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

被引：6

作者：

Chartier-Kastler, Emmanuel ^{[1
,28
]}

Le Normand, Loic ^{[2
]}

Ruffion, Alain ^{[3
]}

Saussine, Christian ^{[4
]}

Braguet, Raissa ^{[5
]}

Rabut, Bertrand ^{[6
]}

Ragni, Evelyne ^{[7
]}

Perrouin-Verbe, Marie-Aimee ^{[2
]}

Pierrevelcin, Jean ^{[8
]}

Rousseau, Thierry ^{[9
]}

Game, Xavier ^{[10
]}

Tanneau, Yves ^{[11
]}

Dargent, Francois ^{[12
]}

Biardeau, Xavier ^{[13
]}

Graziana, Jean Pierre ^{[6
]}

Stoica, Gabriel ^{[14
]}

Brassart, Elena ^{[15
]}

Fourmarier, Marc ^{[16
]}

Yaghi, Najdat ^{[17
]}

Capon, Gregoire ^{[18
]}

Ferchaud, Jerome ^{[19
]}

Berrogain, Nathalie ^{[20
]}

Peyrat, Laurence ^{[21
]}

Pecoux, Francois ^{[22
]}

Bryckaert, Pierre-Emmanuel ^{[23
]}

Karsenty, Gilles ^{[24
]}

Song, Shannon ^{[25
]}

Keller, David Urs Josef ^{[26
]}

Cornu, Jean-Nicolas ^{[27
]}

机构：

[1] Sorbonne Univ, Dept Neurol, Pitie Salpetriere Acad Hosp, AP HP, Paris, France

[2] CHU Nantes, Hotel Dieu, Nantes, France

[3] CH Lyon Sud, Haematol Serv, Lyon, France

[4] IHU Strasbourg, Strasbourg, France

[5] CHP St Brieuc, St Brieuc, France

[6] CHBS Lorient, Lorient, France

[7] Hop Univ Marseille, Serv Pharmacol Clin, Ctr Evaluat & Informat Pharmacodependance Addicto, Marseille, France

[8] Polyclin Courlancy, Reims, France

[9] Clin Nantes Atlantis, Urol, St Herblain, France

[10] CHU Toulouse, Hop Rangueil, Toulouse, France

[11] Polyclin Ormeau, Tarbes, France

[12] Hop Foch, Suresnes, France

[13] CHRU LILLE, Lille, France

[14] CH Alencon, Alencon, France

[15] CHU Angers, Angers, France

[16] CHI Aix Pertuis CHPA CHIAP, Aix En Provence, France

[17] CH Sarreguemines, Sarreguemines, France

[18] CHU Bordeaux, Bordeaux, France

[19] Hop Robert Schuman, CH Metz, Metz Vantoux, France

[20] Clin Ambroise Pare, Toulouse, France

[21] Hop Tenon, AP HP, Paris, France

[22] CH Roubaix, Roubaix, France

[23] Clin Chirurg Pre, Dept Urol, Le Mans, France

[24] Aix Marseille Univ, Concept Acad Hosp, AP HM, Dept Anesthesiol & Reanimat, Marseille, France

[25] CEPR, Minneapolis, MN 55455 USA

[26] Medtronic, Tolochenaz, Switzerland

[27] CHU Charles Nicolle, Pediat, Rouen, France

[28] Sorbonne Univ, Hop Univ Pitie Salpetriere, Urol, 47-83 Blvd Hop, Paris, France

来源：

EUROPEAN UROLOGY FOCUS | 2023年 / 9卷 / 05期

关键词：

Overactive bladder; Real world; Sacral neuromodulation; Urinary urge incontinence; Urinary frequency; URINARY-INCONTINENCE; SYMPTOMS;

D O I：

10.1016/j.euf.2023.03.008

中图分类号：

R5 [内科学]; R69 [泌尿科学（泌尿生殖系疾病）];

学科分类号：

1002 ; 100201 ;

摘要：

Background: 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.Objective: 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.Design, setting, and participants: 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.Outcome measurements and statistical analysis: 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.Results and limitations: 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.Conclusions: 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.Patient summary: 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.

引用

页码：765 / 772

页数：8