Trans-Obturator Tape Versus Trans-Vaginal Tape for Stress Urinary Incontinence in Women

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.

Study Overview

• Status: Completed
• Conditions: Stress Urinary Incontinence
• Intervention / Treatment: Procedure: TVT Surgery TOT 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?

• Study Type: Interventional
• Enrollment (Actual): 199
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 2T9
      • Calgary Health Region

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 1; Trans-vaginal tape Surgery	Procedure: TVT Surgery TOT Surgery; TVT surgery and TOT surgery
EXPERIMENTAL: 2; Trans-obturator tape surgery	Procedure: TVT Surgery TOT Surgery; TVT surgery and TOT surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
How effective is TOT compared to TVT in terms of objective cure at 12 months postoperatively?	Objective evidence of SUI will be obtained using a standardised pad test undertaken at 12 months following surgery. The pad test will be carried out using a modification of the International Continence Society (ICS) recommendations. Women will be considered 'cured' if the pad weight gain is less than 1g over the test period. This is the definition of cure used by Ward and will allow comparison with that trial.	1 year
Vaginal erosion or other serious adverse outcomes of surgery over 5 years postoperatively		5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
How effective is TOT compared to TVT in terms of subjective cure 12 months postoperatively?		1 year
Incontinence-specific quality of life at 6 weeks and 12 months postoperatively?		1 year
Satisfaction with surgery at 12 months postoperatively?		1 year
Return to usual activities and usual sex life after surgery?		6 weeks and 1 year
The prevalence of voiding dysfunction at 12 months postoperatively?		1 year
Surgical complications, both short term and long term?		6 weeks and 1 year
Utility and cost? (an economic evaluation)		1 year
Subjective effectiveness at 5 years postoperatively		5 years
Incontinence-specific quality of life at 5 years postoperatively	Urogenital Distress Inventory (UDI-6), Incontinence Impact Questionnaire (IIQ-7, Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)	5 years
Health care utilization over 5 years postoperatively		5 year
Cost effectiveness over 5 years postoperatively		5 year
Objective effectiveness at 5 years postoperatively	Pad test leakage of <1g over period of test	5 years

Collaborators and Investigators

• Sponsor: University of Calgary
• Collaborators: Canadian Institutes of Health Research (CIHR); Alberta Health services; Boston Scientific Corporation; Alberta Heritage Foundation for Medical Research
• Investigators: Principal Investigator: Sue Ross, PhD, University of Calgary; Principal Investigator: Magali Robert, MD, Univerty of Calgary, Calgary Health Region

Publications and helpful links

General Publications

• 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.
• 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.
• 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. Erratum In: BJOG. 2013 Dec;120(13):1705.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2005
• Primary Completion (ACTUAL): October 1, 2013
• Study Completion (ACTUAL): October 1, 2013

Study Registration Dates

• First Submitted: October 5, 2005
• First Submitted That Met QC Criteria: October 5, 2005
• First Posted (ESTIMATE): October 7, 2005

Study Record Updates

• Last Update Posted (ESTIMATE): August 31, 2016
• Last Update Submitted That Met QC Criteria: August 29, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Surgery; Incontinence; Trans-vaginal tape; Trans-obturator tape
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: 18421; 200400964

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Decision to share will depend on review of IPD protocol