Trial Comparing TVT SECUR System and Trans Vaginal Obturator Tape for Surgical Management of Stress Urinary Incontinence
Phase 3
Terminated
- Conditions
- Stress Urinary Incontinence
- Registration Number
- NCT00527696
- Lead Sponsor
- University of Manitoba
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 106
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Objective cure as defined by the cough test at one year from surgery one year
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie the efficacy of TVT SECUR and TVT-O in treating stress urinary incontinence?
How does the TVT SECUR system compare to TVT-O in terms of long-term success rates and complication profiles for female SUI management?
Are there specific biomarkers or patient characteristics that predict optimal outcomes with TVT SECUR versus TVT-O procedures?
What are the most common adverse events associated with TVT SECUR and TVT-O surgeries, and how are they managed in clinical practice?
How do TVT SECUR and TVT-O interventions fit into the broader landscape of mid-urethral sling therapies for stress urinary incontinence?
Trial Locations
- Locations (1)
St. Boniface Hospital
🇨🇦Winnipeg, Manitoba, Canada
St. Boniface Hospital🇨🇦Winnipeg, Manitoba, Canada