Comparative Study of PDVF and Polypropylene Transobturator Suburethral Tapes

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02886520

Enrollment

286

Registered

2016-09-01

Start date

2016-04-30

Completion date

2019-04-30

Last updated

2019-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Stress Incontinence

Keywords

Urinary incontinence, Materials, Surgery, Transobturator tape, Polyvinylidene fluoride, Polypropylene

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.

Interventions

DEVICEPVDF transobturator tape

DEVICEPolypropylene transobturator tape

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 90 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Effectiveness	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

Measure	Time frame	Description
Number of participants with adverse events	Up to one year.	Comparison of the intra- and postoperative complications between both procedures.

Other

Measure	Time frame	Description
Change in subjective questionnaires of incontinence severity	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.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026