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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)
Information provided by (Responsible Party):
Ken Maslow, University of Manitoba Identifier:
First received: September 10, 2007
Last updated: January 8, 2016
Last verified: January 2016
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
Intervention Model: Single Group Assignment
Masking: Double Blind (Participant, 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:

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 [ Time Frame: one year ]

Enrollment: 106
Study Start Date: May 2008
Study Completion Date: October 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: TVT SECURE
Procedure: transvaginal obturator tape
Active Comparator: TVT O
Procedure: transvaginal obturator tape


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its identifier: NCT00527696

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Ken Maslow, Assistant professor, University of Manitoba Identifier: NCT00527696     History of Changes
Other Study ID Numbers: B2007:044
Study First Received: September 10, 2007
Last Updated: January 8, 2016

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders processed this record on May 24, 2017