Stress Urinary Incontinence Clinical Trial
Official title:
Surgical Management of Stress Urinary Incontinence in Women: A Randomized Clinical Trial (RCT) of TOT vs TVT
Stress urinary incontinence (SUI) is a health concern for many women. The transvaginal tape (TVT) surgery has become a common procedure to address the problem. Another surgery is now available, trans-obturator tape (TOT). The investigators will compare these 2 approaches to dealing with SUI and follow the women for 1 year. Women will also be followed at 5 years after surgery.
This study is a randomized trial in which women with stress incontinence will be allocated
to receive either TOT or TVT procedures. Women who elect surgical management of their type
II stress incontinence are eligible to participate in the trial. Baseline data, including a
patient questionnaire, will be collected. Hospital outcomes, including length of stay and
surgical complications will be documented from hospital charts. All women attend a 6-week
follow-up visit as standard of care: a structured data collection form will be used by
surgeons to collect information and another patient questionnaire will be administered. At
12 months postoperatively women will attend the clinic for objective measurement of
incontinence, a full exam and to complete a questionnaire. The main outcome is effectiveness
of the procedure determined using a 1-hour pad test. Secondary research questions include:
How effective is TOT compared to TVT in terms of:
Subjective cure at 12 months postoperatively? Incontinence-specific quality of life at 6
weeks and 12 months postoperatively? Satisfaction with surgery at 12 months postoperatively?
Return to usual activities and usual sex life after surgery? The prevalence of voiding
dysfunction at 12 months postoperatively? Surgical complications, both short term and long
term? Utility and cost? (an economic evaluation) The study will be carried out according to
the ICH Good Clinical Practice Guidelines.
At 5 years postoperatively women will attend the clinic for a further follow-up. The primary
research question of the 5-year follow-up is:
Safety - What is the incidence of vaginal erosion or other serious adverse outcomes of
surgery among women who had a surgical procedure for stress urinary incontinence utilizing a
TOT device, versus a TVT device, over the 5 years following surgery?
Secondary questions are as follows:
Effectiveness - What are the objective and subjective outcomes of TOT compared with TVT at 5
years following surgery for SUI? Health economics - What are the disease-specific rates of
health service utilization related to repeat surgical intervention, as well as surgery and
other treatment related to adverse events for women who had a TOT procedure, versus those
who had a TVT procedure, over the 5 years after surgery? Using economic modelling and cost
utility analysis, is TOT cost-effective compared with TVT over the 5 years after surgery?
Other question:
Do women with tape found to be palpable in the vagina at 12 months postoperatively, go on to
develop vaginal erosion by 5 years following surgery?
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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