Sorbonne Université, Academic Hospital Pitié-Salpétrière, AP-HP, Paris, France.
CHU de Nantes - Hôtel Dieu, Nantes, France.
Eur Urol Focus. 2023 Sep;9(5):765-772. doi: 10.1016/j.euf.2023.03.008. Epub 2023 Apr 3.
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.
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.
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.
尽管骶神经调节（SNM）治疗膀胱过度活动症（OAB）已得到广泛认可，但目前缺乏真实世界实践中高质量、长期的数据。
报告真实世界中治疗效果、生活质量（QoL）、疾病严重程度和安全性，以及大约 5 年随访后患者报告的症状困扰情况。
设计、地点和参与者：共纳入 291 例 OAB 患者，在 25 个法国中心按照当地标准进行治疗。骶神经调节与 InterStim 治疗难治性下尿路功能障碍（SOUNDS）纳入了新发病例和更换治疗的患者，共有 229 例患者接受了永久性植入。
在研究过程中，患者共进行了 6 次随访，植入后第一年进行 2 次随访，此后每年随访一次。其中 154 例患者在平均 57.7±3.9 个月后完成了最终随访。
新发病例和更换治疗的急迫性尿失禁（UI）患者的每日漏尿次数分别从基线时的 4.4±3.3 次减少到 5 年后的 1.8±2.6 次（均 p<0.001）。同样，尿频患者的排尿次数也比基线时减少（新发病例：从 12.6±4.0[基线]减少到 9.6±4.3[5 年]；更换治疗：从 11.5±4.3[基线]减少到 9.2±3.1[5 年]；均 p<0.05）。5 年后，新发病例和更换治疗的急迫性 UI 患者完全控尿率分别为 44%（25/57）和 33%（5/15），急迫性 UI 患者中有>50%漏尿改善的治疗反应率分别为 68%（39/57）和 67%（10/15）。两组患者的疾病严重程度（尿症状特征 2 域）、基于数字评分量表的症状困扰和疾病特异性 QoL（Ditrovie）在所有随访中均显著改善（均 p<0.001）。与设备或手术相关的不良事件在 51%（140/274）的患者中发生，其中 66%（152/229）的事件被归类为轻度（Clavien-Dindo 分级 I 和 II）。报告了 39%（89/229）的手术修正，包括 15%（34/229）的患者永久性取出设备。
SOUNDS 证实了在真实世界环境下，SNM 治疗 OAB 患者在 5 年后仍具有持续的疗效和 QoL 改善，同时保持与文献一致的可接受的安全性。
本研究证实，法国 OAB 患者在骶神经调节设备植入后 5 年，症状和困扰持续减轻，生活质量得到改善。
