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Transvaginal Tape (TVT) Secur Versus TVT Randomised Controlled Trial (RCT)

NCT00685217 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2016-08-31

No results posted yet for this study

Summary

This randomized multi-centre trial will recruit women with stress urinary incontinence who need surgical treatment for their condition. 300 women will be allocated either to receive a TVT Secur or a standard TVT surgical procedure. The main outcome is effectiveness of the procedure, determined using a 1-hour pad test (which tests for urine leakage) 12 months after surgery. The study will be carried out in 4 to 6 centers and will involve urogynaecologists, urologists and general obstetrician-gynaecologists: all clinicians will have received adequate training.

Conditions

  • Urinary Incontinence, Stress

Interventions

PROCEDURE

TVT Secur (Gynecare)

Sling device for stress urinary incontinence

PROCEDURE

TVT (Gynecare)

Sling procedure for stress urinary incontinence

Sponsors & Collaborators

  • University of Alberta

    collaborator OTHER

  • Johnson & Johnson Medical Companies

    collaborator INDUSTRY

  • University of Calgary

    lead OTHER

Principal Investigators

  • Sue Ross, PhD · University of Calgary

  • Magali Robert, MD · University of Calgary

  • Jane Schulz, MD · University of Alberta

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2011-03-31
Completion
2012-04-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00685217 on ClinicalTrials.gov