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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
AHS Cancer Control Alberta
Boston Scientific Corporation
Alberta Heritage Foundation for Medical Research
Information provided by (Responsible Party):
Dr. Sue Ross, University of Calgary
ClinicalTrials.gov Identifier:
NCT00234754
First received: October 5, 2005
Last updated: June 25, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Stress Urinary Incontinence
Procedure: TVT Surgery TOT Surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Surgical Management of Stress Urinary Incontinence in Women: A Randomized Clinical Trial (RCT) of TOT vs TVT

Resource links provided by NLM:


Further study details as provided by University of Calgary:

Primary Outcome Measures:
  • How effective is TOT compared to TVT in terms of objective cure at 12 months postoperatively? [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.

  • Vaginal erosion or other serious adverse outcomes of surgery over 5 years postoperatively [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • How effective is TOT compared to TVT in terms of subjective cure 12 months postoperatively? [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Incontinence-specific quality of life at 6 weeks and 12 months postoperatively? [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Satisfaction with surgery at 12 months postoperatively? [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Return to usual activities and usual sex life after surgery? [ Time Frame: 6 weeks and 1 year ] [ Designated as safety issue: No ]
  • The prevalence of voiding dysfunction at 12 months postoperatively? [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Surgical complications, both short term and long term? [ Time Frame: 6 weeks and 1 year ] [ Designated as safety issue: Yes ]
  • Utility and cost? (an economic evaluation) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Subjective effectiveness at 5 years postoperatively [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Incontinence-specific quality of life at 5 years postoperatively [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Urogenital Distress Inventory (UDI-6), Incontinence Impact Questionnaire (IIQ-7, Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)

  • Health care utilization over 5 years postoperatively [ Time Frame: 5 year ] [ Designated as safety issue: No ]
  • Cost effectiveness over 5 years postoperatively [ Time Frame: 5 year ] [ Designated as safety issue: No ]
  • Objective effectiveness at 5 years postoperatively [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Pad test leakage of <1g over period of test


Enrollment: 199
Study Start Date: September 2005
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00234754

Locations
Canada, Alberta
Calgary Health Region
Calgary, Alberta, Canada, T2N 2T9
Sponsors and Collaborators
University of Calgary
Canadian Institutes of Health Research (CIHR)
AHS Cancer Control Alberta
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
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Sue Ross, Adjunct Professor, Obstetrics and Gynecology, University of Calgary
ClinicalTrials.gov Identifier: NCT00234754     History of Changes
Other Study ID Numbers: 18421, 200400964
Study First Received: October 5, 2005
Last Updated: June 25, 2013
Health Authority: Canada: Health Canada

Keywords provided by University of Calgary:
Incontinence
Surgery
Trans-vaginal tape
Trans-obturator tape

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress
Lower Urinary Tract Symptoms
Signs and Symptoms
Urination Disorders
Urologic Diseases
Urological Manifestations

ClinicalTrials.gov processed this record on November 20, 2014