NCT00527696TerminatedPhase 3
Randomized Clinical Trial Comparing TVT SECUR System (TVT S) and Trans Vaginal Obturator Tape (TVT-O) for Surgical Management of Stress Urinary Incontinence
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Sponsor
- University of Manitoba
- Enrollment
- 106
- Locations
- 1
- Primary Endpoint
- Objective cure as defined by the cough test at one year from surgery
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Sex
- 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
Arms & Interventions
TVT SECURE
Active Comparator
sling
Intervention: transvaginal obturator tape (Procedure)
TVT O
Active Comparator
sling
Intervention: transvaginal obturator tape (Procedure)
Outcomes
Primary Outcomes
Objective cure as defined by the cough test at one year from surgery
Time Frame: one year
Secondary Outcomes
No secondary outcomes reported
Investigators
Ken Maslow
Assistant professor
University of Manitoba
Study Sites (1)
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