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

Authors
  • Chartier-Kastler, Emmanuel1
  • Normand, Loïc Le2
  • Ruffion, Alain3
  • Saussine, Christian4
  • Braguet, Raïssa5
  • Rabut, Bertrand6
  • Ragni, Evelyne7
  • Perrouin-Verbe, Marie-Aimée2
  • Pierrevelcin, Jean8
  • Rousseau, Thierry9
  • Gamé, Xavier10
  • Tanneau, Yves11
  • Dargent, François12
  • Biardeau, Xavier13
  • Graziana, Jean Pierre6
  • Stoica, Gabriel14
  • Brassart, Elena15
  • Fourmarier, Marc16
  • Yaghi, Najdat17
  • Capon, Gregoire18
  • And 9 more
  • 1 Sorbonne Université, Academic Hospital Pitié-Salpétrière, AP-HP, Paris, France. Electronic address: [email protected] , (France)
  • 2 CHU de Nantes, Hôtel Dieu, Nantes, France. , (France)
  • 3 CH Lyon Sud, Lyon, France. , (France)
  • 4 HC Strasbourg, Strasbourg, France. , (France)
  • 5 CHP Saint Brieuc, Saint Brieuc, France. , (France)
  • 6 Clinique Mutualiste Lorient, Lorient, France. , (France)
  • 7 Hôpital de la Timone, Centre Hôspitalier Universitaire de Marseille, Marseille, France. , (France)
  • 8 Polyclinique Courlancy, Reims, France. , (France)
  • 9 Clinique Urologie Nantes Atlantis, Saint Herblain, France. , (France)
  • 10 CHU Toulouse Hôpital Rangueil, Toulouse, France. , (France)
  • 11 Polyclinique Ormeau, Tarbes, France. , (France)
  • 12 Hôpital Privé Sevigné, Cesson Sevigné, France. , (France)
  • 13 CHRU Lille, Lille, France. , (France)
  • 14 CHIC Alencon Mamers, Alençon, France. , (France)
  • 15 CHU Angers, Angers, France. , (France)
  • 16 CHI Aix Pertuis CHPA-CHIAP, Aix en Provence, France. , (France)
  • 17 CH Sarreguemines, Sarreguemines, France. , (France)
  • 18 CHU Bordeaux, Bordeaux, France. , (France)
  • 19 CH Metz, Hôpital Robert Schuman, Metz Vantoux, France. , (France)
  • 20 Clinique Ambroise Pare, Toulouse, France. , (France)
  • 21 AP Hôpital Diaconesses, Paris, France. , (France)
  • 22 CH Roubaix, Roubaix, France. , (France)
  • 23 Clinique Chirurgicale du Pré, Le Mans, France. , (France)
  • 24 Medtronic, Tolochenaz, Switzerland. , (Switzerland)
  • 25 CHU de Rouen, Hôpital Charles Nicolle, Rouen, France. , (France)
Type
Published Article
Journal
European urology focus
Publication Date
Jul 29, 2021
Identifiers
DOI: 10.1016/j.euf.2021.06.013
PMID: 34334342
Source
Medline
Keywords
Language
English
License
Unknown

Abstract

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 (p < 0.05) 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 (p < 0.001). 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. Copyright © 2021. Published by Elsevier B.V.

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