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

BMC Women's Health

Study Protocol

Misha Eliasziw¹  Philip Jacobs²  Sue Ross³  Magali Robert³  Doug Lier⁴ 

[1] Department of Community Health Sciences, University of Calgary, T2N 4Z6, Calgary, Canada;Department of Medicine, University of Alberta, T6G 2R3, Edmonton, Canada;Department of Obstetrics and Gynaecology, University of Calgary, T2N 2T9, Calgary, Canada;Institute of Health Economics, T6G 2R3, Edmonton, Canada;

关键词: Urinary incontinence;    stress/surgery;    suburethral slings;    female;    treatment outcome;    cost-effectiveness;    5 year follow-u;   

DOI  :  10.1186/1472-6874-11-34

 received in 2011-05-10, accepted in 2011-07-22,  发布年份 2011

来源: Springer

【 摘 要 】

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.

【 授权许可】

CC BY   
© Ross et al; licensee BioMed Central Ltd. 2011