Polypropylene and polyvinylidene fluoride transobturator slings for the treatment of female stress urinary incontinence: 1-Year outcomes from a multicentre randomized trial.

Jordi Sabadell, Anna Pereda-Núñez, Fernando Ojeda-de-Los-Santos, Manuel Urbaneja, Carmen González-García, Narcís Camps-Lloveras, Àngela Pérez-Plantado, Judit Canet-Rodríguez, Maria Paz Pérez-Espejo, Nuria Rodríguez-Mias, Núria Sarasa-Castelló, Marta Palau, Anabel Montero-Armengol, Sabina Salicrú, Antonio Gil-Moreno, Jose L Poza

Journal: Neurourology and urodynamics 2021;40(1):475-482

PMID: 33259073

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Abstract

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.

Address: Urogynecology and Pelvic Floor Unit, Department of Gynecology, Hospital Universitari Vall d'Hebron, Vall d'Hebron Barcelona Hospital Campus, Universitat Autònoma de Barcelona, Barcelona, Spain.; General Surgery Research Group, Vall d'Hebron Institut de Recerca, Vall d'Hebron Barcelona Hospital Campus, Universitat Autònoma de Barcelona, Barcelona, Spain.; Pelvic Floor Unit, Department of Obstetrics and Gynecology, Hospital General de Granollers, Barcelona, Spain.; Department of Gynecology, Hospital Quirón Sagrado Corazón, Sevilla, Spain.; Department of Gynecology, Hospital Virgen del Rocío, Sevilla, Spain.; Department of Gynecology, Hospital de Viladecans, Barcelona, Spain.; Functional Urology and Urodynamics Unit, Department of Urology, Hospital Universitari de Bellvitge, Universitat de Barcelona, Barcelona, Spain.; Department of Gynecology, Hospital de Mataró, Consorci Sanitari del Maresme, Barcelona, Spain.; Department of Gynecology, Hospital Santa Caterina de Salt, Girona, Spain.; Department of Urology, Hospital General de Riotinto, Huelva, Spain.; Department of Gynecology, Hospital Universitari Vall d'Hebron, Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain.; Biomedical Research Group in Gynecology, Vall d'Hebron Institut de Recerca, Vall d'Hebron Barcelona Hospital Campus, Universitat Autònoma de Barcelona, Barcelona, Spain.; Centro de Investigación Biomédica en Red (CIBERONC), Instituto de Salud Carlos III, Madrid, Spain.

DOI: 10.1002/nau.24586

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https://doi.org/10.1002/nau.24586

MeSH Terms: Aged, Female, Humans, Middle Aged, Polypropylenes, Polyvinyls, Surveys and Questionnaires, Treatment Outcome, Urinary Incontinence, Urinary Incontinence, Stress, Urologic Surgical Procedures