Comparative Study of PDVF and Polypropylene Transobturator Suburethral Tapes

NCT02886520 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 286

Last updated 2019-07-26

No results posted yet for this study

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.

Conditions

  • Urinary Stress Incontinence

Interventions

DEVICE

PVDF transobturator tape

DEVICE

Polypropylene transobturator tape

Sponsors & Collaborators

  • Hospital de Granollers

    collaborator OTHER
  • Hospital Quiron Sagrado Corazon

    collaborator OTHER
  • Hospital de Mataró

    collaborator OTHER
  • Hospital Riotinto

    collaborator UNKNOWN
  • Hospitales Universitarios Virgen del Rocío

    collaborator OTHER
  • Hospital Universitari de Bellvitge

    collaborator OTHER
  • Hospital de Viladecans

    collaborator OTHER
  • Hospital Santa Caterina

    collaborator UNKNOWN
  • Hospital Universitari Vall d'Hebron Research Institute

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2019-04-30
Completion
2019-04-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02886520 on ClinicalTrials.gov