Comparative Study of PDVF and Polypropylene Transobturator Suburethral Tapes

Study Overview
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Brief Summary
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This study evaluates the effectiveness and complications of polyvinylidene fluoride (PVDF) and polypropylene (PP) transobturator suburethral tapes (TOTs) in the treatment of female stress urinary incontinence. Half of participants will be operated with PVDF-TOTs, while the other half will be operated with PP ones.

Official Title
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Multicentric Randomized Clinical Trial Comparing Polyvinylidene Fluoride and Polypropylene Transobturator Suburethral Tapes in the Treatment of Female Stress Urinary Incontinence.

Conditions
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Urinary Stress Incontinence

Intervention / Treatment
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* Device: PVDF transobturator tape
* Device: Polypropylene transobturator tape


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women with stress urinary incontinence. Women with stress-predominant mixed urinary incontinence. Exclusion Criteria: Incapacity to understand the information or give their consent. Previous anti-incontinence surgery with slings. Low pressure urethra (MUCP < 20cmH2O). Neurogenic bladder.

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

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PVDF transobturator tape<br>Transobturator tension-free suburethral tape made of polyvinylidene fluoride. | Device: PVDF transobturator tape<br> <br> * Other names: Dynamesh-SIS;|
| Active Comparator: PP transobturator tape<br>Transobturator tension-free suburethral tape made of polypropylene. | Device: Polypropylene transobturator tape<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness | Percentage of patients who are regarded as cured or improved one-year after surgery with both techniques based on the following criteria: CURED: negative cough stress test and patient must be fully satisfied with the operation (no leaks, no voiding dysfunction, and no use of urinary protection); Patient Global Impresison of Improvement (PGI-I) scale must be Very much better. IMPROVED: cough stress test had to be negative and the patient moderately satisfied with the result of surgery due to an increase in urinary frequency and/or sporadic urgency episodes; PGI-I must be Much better or A little better. | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events | Comparison of the intra- and postoperative complications between both procedures. | Up to one year. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Urinary incontinence, Materials, Surgery, Transobturator tape, Polyvinylidene fluoride, Polypropylene