Overview

This trial is active, not recruiting.

Condition stress urinary incontinence
Treatment tvt surgery tot surgery
Sponsor University of Calgary
Collaborator Canadian Institutes of Health Research (CIHR)
Start date September 2005
End date October 2013
Trial size 199 participants
Trial identifier NCT00234754, 18421, 200400964

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Trans-vaginal tape Surgery
tvt surgery tot surgery
TVT surgery and TOT surgery
(Experimental)
Trans-obturator tape surgery
tvt surgery tot surgery
TVT surgery and TOT surgery

Primary Outcomes

Measure
How effective is TOT compared to TVT in terms of objective cure at 12 months postoperatively?
time frame: 1 year
Vaginal erosion or other serious adverse outcomes of surgery over 5 years postoperatively
time frame: 5 years

Secondary Outcomes

Measure
How effective is TOT compared to TVT in terms of subjective cure 12 months postoperatively?
time frame: 1 year
Incontinence-specific quality of life at 6 weeks and 12 months postoperatively?
time frame: 1 year
Satisfaction with surgery at 12 months postoperatively?
time frame: 1 year
Return to usual activities and usual sex life after surgery?
time frame: 6 weeks and 1 year
The prevalence of voiding dysfunction at 12 months postoperatively?
time frame: 1 year
Surgical complications, both short term and long term?
time frame: 6 weeks and 1 year
Utility and cost? (an economic evaluation)
time frame: 1 year
Subjective effectiveness at 5 years postoperatively
time frame: 5 years
Incontinence-specific quality of life at 5 years postoperatively
time frame: 5 years
Health care utilization over 5 years postoperatively
time frame: 5 year
Cost effectiveness over 5 years postoperatively
time frame: 5 year
Objective effectiveness at 5 years postoperatively
time frame: 5 years

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - Women with type II stress incontinence, defined as leaking with increased abdominal pressure - Are eligible for both types of surgery Exclusion Criteria: - Have vaginal prolapse requiring surgical repair - Have had previous incontinence surgery - Have overactive bladder or incontinence is caused only by bladder overflow - Intend to have further children - Have Alzheimer's or Parkinson's disease, progressive neurological disease such as multiple sclerosis, or are immunocompromised - Are unable to understand English - Will be unavailable for follow-up

Additional Information

Official title Surgical Management of Stress Urinary Incontinence in Women: A Randomized Clinical Trial (RCT) of TOT vs TVT
Principal investigator Sue Ross, PhD
Description 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?
Trial information was received from ClinicalTrials.gov and was last updated in June 2013.
Information provided to ClinicalTrials.gov by University of Calgary.