Department of Urology, China Rehabilitation Research Center, Beijing, China; School of Rehabilitation, Capital Medical University, Beijing, China; Cheeloo College of Medicine, Shandong University, Jinan, Shandong, China; University of Health and Rehabilitation Sciences, Qingdao, China.
Department of Urology, China Rehabilitation Research Center, Beijing, China; School of Rehabilitation, Capital Medical University, Beijing, China; Cheeloo College of Medicine, Shandong University, Jinan, Shandong, China; University of Health and Rehabilitation Sciences, Qingdao, China.
Eur Urol Focus. 2022 Nov;8(6):1823-1830. doi: 10.1016/j.euf.2022.04.006. Epub 2022 May 4.
A novel sacral neuromodulation system (SacralStim) which has an electrode with six contact points was recently designed.
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.
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.
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.
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.
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.
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.
最近设计了一种新型骶神经调节系统（SacralStim），该系统的电极有六个触点。
评估 SacralStim 系统治疗难治性膀胱过度活动症（OAB）患者的有效性和安全性。
设计、地点和参与者：这是一项多中心、随机、单盲临床试验。2018 年 1 月至 2020 年 5 月，招募了难治性 OAB 患者。
参与者被随机分配到治疗组（SNM 开启）或对照组（SNM 关闭），进行为期 12±2 周的单盲期。
主要结局是在 12 周随访时，至少有 50%的患者平均排尿次数/24 h 减少的患者比例。在植入后的前 48 周，还进行了其他随访评估，包括排尿日记结果、膀胱过度活动症症状评分（OABSS）问卷、生活质量（QoL）、设备满意度和不良事件（AE）的原因。
治疗组的治疗成功率为 56.76%，对照组为 11.11%（p<0.001）。两组间排尿日记变量有显著差异，包括平均排尿次数/24 h、每次排尿量/排尿和急迫性尿失禁比例的改善。无严重 AE 发生。局限性在于研究中使用的假刺激作为对照。需要进行头对头研究以直接比较具有六个和四个触点的设备。
这项临床试验提供了有力证据，表明难治性 OAB 患者受益于新型 SacralStim 系统。需要进一步研究以直接比较 SacralStim 系统与传统的四触点设备。
本研究证实了一种新型骶神经刺激系统（SacralStim）治疗膀胱过度活动症的有效性和安全性。该系统的电极有六个触点，植入后可提供更多的编程选项。
