Comparative Study of PDVF and Polypropylene Transobturator Suburethral Tapes

Phase 4

Completed

• Conditions: Urinary Stress Incontinence
• Interventions: Device: PVDF transobturator tape; Device: Polypropylene transobturator tape

• Registration Number: NCT02886520
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-08-27
• Study First Submitted QC: 2016-08-27
• Study First Posted: 2016-09-01
• Primary Completion: 2019-04
• Study Completion: 2019-04
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-25
• Last Update Posted: 2019-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 286

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PVDF transobturator tape	PVDF transobturator tape	Transobturator tension-free suburethral tape made of polyvinylidene fluoride.
PP transobturator tape	Polypropylene transobturator tape	Transobturator tension-free suburethral tape made of polypropylene.

Primary Outcome Measures

Name	Time	Method
Effectiveness	One year	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".

Secondary Outcome Measures

Name	Time	Method
Number of participants with adverse events	Up to one year.	Comparison of the intra- and postoperative complications between both procedures.

Trial Locations

Locations (9)

Hospital de Mataró; 🇪🇸 Barcelona, Spain

Hospital de Viladecans; 🇪🇸 Barcelona, Spain

Hospital General de Granollers; 🇪🇸 Barcelona, Spain

Hospital Universitari de Bellvitge; 🇪🇸 Barcelona, Spain

Hospital Universitari Vall d'Hebron; 🇪🇸 Barcelona, Spain

Hospital Santa Caterina; 🇪🇸 Girona, Spain

Hospital General Riotinto; 🇪🇸 Huelva, Spain

Hospital Virgen del Rocío; 🇪🇸 Sevilla, Spain

Hospital Quiron Sagrado Corazon; 🇪🇸 Sevilla, Spain