Comparative Study of PDVF and Polypropylene Transobturator Suburethral Tapes

July 25, 2019 updated by: Hospital Universitari Vall d'Hebron Research Institute

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

286

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain
        • Hospital Universitari Vall d'Hebron
      • Barcelona, Spain
        • Hospital Universitari de Bellvitge
      • Barcelona, Spain
        • Hospital de Mataró
      • Barcelona, Spain
        • Hospital de Viladecans
      • Barcelona, Spain
        • Hospital General de Granollers
      • Girona, Spain
        • Hospital Santa Caterina
      • Huelva, Spain
        • Hospital General Riotinto
      • Sevilla, Spain
        • Hospital Virgen del Rocío
      • Sevilla, Spain
        • Hospital Quiron Sagrado Corazon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: PVDF transobturator tape
Transobturator tension-free suburethral tape made of polyvinylidene fluoride.
Device: PVDF transobturator tape
Other Names:
  • Dynamesh-SIS
Active Comparator: PP transobturator tape
Transobturator tension-free suburethral tape made of polypropylene.
Device: Polypropylene transobturator tape

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness
Time Frame: 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".
One year

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in subjective questionnaires of incontinence severity
Time Frame: One year

Change in the punctuation of the following questionnaires comparing before surgery and one year after operation:

  • International consultation on Incontinence Urinary Questionnaire-Short Form (ICIQ-SF).
  • Sandvik severity index.
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Collaborators

Hospital Universitari de Bellvitge
Hospitales Universitarios Virgen del Rocío
Hospital de Granollers
Hospital de Mataró
Hospital Quiron Sagrado Corazon
Hospital Riotinto
Hospital de Viladecans
Hospital Santa Caterina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2016

Primary Completion (Actual)

April 1, 2019

Study Completion (Actual)

April 1, 2019

Study Registration Dates

First Submitted

August 27, 2016

First Submitted That Met QC Criteria

August 27, 2016

First Posted (Estimate)

September 1, 2016

Study Record Updates

Last Update Posted (Actual)

July 26, 2019

Last Update Submitted That Met QC Criteria

July 25, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR(AMI)241-2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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