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Polypropylene and polyvinylidene fluoride transobturator slings for the treatment of female stress urinary incontinence: 1‐Year outcomes from a multicentre randomized trial
Author(s) -
Sabadell Jordi,
PeredaNúñez Anna,
OjedadelosSantos Fernando,
Urbaneja Manuel,
GonzálezGarcía Carmen,
CampsLloveras Narcís,
PérezPlantado Àngela,
CanetRodríguez Judit,
PérezEspejo Maria Paz,
RodríguezMias Nuria,
SarasaCastelló Núria,
Palau Marta,
MonteroArmengol Anabel,
Salicrú Sabina,
GilMoreno Antonio,
Poza Jose L.
Publication year - 2021
Publication title -
neurourology and urodynamics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.918
H-Index - 90
eISSN - 1520-6777
pISSN - 0733-2467
DOI - 10.1002/nau.24586
Subject(s) - medicine , urinary incontinence , randomized controlled trial , confidence interval , odds ratio , incidence (geometry) , rate ratio , urology , surgery , physics , optics
Aims To compare the effectiveness and safety of polypropylene (PP) and polyvinylidene fluoride (PVDF) transobturator tapes (TOT) for the treatment of female stress urinary incontinence (SUI). Methods This is a multicentre randomized trial. Women with SUI or stress‐predominant mixed urinary incontinence and scheduled for a TOT procedure were randomized to PP or PVDF slings. The primary outcome was 1‐year cure or improvement rate using composite criteria. Complications were also compared. Relationships with outcomes were analyzed using multivariable logistic regressions models. Results From April 2016 to January 2018 285 participants were randomized. PP and PVDF slings showed similar high cure or improvement rate (91.0% vs. 95.6%, p = .138). Improvement in validated questionnaires was also similar. PVDF slings were associated with a lower rate of de novo urgency incontinence (adjusted odds ratio = 0.35; 95% confidence interval = 0.15–0.80). We found no statistical differences in complications rates, although a higher incidence of long‐term pain events were observed in the PP group. The study is underpowered to find differences in specific complications owing to the low number of events. Conclusion PP and PVDF TOTs are equally effective, although PVDF is associated with fewer cases of de novo urgency incontinence. Further studies are needed to give robust conclusions on safety profiles.