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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

Emmanuel Chartier-Kastler 1 Loïc Le Normand 2 Alain Ruffion 3 François Dargent 4 Raïssa Braguet 5 Christian Saussine 6 Yves Tanneau 7 Jean Pierre Graziana 8 Evelyne Ragni 9 Bertrand Rabut 8 Thierry Rousseau 10 Xavier Biardeau 11 Xavier Gamé 12 Jean Pierrevelcin 13 Elena Brassart 14 Marc Fourmarier 15 Gabriel Stoica 16 Nathalie Berrogain 17 Najdat Yaghi 18 François Pecoux 19 Gregoire Capon 20 Jérôme Ferchaud 21 Laurence Peyrat 22 Pierre Emmanuel Bryckaert 23 Gilles Karsenty 24 Alice Melotti 25 Abdallah Abouihia 25 David Urs Josef Keller 25 Jean-Nicolas Cornu 26, 27, 28, 29 
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
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https://hal-normandie-univ.archives-ouvertes.fr/hal-02960057
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Submitted on : Wednesday, October 7, 2020 - 12:40:21 PM
Last modification on : Friday, August 5, 2022 - 3:36:23 AM

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Emmanuel Chartier-Kastler, Loïc Le Normand, Alain Ruffion, François Dargent, Raïssa Braguet, et al.. 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. European Urology Focus, 2021, 7 (6), pp.1430-1437. ⟨10.1016/j.euf.2020.06.026⟩. ⟨hal-02960057⟩

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