Trans-Obturator Tape vs. Trans-Vaginal Tape for Stress Urinary Incontinence in Women - Full Text View

Sponsors and Collaborators:	University of Calgary Calgary Health Region Boston Scientific Corporation
Information provided by:	University of Calgary
ClinicalTrials.gov Identifier:	NCT00234754

Purpose

Stress urinary incontinence is a health concern for many women. The transvaginal tape surgery has become a common procedure to address the problem. Another surgery is now available, tran-obturator tape. We will compare these 2 approaches to dealing with SUI and follow the women for 1 year.

Condition	Intervention
Stress Urinary Incontinence	Procedure: TVT Surgery TOT Surgery

MedlinePlus related topics: Pelvic Support Problems Urinary Incontinence

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	Surgical Management of Stress Urinary Incontinence in Women: An RCT of TOT vs TVT

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 ]

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 ]

Enrollment:	201
Study Start Date:	September 2005
Estimated Study Completion Date:	August 2008
Estimated Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Trans-vaginal tape Surgery	Procedure: TVT Surgery TOT Surgery TVT surgery and TOT surgery
2: Experimental 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 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.

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

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

Calgary Health Region

Boston Scientific Corporation

Investigators

Study Director:	Sue J Ross, PhD	University of Calgary
Principal Investigator:	Magali Robert, MD	Univerty of Calgary, Calgary Health Region

More Information

Responsible Party:	University of Calgary ( Dr. Magali Robert )
Study ID Numbers:	18421, 200400964
Study First Received:	October 5, 2005
Last Updated:	June 5, 2008
ClinicalTrials.gov Identifier:	NCT00234754
Health Authority:	Canada: Health Canada

Keywords provided by University of Calgary:

Incontinence
Surgery
Trans-vaginal tape
Trans-obturator tape

Study placed in the following topic categories:

Signs and Symptoms
Urinary Incontinence, Stress
Urologic Diseases

Urination Disorders
Stress
Urinary Incontinence

Additional relevant MeSH terms:

Urological Manifestations
Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009