Comparative Study of PDVF and Polypropylene Transobturator Suburethral Tapes

Urinary Stress Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02886520
• Other study ID #: PR(AMI)241-2015
• Status: Completed
• Phase: Phase 4
• Start date: April 2016
• Est. completion date: April 2019

Study information

• Verified date: July 2019
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 286
• Est. completion date: April 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Urinary Incontinence
• Urinary Incontinence, Stress
• Urinary Stress Incontinence

Intervention

Device:
• PVDF transobturator tape

• Polypropylene transobturator tape

Locations

Country	Name	City	State
Spain	Hospital de Mataró	Barcelona
Spain	Hospital de Viladecans	Barcelona
Spain	Hospital General de Granollers	Barcelona
Spain	Hospital Universitari de Bellvitge	Barcelona
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	Hospital Santa Caterina	Girona
Spain	Hospital General Riotinto	Huelva
Spain	Hospital Quiron Sagrado Corazon	Sevilla
Spain	Hospital Virgen del Rocío	Sevilla

Sponsors (9)

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

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in subjective questionnaires of incontinence severity	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.	One year
Primary	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	Number of participants with adverse events	Comparison of the intra- and postoperative complications between both procedures.	Up to one year.