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).
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.
European urology focus. 2022 May 04 [Epub ahead of print]
Limin Liao, Zhonghan Zhou, Guoqing Chen, Zhihui Xu, Banggao Huang, Tie Chong, Qi Chen, Zhongqing Wei, Baixin Shen, Zhong Chen, Qing Ling, Zhiliang Weng, Haihong Jiang, Benkang Shi, Yan Li, Yiming Wang
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. Electronic address: ., 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., Department of Urology, Zhejiang Provincial People's Hospital, Hangzhou, China., Department of Urology, Second Affiliated Hospital of Nanjing Medical University, Nanjing, China., Department of Urology, Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China., Department of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science Technology, Wuhan, China., Department of Urology, First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China., Department of Urology, Qilu Hospital of Shandong University, Jinan, China.