A Comparative Study Minisling Versus Transobturator (TOT)Sling

Study Overview
=================
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

Official Title
-----------------
Randomised Trial of Ophira™ Minisling System and Unitape™ for the Treatment of Stress Urinary Incontinence in Women

Conditions
-----------------
Female Stress Urinary Incontinence

Intervention / Treatment
-----------------
* Procedure: Mini-sling
* Procedure: Transobturator


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Clinical, prospective, single-center, randomized controlled trial comparing the efficacy and safety of a single-incision mini-sling and a transobturator midurethral sling for female stress urinary incontinence (SUI) treatment.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mini-sling<br>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. | Procedure: Mini-sling<br>* The minisling 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.<br>* Other names: Mini-sling Ophira™;|
| Active Comparator: Transobturator<br>Transobturator sling Unitape™ is an outside-in approach therapeutic option for surgical treatment in women with stress urinary incontinence | Procedure: Transobturator<br>* Transobturator sling Unitape™ is an outside-in approach therapeutic option for surgical treatment in women with stress urinary incontinence<br>* Other names: Transobturator Sling Unitape™;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to assess efficacy between tot with minisling in cure in women with stress urinary incontinence | to assess efficacy and safety of minisling and transobturator sling in treatment of female stress urinary incontinence | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Urodynamic Stress urinary incontinence, Minisling, Ophira™, Unitape™