NCT02886520

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
286

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 2016

Typical duration for phase_4

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 27, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 1, 2016

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

July 26, 2019

Status Verified

July 1, 2019

Enrollment Period

3 years

First QC Date

August 27, 2016

Last Update Submit

July 25, 2019

Conditions

Urinary Stress Incontinence

Keywords

Urinary incontinenceMaterialsSurgeryTransobturator tapePolyvinylidene fluoridePolypropylene

Outcome Measures

Primary Outcomes (1)

  • 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".

    One year

Secondary Outcomes (1)

  • Number of participants with adverse events

    Up to one year.

Other Outcomes (1)

  • Change in subjective questionnaires of incontinence severity

    One year

Study Arms (2)

PVDF transobturator tape

ACTIVE COMPARATOR

Transobturator tension-free suburethral tape made of polyvinylidene fluoride.

Device: PVDF transobturator tape

PP transobturator tape

ACTIVE COMPARATOR

Transobturator tension-free suburethral tape made of polypropylene.

Device: Polypropylene transobturator tape

Interventions

PVDF transobturator tapeDEVICE
Also known as: Dynamesh-SIS
PVDF transobturator tape
Polypropylene transobturator tapeDEVICE
PP transobturator tape

Eligibility Criteria

Age18 Years - 90 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women with stress urinary incontinence.
  • Women with stress-predominant mixed urinary incontinence.

You may not qualify if:

  • Incapacity to understand the information or give their consent.
  • Previous anti-incontinence surgery with slings.
  • Low pressure urethra (MUCP \< 20cmH2O).
  • Neurogenic bladder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Hospital de Mataró

Barcelona, Spain

Location

Hospital de Viladecans

Barcelona, Spain

Location

Hospital General de Granollers

Barcelona, Spain

Location

Hospital Universitari de Bellvitge

Barcelona, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Location

Hospital Santa Caterina

Girona, Spain

Location

Hospital General Riotinto

Huelva, Spain

Location

Hospital Quiron Sagrado Corazon

Seville, Spain

Location

Hospital Virgen del Rocío

Seville, Spain

Location

MeSH Terms

Conditions

Urinary Incontinence, StressUrinary Incontinence

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2016

First Posted

September 1, 2016

Study Start

April 1, 2016

Primary Completion

April 1, 2019

Study Completion

April 1, 2019

Last Updated

July 26, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

ES(9)