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Sacral Neuromodulation with the InterStim System for Overactive Bladder: 3-Year Results from the French Prospective, Multicenter, Observational SOUNDS Study

التفاصيل البيبلوغرافية
العنوان: Sacral Neuromodulation with the InterStim System for Overactive Bladder: 3-Year Results from the French Prospective, Multicenter, Observational SOUNDS Study
المؤلفون: Marie-Aimée Perrouin-Verbe, Bertrand Rabut, Grégoire Capon, François Dargent, Evelyne Ragni, Christian Saussine, Elena Brassart, D.U.J. Keller, L. Peyrat, Marc Fourmarier, François Pecoux, Thierry Rousseau, Jean-Nicolas Cornu, N. Berrogain, A. Melotti, Najdat Yaghi, Yves Tanneau, Pierre-Emmanuel Bryckaert, A. Abouihia, Emmanuel Chartier-Kastler, Alain Ruffion, Raïssa Braguet, Gabriel Stoica, Jean Pierrevelcin, Xavier Gamé, Xavier Biardeau, Loïc Le Normand, Jean Pierre Graziana, Jérôme Ferchaud
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), HC Strasbourg, Strasbourg, France., CHP Saint Brieuc, Clinique Mutualiste de L'Orient, Hôpital de la Timone [CHU - APHM] (TIMONE), Polyclinique Courlancy, Reims, Clinique Urologie Nantes Atlantis, CHU Toulouse [Toulouse], Polyclinique Ormeau, Tarbes, Hopital Privé Sévigné [Cesson-Sévigné, France], Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Centre Hospitalier Intercommunal Alençon-Mamers (CHICAM), Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM), CHI Aix Pertuis CHPA-CHIAP, CH Sarreguemines France, CHU Bordeaux [Bordeaux], Hôpital privé Robert-Schuman, Metz, France., Clinique Ambroise Pare Toulouse, AP Hôpital Diaconesses, CHU Roubaix, Clinique Chirurgicale du Pré, LE MANS, Medtronic Diabetes, International Trading Sàrl , Tolochenaz, Switzerland, 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), UNIROUEN - UFR Santé (UNIROUEN UFR Santé), Normandie Université (NU)-Normandie Université (NU), Service d'urologie [Rouen], CHU Rouen, Normandie Université (NU)-Normandie Université (NU)-Université de Rouen Normandie (UNIROUEN), Normandie Université (NU), CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Medtronic Diabetes, International Trading Sàrl [Tolochenaz, Switzerland ] (MDITS), Normandie Université (NU)-Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), douville, sabine
المصدر: European Urology Focus
European Urology Focus, Elsevier, 2021, ⟨10.1016/j.euf.2021.06.013⟩
European Urology Focus, 2021, ⟨10.1016/j.euf.2021.06.013⟩
سنة النشر: 2021
مصطلحات موضوعية: medicine.medical_specialty, [SDV.MHEP.PHY] Life Sciences [q-bio]/Human health and pathology/Tissues and Organs [q-bio.TO], Urology, Urinary system, 030232 urology & nephrology, Electric Stimulation Therapy, Disease, urologic and male genital diseases, 03 medical and health sciences, 0302 clinical medicine, Quality of life, Disease severity, Numeric Rating Scale, [SDV.MHEP.PHY]Life Sciences [q-bio]/Human health and pathology/Tissues and Organs [q-bio.TO], Medicine, Humans, Prospective Studies, ComputingMilieux_MISCELLANEOUS, business.industry, Urinary Bladder, Overactive, medicine.disease, humanities, 3. Good health, Treatment Outcome, Overactive bladder, Sacral nerve stimulation, 030220 oncology & carcinogenesis, Physical therapy, Quality of Life, Observational study, business
الوصف: SOUNDS strengthens the evidence basis of sacral neuromodulation (SNM) for overactive bladder (OAB) through real-world data.To analyze diary-based effectiveness, quality of life (QoL), disease severity, symptom bother, and safety data for SNM with the InterStim system up to 3 yr after implantation.Twenty-five representative French sites enrolled 291 patients with OAB followed according to the local standard of care. Overall, 229 patients received a de novo or replacement InterStim implant and had four follow-up visits, two within the first yr and annually thereafter. A total of 190 patients completed the fourth follow-up visit after a mean of 33.7 ± 3.7 mo.The effectiveness outcomes measured were changes in daily voids and leaks and the therapy responder rates. Other outcomes included validated QoL data (Ditrovie and EuroQol 5-dimension 5-level questionnaires), disease severity (Urinary Symptom Profile [USP]), symptom bother rated using a numeric rating scale (NRS), and safety data. Follow-up data were compared to baseline results using the Wilcoxon signed-rank test.Average daily voids and leaks were significantly reduced at all time points up to 3 yr after implantation (p0.05) except for voids at 21 mo in the group receiving a replacement device. The therapeutic response for urinary urge incontinence at the fourth follow-up was 72% for the de novo group and 86% for the replacement group. Disease-specific QoL (Ditrovie), OAB-specific symptom severity (USP domain 2), and NRS-rated disease bother were significantly improved at all visits (p0.001). Device- or procedure-related adverse events occurred in 49% of patients, with 68% of the events classified as minor (Clavien-Dindo grade I or II). Surgical revisions were performed in 33% of patients, including permanent removal in 13%, over a mean exposure time of 44.4 ± 15.3 mo.This study confirms the safety and effectiveness of SNM for OAB and improvements in QoL and disease bother in real life.Our study in French patients with overactive bladder showed that disease symptoms and bother were significantly reduced and quality of life was significantly improved over a study duration of approximately 3 yr after implantation of a device to stimulate nerves that control the bladder. This trial is registered at ClinicalTrials.gov as NCT02186041.
تدمد: 2405-4569
URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::24431f912d5daf608dd522edffcc3943
https://pubmed.ncbi.nlm.nih.gov/34334342
حقوق: CLOSED
رقم الأكسشن: edsair.doi.dedup.....24431f912d5daf608dd522edffcc3943
قاعدة البيانات: OpenAIRE
الوصف
تدمد:24054569