Five-year Results from the Prospective, Multicenter, Observational SOUNDS Study of Patients with Overactive Bladder Treated with the InterStim System for Sacral Neuromodulation.

Although sacral neuromodulation (SNM) for overactive bladder (OAB) is an established therapy, there is a lack of high-quality, long-term data on real-life practice.

To report on real-life therapeutic effectiveness, quality of life (QoL), disease severity, and safety as well as patient-reported symptom bother after approximately 5 yr of follow-up.

A total of 291 OAB patients were enrolled at 25 French sites according to local standard of care. Sacral neuromOdUlation with InterStim therapy for intractable lower uriNary tract DySfunctions (SOUNDS) enrolled both de novo and replacement patients, and a total of 229 patients were permanently implanted.

Over the course of the study, patients were followed up six times with two follow-ups in the year after implantation and annually thereafter. Of the patients, 154 completed the final follow-up after a mean of 57.7 ± 3.9 mo.

The mean number of daily leaks in urinary urge incontinence (UI) patients was reduced from 4.4 ± 3.3 at baseline to 1.8 ± 2.6 after 5 yr in de novo and from 5.4 ± 4.9 to 2.2 ± 3.0 in replacement patients (both p < 0.001). Likewise, the number of voids in urinary frequency patients was reduced compared with baseline (de novo: reduced from 12.6 ± 4.0 [baseline] to 9.6 ± 4.3 [5 yr]; replacements: reduced from 11.5 ± 4.3 [baseline] to 9.2 ± 3.1 [5 yr]; both p < 0.05). Complete continence rates after 5 yr were 44% (25/57) in de novo and 33% (5/15) in replacement UI patients, and 68% (39/57) and 67% (10/15) of UI patients were categorized as therapy responders by showing a >50% improvement in leaks. Disease severity (Urinary Symptom Profile domain 2), Numeric Rating Scale-based symptom bother, and disease-specific QoL (Ditrovie) improved significantly in both groups at all visits (p < 0.001). Adverse events related to device or procedure occurred in 51% (140/274) of patients, with 66% (152/229) of the events being classified as minor (Clavien-Dindo grade I and II). Surgical revisions were reported in 39% (89/229), which include permanent explants in 15% (34/229) of patients.

SOUNDS demonstrates the sustained effectiveness and QoL improvements of SNM in OAB patients after 5 yr in real-world conditions while maintaining an acceptable safety profile consistent with literature.

This study confirmed that French overactive bladder patients had a sustained symptom and bother reduction, and improvements in quality of life up to 5 yr after sacral neuromodulation device implantation.

European urology focus. 2023 Apr 03 [Epub ahead of print]

Emmanuel Chartier-Kastler, Loïc Le Normand, Alain Ruffion, Christian Saussine, Raïssa Braguet, Bertrand Rabut, Evelyne Ragni, Marie-Aimée Perrouin-Verbe, Jean Pierrevelcin, Thierry Rousseau, Xavier Gamé, Yves Tanneau, François Dargent, Xavier Biardeau, Jean Pierre Graziana, Gabriel Stoica, Elena Brassart, Marc Fourmarier, Najdat Yaghi, Gregoire Capon, Jérôme Ferchaud, Nathalie Berrogain, Laurence Peyrat, François Pecoux, Pierre-Emmanuel Bryckaert, Gilles Karsenty, Shannon Song, David Urs Josef Keller, Jean-Nicolas Cornu

Sorbonne Université, Academic Hospital Pitié-Salpétrière, AP-HP, Paris, France. Electronic address: ., CHU de Nantes - Hôtel Dieu, Nantes, France., CH Lyon Sud, Lyon, France., HC Strasbourg, Strasbourg, France., CHP Saint Brieuc, Saint Brieuc, France., Clinique Mutualiste Lorient, Lorient, France., Hôpital de la Timone - Centre Hôspitalier Universitaire de Marseille, France., Polyclinique Courlancy, Reims, France., Clinique Urologie Nantes Atlantis, Saint Herblain, France., CHU Toulouse Hôpital Rangueil, Toulouse, France., Polyclinique Ormeau, Tarbes, France., Hôpital Privé Sevigné - Cesson Sevigné, France., CHRU Lille, Lille, France., CHIC Alencon Mamers, Alençon, France., CHU Angers, Angers, France., CHI Aix Pertuis CHPA-CHIAP, Aix en Provence, France., CH Sarreguemines, Sarreguemines, France., CHU Bordeaux, Bordeaux, France., CH Metz - Robert Schuman, Metz Vantoux, France., Clinique Ambroise Pare, Toulouse, France., AP Hôpital Diaconesses, Paris, France., CH Roubaix, Roubaix, France., Clinique Chirurgicale du Pré, Le Mans, France., Aix-Marseille University, Academic Hospital la Conception, AP-HM, Marseille, France., Medtronic Global Clinical Data Solutions, Minneapolis, MN, USA., Medtronic, Tolochenaz, Switzerland., CHU de Rouen - Hôpital Charles Nicolle, France.