Comparative Study of PDVF and Polypropylene Transobturator Suburethral Tapes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

286 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2019-04-30

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.

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Detailed Description

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Conditions

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Urinary Stress Incontinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PVDF transobturator tape

Transobturator tension-free suburethral tape made of polyvinylidene fluoride.

Group Type ACTIVE_COMPARATOR

PVDF transobturator tape

Intervention Type DEVICE

PP transobturator tape

Transobturator tension-free suburethral tape made of polypropylene.

Group Type ACTIVE_COMPARATOR

Polypropylene transobturator tape

Intervention Type DEVICE

Interventions

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PVDF transobturator tape

Intervention Type DEVICE

Polypropylene transobturator tape

Intervention Type DEVICE

Other Intervention Names

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Dynamesh-SIS

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No