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Comparative Study of PDVF and Polypropylene Transobturator Suburethral Tapes

Sponsor
Hospital Universitari Vall d'Hebron Research Institute (Other)
Overall Status
Completed
CT.gov ID
NCT02886520
Collaborator
Hospital de Granollers (Other), Hospital Quiron Sagrado Corazon (Other), Hospital de Mataró (Other), Hospital Riotinto (Other), Hospitales Universitarios Virgen del Rocío (Other), Hospital Universitari de Bellvitge (Other), Hospital de Viladecans (Other), Hospital Santa Caterina (Other)
286
Enrollment
9
Locations
2
Arms
36
Actual Duration (Months)
31.8
Patients Per Site
0.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: PVDF transobturator tape
  • Device: Polypropylene transobturator tape
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
286 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Multicentric Randomized Clinical Trial Comparing Polyvinylidene Fluoride and Polypropylene Transobturator Suburethral Tapes in the Treatment of Female Stress Urinary Incontinence.
Actual Study Start Date :
Apr 1, 2016
Actual Primary Completion Date :
Apr 1, 2019
Actual Study Completion Date :
Apr 1, 2019

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Number of participants with adverse events [Up to one year.]

      Comparison of the intra- and postoperative complications between both procedures.

    Other Outcome Measures

    1. Change in subjective questionnaires of incontinence severity [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital de Mataró Barcelona Spain
    2 Hospital de Viladecans Barcelona Spain
    3 Hospital General de Granollers Barcelona Spain
    4 Hospital Universitari de Bellvitge Barcelona Spain
    5 Hospital Universitari Vall d'Hebron Barcelona Spain
    6 Hospital Santa Caterina Girona Spain
    7 Hospital General Riotinto Huelva Spain
    8 Hospital Quiron Sagrado Corazon Sevilla Spain
    9 Hospital Virgen del Rocío Sevilla Spain

    Sponsors and Collaborators

    • Hospital Universitari Vall d'Hebron Research Institute
    • Hospital de Granollers
    • Hospital Quiron Sagrado Corazon
    • Hospital de Mataró
    • Hospital Riotinto
    • Hospitales Universitarios Virgen del Rocío
    • Hospital Universitari de Bellvitge
    • Hospital de Viladecans
    • Hospital Santa Caterina

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hospital Universitari Vall d'Hebron Research Institute
    ClinicalTrials.gov Identifier:
    NCT02886520
    Other Study ID Numbers:
    • PR(AMI)241-2015
    First Posted:
    Sep 1, 2016
    Last Update Posted:
    Jul 26, 2019
    Last Verified:
    Jul 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Hospital Universitari Vall d'Hebron Research Institute
    Urinary incontinence
    Materials
    Surgery
    Transobturator tape
    Polyvinylidene fluoride
    Polypropylene
    Additional relevant MeSH terms:
    Urinary Incontinence, Stress

    Study Results

    No Results Posted as of Jul 26, 2019