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Sacral Neuromodulation with the InterStim™ System for Intractable Lower Urinary Tract Dysfunctions (SOUNDS): Results of Clinical Effectiveness, Quality of Life, Patient-Reported Outcomes and Safety in a French Multicenter Observational Study

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العنوان: Sacral Neuromodulation with the InterStim™ System for Intractable Lower Urinary Tract Dysfunctions (SOUNDS): Results of Clinical Effectiveness, Quality of Life, Patient-Reported Outcomes and Safety in a French Multicenter Observational Study
المؤلفون: François Dargent, Raïssa Braguet, Emmanuel Chartier-Kastler, Xavier Biardeau, D.U.J. Keller, Alain Ruffion, Christian Saussine, Gilles Karsenty, Gabriel Stoica, Jérôme Ferchaud, N. Berrogain, Jean Pierre Graziana, Thierry Rousseau, Grégoire Capon, Elena Brassart, Jean-Nicolas Cornu, Najdat Yaghi, Loïc Le Normand, Xavier Gamé, A. Abouihia, François Pecoux, Yves Tanneau, Evelyne Ragni, A. Melotti, Pierre Emmanuel Bryckaert, L. Peyrat, Jean Pierrevelcin, Bertrand Rabut, Marc Fourmarier
المساهمون: Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Centre hospitalier universitaire de Nantes (CHU Nantes), Centre Hospitalier Lyon Sud [CHU - HCL] (CHLS), Hospices Civils de Lyon (HCL), Hopital Privé Sévigné [Cesson-Sévigné, France], CHU de Saint-Brieuc, CHU Strasbourg, Polyclinique de l'Ormeau, Clinique Mutualiste de L'Orient, Hôpital Nord [CHU - APHM], Clinique Urologie Nantes Atlantis, Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), CHU Toulouse [Toulouse], Polyclinique Courlancy (PC), Polyclinique de Courlancy, Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM), Centre Hospitalier d'Aix en Provence [Aix-en-Provence] (CHIAP ), CHIC Aleçon Mamers, Clinique Ambroise Pare Toulouse, CH Sarreguemines France, CHU Roubaix, CHU Bordeaux [Bordeaux], CH Metz -Robert Schuman Vantoux, AP Hôpital Diaconesses, Clinique du Pré, APM Hôpital de la Conception, Medtronic International Trading Sarl [Tolochenaz], Nutrition, inflammation et dysfonctionnement de l'axe intestin-cerveau (ADEN), Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Institute for Research and Innovation in Biomedicine (IRIB), Normandie Université (NU)-Normandie Université (NU)-Centre National de la Recherche Scientifique (CNRS)-Institut National de la Santé et de la Recherche Médicale (INSERM), Service d'urologie [Rouen], CHU Rouen, Normandie Université (NU)-Normandie Université (NU)-Université de Rouen Normandie (UNIROUEN), Normandie Université (NU), UNIROUEN - UFR Santé (UNIROUEN UFR Santé), Normandie Université (NU)-Normandie Université (NU), douville, sabine, CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Normandie Université (NU)-Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)
المصدر: European Urology Focus
European Urology Focus, Elsevier, 2020, ⟨10.1016/j.euf.2020.06.026⟩
European Urology Focus, 2021, 7 (6), pp.1430-1437. ⟨10.1016/j.euf.2020.06.026⟩
بيانات النشر: HAL CCSD, 2020.
سنة النشر: 2020
مصطلحات موضوعية: medicine.medical_specialty, Urology, Urinary system, 030232 urology & nephrology, Electric Stimulation Therapy, Disease, [SDV.MHEP.UN]Life Sciences [q-bio]/Human health and pathology/Urology and Nephrology, 03 medical and health sciences, 0302 clinical medicine, Quality of life, Internal medicine, medicine, Humans, Patient Reported Outcome Measures, Prospective Studies, Adverse effect, Non-obstructive urinary retention, ComputingMilieux_MISCELLANEOUS, Urinary retention, business.industry, Urinary Bladder, Overactive, Overactive bladder, Sacral neuromodulation, Urinary Incontinence, Urge, medicine.disease, Double incontinence, [SDV.MHEP.UN] Life Sciences [q-bio]/Human health and pathology/Urology and Nephrology, humanities, 3. Good health, Treatment Outcome, Sacral nerve stimulation, 030220 oncology & carcinogenesis, Quality of Life, Observational study, medicine.symptom, business
الوصف: International audience; BackgroundReal-world data that support the use of sacral neuromodulation (SNM) for lower urinary tract dysfunctions are of continued interest.ObjectiveTo evaluate the effectiveness, quality of life (QoL), patient-reported outcomes (PROs), and safety of SNM with the InterStim™ system in real life during 1-yr postimplant.Design, setting, and participantsThis is a prospective, multicenter, observational study at 25 representative public and private French sites. Eligible patients received SNM therapy for overactive bladder (OAB) and non-obstructive urinary retention based on local standard of care. Overall, 320 patients were enrolled; 247 received permanent implant or replacement; 204 implanted patients completed second follow-up after mean of 10.0 ± 3.8 mo.Outcome measurements and statistical analysisEffectiveness outcomes were change in voids, leaks, and catheterizations/day. Other outcomes included validated QoL and disease severity scores as well as PROs and adverse event data. Outcomes at follow-ups were compared with baseline using the Wilcoxon signed-rank test.Results and limitationsVoids in urinary frequency (UF) and leaks/day in urinary urge incontinence (UI) patients were significantly reduced after 10 mo in both de novo (mean baseline voids/day UF de novo: 12.7 vs 8.6 after 10 mo; p < 0.001; mean baseline leaks/day UI de novo: 4.3 vs 1.1 after 10 mo; p < 0.001) and replacement patients (mean baseline voids/day UF replacement: 11.5 vs 7.9 after 10 mo; p < 0.001; mean baseline leaks/day UI replacement: 5.4 vs 1.0 after 10 mo; p < 0.001). Disease bother, Urinary Symptom Profile score, and Ditrovie questionnaire score were also significantly improved. Revisions postimplant occurred in 20% of patients including in 9% due to permanent explantation during a mean exposure time of 24.3 mo.ConclusionsThrough a real-life study, SOUNDS (Sacral neuromOdUlation with InterStim™ therapy for intractable lower uriNary tract DySfunctions) confirms the clinical effectiveness, safety, and positive effect of SNM on QoL and PROs for the treatment of OAB patients.Patient summaryThese analyses on French patients who received sacral neuromodulation (SNM) for retention or OAB during a 10-mo period showed that SNM improved OAB symptoms, quality of life, and reduced disease bother.Trial registrationClinicalTrials.gov: NCT02186041
اللغة: English
تدمد: 2405-4569
URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::9749287799903b4d48d851c570666b24
https://hal-normandie-univ.archives-ouvertes.fr/hal-02960057
حقوق: OPEN
رقم الأكسشن: edsair.doi.dedup.....9749287799903b4d48d851c570666b24
قاعدة البيانات: OpenAIRE
الوصف
تدمد:24054569