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
Year: 2020
Type: article
Study design: Observational Study
Abstract: BACKGROUND: Real-world data that support the use of sacral neuromodulation (SNM) for lower urinary tract dysfunctions are of continued interest. OBJECTIVE: To 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 PARTICIPANTS: This 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 ANALYSIS: Effectiveness 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 LIMITATIONS: Voids 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. CONCLUSIONS: Through 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 SUMMARY: These 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 REGISTRATION: ClinicalTrials.gov: NCT02186041.
Source: European Urology Focus
Authors: Emmanuel Chartier-Kastler, Loïc Le Normand, Alain Ruffion, François Dargent, Raïssa Braguet, Christian Saussine, Yves Tanneau, Jean Pierre Graziana, Evelyne Ragni, Bertrand Rabut, Thierry Rousseau, Xavier Biardeau, Xavier Gamé, Jean Pierrevelcin, Elena Brassart, Marc Fourmarier, Gabriel Stoica, Nathalie Berrogain, Najdat Yaghi, François Pecoux, Gregoire Capon, Jérôme Ferchaud, Laurence Peyrat, Pierre Emmanuel Bryckaert, Gilles Karsenty, Alice Melotti, Abdallah Abouihia, David Urs Josef Keller, Jean-Nicolas Cornu
Institutions: Sorbonne Université, Assistance Publique – Hôpitaux de Paris, Pitié-Salpêtrière Hospital, Centre Hospitalier Universitaire de Nantes, Nantes Université, Hospices Civils de Lyon, Hôpital Lyon Sud, Sebia (France), Centre Hospitalier de Saint-Brieuc, Hôpitaux Universitaires de Strasbourg, Groupe Hospitalier Mutualiste de Grenoble, Assistance Publique Hôpitaux de Marseille, Hôpital Nord, Centre Hospitalier Universitaire de Lille, Centre Hospitalier Universitaire de Toulouse, Hôpital Rangueil, Hôpital Purpan, Hôpital Paule de Viguier, Hôpital de La Grave, L’Institut du Cancer Courlancy Reims, Centre Hospitalier Universitaire d'Angers, Centre Hospitalier Intercommunal Aix-Pertuis, Clinique Ambroise Paré, Centre Hospitalier de Roubaix, Centre Hospitalier Universitaire de Bordeaux, Hôpital des Diaconesses, Hôpital de la Conception, Medtronic (Switzerland), Hôpital Charles-Nicolle, Institute for Research and Innovation in Biomedicine, Nutrition, Inflammation et axe Microbiote-Intestin-Cerveau, Université de Rouen Normandie
Language: English
Subfield: Urology
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $3,000
OpenAlex ID: W3084252201