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 (Responsible Party):
Ken Maslow, University of Manitoba
ClinicalTrials.gov Identifier:
NCT00527696
First received: September 10, 2007
Last updated: January 8, 2016
Last verified: January 2016
  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:


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 ] [ Designated as safety issue: No ]

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
sling
Procedure: transvaginal obturator tape
Active Comparator: TVT O
sling
Procedure: transvaginal obturator tape

  Eligibility

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

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

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

ClinicalTrials.gov processed this record on July 25, 2016