Skip to main content
OpenTrials
Completed

NCT Number: NCT02886520

Comparative Study of PDVF and Polypropylene Transobturator Suburethral Tapes

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Urinary Stress Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urinary Incontinence, Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–90 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Hospital General de Granollers, Barcelona, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PVDF transobturator tape

Device

Other names: Dynamesh-SIS

Polypropylene transobturator tape

Device

Primary outcomes

  1. 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".

Secondary outcomes

  1. Number of participants with adverse events

    Time frame: Up to one year.

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

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Sep 1, 2016
Registry last updated
Jul 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.