School.
Conflicts of interest
Professor Robert Freeman: Associate editor for IUJ. Support from Peninsula Collaboration for Leadership in Applied Health Research and Care (Pen CLAHRC). Lecturer at commercially-sponsored meetings for Astellas and Pfizer. Mr David Holmes: No conflict of interest, other than capitation payment from AMS for completed data sets. Significant contribution to data acquisition, analysis and interpretation and drafting, revising and final approval of the article. Mr Timothy Hillard: No conflict of interest. Attended initial study design meeting at Southmead. Mr Mark James: No conflict of interest. Involvement was setting up study design, participated in recruitment and assessment and reviewed paper. Mr Phillip Smith: No conflict of interest. Mr Abdul Sultan: No conflict of interest. Has received speaker honoraria from Astellas.
Mr Roland Morley: No conflict of interest.
Dr Qian Yang: No conflict of interest.
Professor Paul Abrams: Consultant to: Pfizer, Astellas, Novartis, Ono. Study grant from Verathon. Lecturer for: Astellas.
This report/article presents independent research commissioned by the National Institute for Health Research (NIHR). The views expressed in this publication are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health.
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Freeman, R., Holmes, D., Hillard, T. et al. What patients think: patient-reported outcomes of retropubic versus trans-obturator mid-urethral slings for urodynamic stress incontinence—a multi-centre randomised controlled trial. Int Urogynecol J 22, 279–286 (2011). https://doi.org/10.1007/s00192-010-1343-6
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DOI: https://doi.org/10.1007/s00192-010-1343-6