Clinical trial NCT00234754: Trans-Obturator Tape Versus Trans-Vaginal Tape for Stress Urinary Incontinence in Women
Official title: Surgical Management of Stress Urinary Incontinence in Women: A Randomized Clinical Trial (RCT) of TOT vs TVT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Urinary Incontinence
Keywords: Incontinence
Surgery
Trans-vaginal tape
Trans-obturator tape
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Alberta Health services
name: Boston Scientific Corporation
name: Alberta Heritage Foundation for Medical Research
First posted: 2005-10-07
Enrollment: 199
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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?

Eligibility criteria: 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

Primary outcomes:
measure: How effective is TOT compared to TVT in terms of objective cure at 12 months postoperatively?
timeFrame: 1 year
measure: Vaginal erosion or other serious adverse outcomes of surgery over 5 years postoperatively
timeFrame: 5 years
Secondary outcomes:
measure: How effective is TOT compared to TVT in terms of subjective cure 12 months postoperatively?
timeFrame: 1 year
measure: Incontinence-specific quality of life at 6 weeks and 12 months postoperatively?
timeFrame: 1 year
measure: Satisfaction with surgery at 12 months postoperatively?
timeFrame: 1 year
measure: Return to usual activities and usual sex life after surgery?
timeFrame: 6 weeks and 1 year
measure: The prevalence of voiding dysfunction at 12 months postoperatively?
timeFrame: 1 year
measure: Surgical complications, both short term and long term?
timeFrame: 6 weeks and 1 year
measure: Utility and cost? (an economic evaluation)
timeFrame: 1 year
measure: Subjective effectiveness at 5 years postoperatively
timeFrame: 5 years
measure: Incontinence-specific quality of life at 5 years postoperatively
timeFrame: 5 years
measure: Health care utilization over 5 years postoperatively
timeFrame: 5 year
measure: Cost effectiveness over 5 years postoperatively
timeFrame: 5 year
measure: Objective effectiveness at 5 years postoperatively
timeFrame: 5 years
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Calgary Health Region
state: Alberta
Study officials:
affiliation: University of Calgary
name: Sue Ross, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Univerty of Calgary, Calgary Health Region
name: Magali Robert, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ross S, Robert M, Lier D, Eliasziw M, Jacobs P. 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 Womens Health. 2011 Jul 22;11:34. doi: 10.1186/1472-6874-11-34.
citation: Ross S, Robert M, Swaby C, Dederer L, Lier D, Tang S, Brasher P, Birch C, Cenaiko D, Mainprize T, Murphy M, Carlson K, Baverstock R, Jacobs P, Williamson T. Transobturator tape compared with tension-free vaginal tape for stress incontinence: a randomized controlled trial. Obstet Gynecol. 2009 Dec;114(6):1287-1294. doi: 10.1097/AOG.0b013e3181c2a151.
citation: Lier D, Ross S, Tang S, Robert M, Jacobs P; Calgary Women's Pelvic Health Research Group. Trans-obturator tape compared with tension-free vaginal tape in the surgical treatment of stress urinary incontinence: a cost utility analysis. BJOG. 2011 Apr;118(5):550-6. doi: 10.1111/j.1471-0528.2010.02845.x. Epub 2011 Feb 4.
citation: Ross S, Tang S, Eliasziw M, Lier D, Girard I, Brennand E, Dederer L, Jacobs P, Robert M. Transobturator tape versus retropubic tension-free vaginal tape for stress urinary incontinence: 5-year safety and effectiveness outcomes following a randomised trial. Int Urogynecol J. 2016 Jun;27(6):879-86. doi: 10.1007/s00192-015-2902-7. Epub 2015 Dec 15.
citation: Lier D, Robert M, Tang S, Ross S. Surgical treatment of stress urinary incontinence-trans-obturator tape compared with tension-free vaginal tape-5-year follow up: an economic evaluation. BJOG. 2017 Aug;124(9):1431-1439. doi: 10.1111/1471-0528.14227. Epub 2016 Aug 10.