PMID- 35525837
OWN - NLM
STAT- MEDLINE
DCOM- 20221222
LR  - 20230124
IS  - 2405-4569 (Electronic)
IS  - 2405-4569 (Linking)
VI  - 8
IP  - 6
DP  - 2022 Nov
TI  - Sacral Neuromodulation Using a Novel Device with a Six-contact-point Electrode 
      for the Treatment of Patients with Refractory Overactive Bladder: A Multicenter, 
      Randomized, Single-blind, Parallel-control Clinical Trial.
PG  - 1823-1830
LID - S2405-4569(22)00083-9 [pii]
LID - 10.1016/j.euf.2022.04.006 [doi]
AB  - 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.
CI  - Copyright (c) 2022 European Association of Urology. Published by Elsevier B.V. All 
      rights reserved.
FAU - Liao, Limin
AU  - Liao L
AD  - 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: 
      lmliao@263.net.
FAU - Zhou, Zhonghan
AU  - Zhou Z
AD  - 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.
FAU - Chen, Guoqing
AU  - Chen G
AD  - 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.
FAU - Xu, Zhihui
AU  - Xu Z
AD  - Department of Urology, Zhejiang Provincial People's Hospital, Hangzhou, China.
FAU - Huang, Banggao
AU  - Huang B
AD  - Department of Urology, Zhejiang Provincial People's Hospital, Hangzhou, China.
FAU - Chong, Tie
AU  - Chong T
AD  - Department of Urology, Second Affiliated Hospital of Nanjing Medical University, 
      Nanjing, China.
FAU - Chen, Qi
AU  - Chen Q
AD  - Department of Urology, Second Affiliated Hospital of Nanjing Medical University, 
      Nanjing, China.
FAU - Wei, Zhongqing
AU  - Wei Z
AD  - Department of Urology, Second Affiliated Hospital of Xi'an Jiaotong University, 
      Xi'an, China.
FAU - Shen, Baixin
AU  - Shen B
AD  - Department of Urology, Second Affiliated Hospital of Xi'an Jiaotong University, 
      Xi'an, China.
FAU - Chen, Zhong
AU  - Chen Z
AD  - Department of Urology, Tongji Hospital, Tongji Medical College, Huazhong 
      University of Science Technology, Wuhan, China.
FAU - Ling, Qing
AU  - Ling Q
AD  - Department of Urology, Tongji Hospital, Tongji Medical College, Huazhong 
      University of Science Technology, Wuhan, China.
FAU - Weng, Zhiliang
AU  - Weng Z
AD  - Department of Urology, First Affiliated Hospital of Wenzhou Medical University, 
      Wenzhou, China.
FAU - Jiang, Haihong
AU  - Jiang H
AD  - Department of Urology, First Affiliated Hospital of Wenzhou Medical University, 
      Wenzhou, China.
FAU - Shi, Benkang
AU  - Shi B
AD  - Department of Urology, Qilu Hospital of Shandong University, Jinan, China.
FAU - Li, Yan
AU  - Li Y
AD  - Department of Urology, Qilu Hospital of Shandong University, Jinan, China.
FAU - Wang, Yiming
AU  - Wang Y
AD  - 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.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20220504
PL  - Netherlands
TA  - Eur Urol Focus
JT  - European urology focus
JID - 101665661
SB  - IM
MH  - Humans
MH  - Quality of Life
MH  - Single-Blind Method
MH  - *Urinary Bladder, Overactive/therapy
OTO - NOTNLM
OT  - Overactive bladder
OT  - Randomized controlled trial
OT  - Sacral neuromodulation
OT  - SacralStim system
OT  - Six-contact electrode
EDAT- 2022/05/08 06:00
MHDA- 2022/12/15 06:00
CRDT- 2022/05/07 22:14
PHST- 2021/12/25 00:00 [received]
PHST- 2022/02/27 00:00 [revised]
PHST- 2022/04/12 00:00 [accepted]
PHST- 2022/05/08 06:00 [pubmed]
PHST- 2022/12/15 06:00 [medline]
PHST- 2022/05/07 22:14 [entrez]
AID - S2405-4569(22)00083-9 [pii]
AID - 10.1016/j.euf.2022.04.006 [doi]
PST - ppublish
SO  - Eur Urol Focus. 2022 Nov;8(6):1823-1830. doi: 10.1016/j.euf.2022.04.006. Epub 
      2022 May 4.