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Trial Comparing TVT SECUR System and Trans Vaginal Obturator Tape for Surgical Management of Stress Urinary Incontinence

This study has been terminated.
(statistical Significance was reached for primary outcome)
Sponsor:
Information provided by:
University of Manitoba
ClinicalTrials.gov Identifier:
NCT00527696
First received: September 10, 2007
Last updated: April 27, 2011
Last verified: April 2011
History of Changes
  Purpose

To compare the efficacy and complications of the TVT SECUR system (TVT S) and trans-vaginal obturator tape (TVT-O) procedures for the surgical management of female stress urinary incontinence.


Condition Intervention Phase
Stress Urinary Incontinence
 Procedure: transvaginal obturator tape
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial Comparing TVT SECUR System (TVT S) and Trans Vaginal Obturator Tape (TVT-O) for Surgical Management of Stress Urinary Incontinence

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • Objective cure as defined by the cough test at one year from surgery

Enrollment: 106
Study Start Date: May 2008
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Female
Criteria

Inclusion Criteria:

  • Female patients with symptoms of stress urinary incontinence and a positive cough test who require surgical management. Cough test is positive when leakage of urine is seen from the urethra synchronously with the patient performing a cough or valsalva manuver with a comfortably full bladder in the lying or standing position.

Exclusion Criteria:

  • Women with predominantly symptoms of urge urinary incontinence
  • Presence of prolapse greater than Pelvic organ prolapse quantification (POPQ) Stage 1 or prolapse requiring surgery
  • Detrusor overactivity on cystometrogram at urodynamic testing
  • Previous surgery for incontinence
  • Intrinsic sphincter deficiency (MUCP<20 cm H2O or Q -tip <30o)
  • Voiding dysfunction with postvoid residual >100 cc
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00527696

Locations
Canada, Manitoba
St. Boniface Hospital
Winnipeg, Manitoba, Canada, R2H 2A6
Sponsors and Collaborators
University of Manitoba
Investigators
Principal Investigator: Ken D Maslow, MD St.Boniface Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00527696     History of Changes
Other Study ID Numbers: B2007:044
Study First Received: September 10, 2007
Last Updated: April 27, 2011
Health Authority: Canada: Ethics Review Committee

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

ClinicalTrials.gov processed this record on May 23, 2013