PMID- 38468422
OWN - NLM
STAT- Publisher
LR  - 20240312
IS  - 1464-410X (Electronic)
IS  - 1464-4096 (Linking)
DP  - 2024 Mar 11
TI  - Efficacy and safety of tibial nerve stimulation using a wearable device for 
      overactive bladder.
LID - 10.1111/bju.16330 [doi]
AB  - OBJECTIVE: To evaluate the efficacy and safety of a wearable, 
      smartphone-controlled, rechargeable transcutaneous tibial nerve stimulation 
      (TTNS) device in patients with overactive bladder (OAB). PATIENTS AND METHODS: 
      This multicentre, prospective, single-blind, randomised clinical trial included 
      eligible patients with OAB symptoms who were randomly assigned to the stimulation 
      group or sham group. The primary efficacy outcome was change from baseline in 
      voiding frequency/24 h after 4 weeks of treatment. The secondary efficacy 
      outcomes included changes in bladder diary outcomes (urgency score/void, nocturia 
      episodes/day, micturition volume/void, and incontinence episodes/day), 
      questionnaires on Overactive Bladder Symptom Score (OABSS), Patient Perception of 
      Bladder Condition (PPBC), and American Urological Association Symptom Index 
      Quality of Life Score (AUA-SI-QoL) at baseline and after 4 weeks of treatment. 
      Device-related adverse events (AEs) were also evaluated. RESULTS: In the full 
      analysis set (FAS), the mean (sd) change of voiding frequency/24 h in the 
      stimulation group and sham group at 4 weeks were -3.5 (2.9) and -0.6 (2.4), 
      respectively (P < 0.01). Similar results were obtained in the per-protocol set 
      (PPS): -3.5 (2.9) vs -0.4 (2.3) (P < 0.01). In the FAS and PPS, micturition 
      volume/void significantly improved at 4 weeks (P = 0.01 and P = 0.02). PPBC 
      improvement almost reached significance in the FAS (P = 0.05), while it was 
      significant in the PPS (P = 0.02). In the FAS and PPS, AUA-SI-QoL significantly 
      improved at 4 weeks in the two groups (P < 0.01 and P < 0.01), whereas there were 
      no significant differences in urgency score/void, nocturia episodes/day or OABSS 
      between the groups. Also, no device-related serious AEs were reported. 
      CONCLUSIONS: The non-invasive neuromodulation technique using the novel 
      ambulatory TTNS device is effective and safe for treating OAB. Its convenience 
      and easy maintenance make it a new potential home-based treatment modality. 
      Future studies are warranted to confirm its longer-term efficacy.
CI  - (c) 2024 BJU International.
FAU - Liao, Limin
AU  - Liao L
AUID- ORCID: 0000-0002-7092-6576
AD  - Department of Urology, China Rehabilitation Research Centre, China Rehabilitation 
      Science Institute, Rehabilitation School of Capital Medical University, Beijing, 
      China.
AD  - University of Health and Rehabilitation Sciences, Qingdao, Shandong, China.
FAU - Li, Xing
AU  - Li X
AUID- ORCID: 0000-0002-9116-8700
AD  - Department of Urology, China Rehabilitation Research Centre, China Rehabilitation 
      Science Institute, Rehabilitation School of Capital Medical University, Beijing, 
      China.
FAU - Chong, Tie
AU  - Chong T
AUID- ORCID: 0000-0002-2035-6544
AD  - Department of Urology, Second Affifiliated Hospital of Xi'an Jiaotong University, 
      Xi'an, China.
FAU - Chen, Qi
AU  - Chen Q
AD  - Department of Urology, Second Affifiliated Hospital of Xi'an Jiaotong University, 
      Xi'an, 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 - Chen, Min
AU  - Chen M
AD  - Department of Urology, Union Hospital, Tongji Medical College, Huazhong 
      University of Science and Technology, Wuhan, China.
FAU - Li, Haoran
AU  - Li H
AD  - Department of Urology, Union Hospital, Tongji Medical College, Huazhong 
      University of Science and Technology, Wuhan, China.
FAU - Wei, Zhongqing
AU  - Wei Z
AD  - Department of Urology, Second Affifiliated Hospital of Nanjing Medical 
      University, Nanjing, China.
FAU - Shao, Yunpeng
AU  - Shao Y
AD  - Department of Urology, Second Affifiliated Hospital of Nanjing Medical 
      University, Nanjing, China.
FAU - Lu, Jianxin
AU  - Lu J
AD  - Department of Urology, Guang'anmen Hospital, China Academy of Chinese Medical 
      Sciences, Beijing, China.
FAU - Pang, Ran
AU  - Pang R
AD  - Department of Urology, Guang'anmen Hospital, China Academy of Chinese Medical 
      Sciences, Beijing, China.
FAU - Li, Xunhua
AU  - Li X
AD  - Department of Urology, China Rehabilitation Research Centre, China Rehabilitation 
      Science Institute, Rehabilitation School of Capital Medical University, Beijing, 
      China.
AD  - University of Health and Rehabilitation Sciences, Qingdao, Shandong, China.
FAU - Wang, Yiming
AU  - Wang Y
AD  - Department of Urology, China Rehabilitation Research Centre, China Rehabilitation 
      Science Institute, Rehabilitation School of Capital Medical University, Beijing, 
      China.
LA  - eng
GR  - 2022-1-6011/Capital's Funds for Health Improvement and Research/
GR  - 82170792/Natural Science Foundation of China/
GR  - 7222235/Beijing Municipal Natural Science Foundation/
GR  - 2023YFC3606003/National Key Research and Development Program/
PT  - Journal Article
DEP - 20240311
PL  - England
TA  - BJU Int
JT  - BJU international
JID - 100886721
SB  - IM
OTO - NOTNLM
OT  - neuromodulation
OT  - overactive bladder
OT  - tibial nerve stimulation
OT  - transcutaneous
OT  - wearable
EDAT- 2024/03/12 06:42
MHDA- 2024/03/12 06:42
CRDT- 2024/03/12 02:24
PHST- 2024/03/12 06:42 [medline]
PHST- 2024/03/12 06:42 [pubmed]
PHST- 2024/03/12 02:24 [entrez]
AID - 10.1111/bju.16330 [doi]
PST - aheadofprint
SO  - BJU Int. 2024 Mar 11. doi: 10.1111/bju.16330.