Sacral Neuromodulation Using a Novel Device with a Six-contactpoint Electrode for the Treatment of Patients with Refractory Overactive Bladder: A Multicenter, Randomized, Single-blind, Parallel-control Clinical Trial

被引：6

作者：

Liao, Limin ^{[1
,2
,3
,4
]}

Zhou, Zhonghan ^{[1
,2
,3
,4
]}

Chen, Guoqing ^{[1
,2
,3
]}

Xu, Zhihui ^{[5
]}

Huang, Banggao ^{[5
]}

Chong, Tie ^{[6
]}

Chen, Qi ^{[6
]}

Wei, Zhongqing ^{[7
]}

Shen, Baixin ^{[7
]}

Chen, Zhong ^{[8
]}

Ling, Qing ^{[8
]}

Weng, Zhiliang ^{[9
]}

Jiang, Haihong ^{[9
]}

Shi, Benkang ^{[10
]}

Li, Yan ^{[10
]}

Wang, Yiming ^{[1
,2
,3
]}

机构：

[1] China Rehabil Res Ctr, Dept Urol, Beijing, Peoples R China

[2] Capital Med Univ, Sch Rehabil, Beijing, Peoples R China

[3] Shandong Univ, Cheeloo Coll Med, Jinan, Shandong, Peoples R China

[4] Univ Hlth & Rehabil Sci, Qingdao, Peoples R China

[5] Zhejiang Prov Peoples Hosp, Dept Urol, Hangzhou, Peoples R China

[6] Nanjing Med Univ, Dept Urol, Affiliated Hosp 2, Nanjing, Peoples R China

[7] Xi An Jiao Tong Univ, Dept Urol, Affiliated Hosp 2, Xian, Peoples R China

[8] Huazhong Univ Sci Technol, Tongji Hosp, Dept Urol, Tongji Med Coll, Wuhan, Peoples R China

[9] Wenzhou Med Univ, Affiliated Hosp 1, Dept Urol, Wenzhou, Peoples R China

[10] Shandong Univ, Dept Urol, Qilu Hosp, Jinan, Peoples R China

来源：

EUROPEAN UROLOGY FOCUS | 2022年 / 8卷 / 06期

关键词：

Overactive bladder; Sacral neuromodulation; SacralStim system; Six-contact electrode; Randomized controlled trial; SYMPTOMS;

D O I：

10.1016/j.euf.2022.04.006

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: A novel sacral neuromodulation system (SacralStim) which has an electrode with six contact points was recently designed. Objective: To evaluate the effectiveness and safety of the SacralStim system for treating patients with refractory overactive bladder (OAB). Design, setting, and participants: This was a multicenter, randomized, single-blind clinical trial. Patients with refractory OAB were enrolled from January 2018 to May 2020. Intervention: Participants were randomly allocated to the treatment group (SNM on) or the control group (SNM off) for a single-blind period of 12 +/- 2 wk. Outcome measurements and statistical analysis: The primary outcome was the percentage of patients with a reduction in the average number of voids/24 h of at least 50% at the 12-wk follow-up visit. Other follow-up evaluations, including voiding diary outcomes, questionnaires on Overactive Bladder Symptom Score (OABSS), quality of life (QoL), device satisfaction, and causes of adverse events (AEs), were performed over the first 48 wk after implantation. Results and limitations: The therapeutic success rate at 12 wk was 56.76% in the treatment group and 11.11% in the control group (p < 0.001). There were significant differences in voiding diary variables between the two groups, including changes in the average number of voids/24 h, micturition volume/void, and improvement in the urge incontinence ratio. No severe AEs occurred. A limitation is the sham stimulation used as a control in the study. A head-to-head study is required to make a direct comparison of devices with six and four contact points. Conclusions: This clinical trial provides strong evidence that patients with refractory OAB benefit from the novel SacralStim system. More research is required for direct comparison of the SacralStim system with traditional four-contact-point devices. Patient summary: This study confirms the effectiveness and safety of a novel SacralStim system that stimulates the sacral nerve for treatment of overactive bladder. The system has an electrode with six contact points and can provide more programming options after implantation. (c) 2022 European Association of Urology. Published by Elsevier B.V. All rights reserved.

引用

页码：1823 / 1830

页数：8