Sistema de Salut de Catalunya
[Sabadell J] 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. [Pereda-Núñez A, Sarasa-Castelló N] Pelvic Floor Unit, Department of Obstetrics and Gynecology, Hospital General de Granollers, Granollers, Spain. [Ojeda-de-Los-Santos F] Department of Gynecology, Hospital Quirón Sagrado Corazón, Sevilla, Spain. [Urbaneja M] Department of Gynecology, Hospital Virgen del Rocío, Sevilla, Spain. [González-García C] Department of Gynecology, Hospital de Viladecans, Barcelona, Spain. [Camps-Lloveras N] Functional Urology and Urodynamics Unit, Department of Urology, Hospital Universitari de Bellvitge, Universitat de Barcelona, Barcelona, Spain
Hospital General de Granollers
2021-11-25T10:27:10Z
2021-11-25T10:27:10Z
2021-01
Polypropylene; Polyvinylidene fluoride; Stress urinary incontinence
Polipropileno; Fluoruro de polivinilideno; Incontinencia urinaria de esfuerzo
Polipropilè; Fluorur de polivinilidè; Incontinència urinària d'esforç
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.
Article
Published version
English
Incontinència urinària; Polipropilè; Dones; DISEASES::Female Urogenital Diseases and Pregnancy Complications::Female Urogenital Diseases::Urologic Diseases::Urination Disorders::Urinary Incontinence::Urinary Incontinence, Stress; CHEMICALS AND DRUGS::Biomedical and Dental Materials::Polymers::Plastics::Polypropylenes; ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Surgical Procedures, Operative::Urogenital Surgical Procedures::Urologic Surgical Procedures; ENFERMEDADES::enfermedades de los genitales femeninos y complicaciones del embarazo::enfermedades urogenitales femeninas::enfermedades urológicas::trastornos urinarios::incontinencia urinaria::incontinencia urinaria de esfuerzo; COMPUESTOS QUÍMICOS Y DROGAS::materiales biomédicos y dentales::polímeros::plásticos::polipropilenos; TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::intervenciones quirúrgicas::procedimientos quirúrgicos urogenitales::procedimientos quirúrgicos urológicos
Wiley
Neurourology and Urodynamics;40(1)
https://doi.org/10.1002/nau.24586
Attribution-NonCommercial-ShareAlike 4.0 International
http://creativecommons.org/licenses/by-nc-sa/4.0/
