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Comparative Study of PDVF and Polypropylene Transobturator Suburethral Tapes

Primary Purpose

Urinary Stress Incontinence

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
PVDF transobturator tape
Polypropylene transobturator tape
Sponsored by
Hospital Universitari Vall d'Hebron Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Stress Incontinence focused on measuring Urinary incontinence, Materials, Surgery, Transobturator tape, Polyvinylidene fluoride, Polypropylene

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

PVDF transobturator tape

PP transobturator tape

Arm Description

Transobturator tension-free suburethral tape made of polyvinylidene fluoride.

Transobturator tension-free suburethral tape made of polypropylene.

Outcomes

Primary Outcome Measures

Effectiveness
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

Number of participants with adverse events
Comparison of the intra- and postoperative complications between both procedures.

Full Information

First Posted
August 27, 2016
Last Updated
July 25, 2019
Sponsor
Hospital Universitari Vall d'Hebron Research Institute
Collaborators
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
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1. Study Identification

Unique Protocol Identification Number
NCT02886520
Brief Title
Comparative Study of PDVF and Polypropylene Transobturator Suburethral Tapes
Official Title
Multicentric Randomized Clinical Trial Comparing Polyvinylidene Fluoride and Polypropylene Transobturator Suburethral Tapes in the Treatment of Female Stress Urinary Incontinence.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
April 2016 (Actual)
Primary Completion Date
April 2019 (Actual)
Study Completion Date
April 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Universitari Vall d'Hebron Research Institute
Collaborators
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

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Stress Incontinence
Keywords
Urinary incontinence, Materials, Surgery, Transobturator tape, Polyvinylidene fluoride, Polypropylene

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
286 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PVDF transobturator tape
Arm Type
Active Comparator
Arm Description
Transobturator tension-free suburethral tape made of polyvinylidene fluoride.
Arm Title
PP transobturator tape
Arm Type
Active Comparator
Arm Description
Transobturator tension-free suburethral tape made of polypropylene.
Intervention Type
Device
Intervention Name(s)
PVDF transobturator tape
Other Intervention Name(s)
Dynamesh-SIS
Intervention Type
Device
Intervention Name(s)
Polypropylene transobturator tape
Primary Outcome Measure Information:
Title
Effectiveness
Description
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".
Time Frame
One year
Secondary Outcome Measure Information:
Title
Number of participants with adverse events
Description
Comparison of the intra- and postoperative complications between both procedures.
Time Frame
Up to one year.
Other Pre-specified Outcome Measures:
Title
Change in subjective questionnaires of incontinence severity
Description
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.
Time Frame
One year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Hospital de Mataró
City
Barcelona
Country
Spain
Facility Name
Hospital de Viladecans
City
Barcelona
Country
Spain
Facility Name
Hospital General de Granollers
City
Barcelona
Country
Spain
Facility Name
Hospital Universitari de Bellvitge
City
Barcelona
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
Country
Spain
Facility Name
Hospital Santa Caterina
City
Girona
Country
Spain
Facility Name
Hospital General Riotinto
City
Huelva
Country
Spain
Facility Name
Hospital Quiron Sagrado Corazon
City
Sevilla
Country
Spain
Facility Name
Hospital Virgen del Rocío
City
Sevilla
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Comparative Study of PDVF and Polypropylene Transobturator Suburethral Tapes

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