Comparative Study of PDVF and Polypropylene Transobturator Suburethral Tapes

Vall d'Hebron University Hospital (HUVH)

Status and phase: Completed; Phase 4

Conditions: Urinary Stress Incontinence

Treatments: Device: Polypropylene transobturator tape; Device: PVDF transobturator tape

Study type: Interventional

Funder types: Other

Identifiers

NCT02886520

PR(AMI)241-2015

Details and patient eligibility

About

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.

Enrollment: 286 patients

Sex: Female

Ages: 18 to 90 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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286 participants in 2 patient groups

PVDF transobturator tape

Active Comparator group

Description:

Transobturator tension-free suburethral tape made of polyvinylidene fluoride.

Treatment:

Device: PVDF transobturator tape

PP transobturator tape

Active Comparator group

Description:

Transobturator tension-free suburethral tape made of polypropylene.

Treatment:

Device: Polypropylene transobturator tape