A Comparative Study Minisling Versus Transobturator (TOT)Sling
Phase 4
Completed
- Conditions
- Female Stress Urinary Incontinence
- Interventions
- Procedure: Mini-slingProcedure: Transobturator
- Registration Number
- NCT01094353
- Lead Sponsor
- Federal University of São Paulo
- Brief Summary
A study to compare efficacy in surgical treatment for SUI (Stress Urinary Incontinence), tot with minisling.
- Detailed Description
eligibility criteria was : female stress urinary incontinence
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 145
Inclusion Criteria
- clinical and urodynamic diagnosis of SUI in patients between 18 and 90 years
Exclusion Criteria
- postvoid residual urine volume more than 100 ml, coagulation disorders, current urinary tract infection, sequelae of previous radiation therapy of the pelvis, anticoagulant therapy, vulvovaginitis, and anesthesia contraindication
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mini-sling Mini-sling The minisling Ophira™ is a new intervention therapeutic option for surgical treatment in women with stress urinary incontinence. It is made of polypropylene monofilament mesh, held between two self-anchoring polypropylene columns in a fishbone design connected to two delivering needles. Transobturator Transobturator Transobturator sling Unitape™ is an outside-in approach therapeutic option for surgical treatment in women with stress urinary incontinence
- Primary Outcome Measures
Name Time Method to assess efficacy between tot with minisling in cure in women with stress urinary incontinence one year to assess efficacy and safety of minisling and transobturator sling in treatment of female stress urinary incontinence
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Federal University of São Paulo
🇧🇷São Paulo, Brazil