Polypropylene and polyvinylidene fluoride transobturator slings for the treatment of female stress urinary incontinence: 1-Year outcomes from a multicentre randomized trial.
Neurourol Urodyn
; 40(1): 475-482, 2021 01.
Article
em En
| MEDLINE
| ID: mdl-33259073
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.
Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Polipropilenos
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Polivinil
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Procedimentos Cirúrgicos Urológicos
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Incontinência Urinária
Tipo de estudo:
Clinical_trials
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Prognostic_studies
Limite:
Aged
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Revista:
Neurourol Urodyn
Ano de publicação:
2021
Tipo de documento:
Article
País de afiliação:
Espanha
País de publicação:
Estados Unidos