PMID- 35250586 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20220308 IS - 1663-9812 (Print) IS - 1663-9812 (Electronic) IS - 1663-9812 (Linking) VI - 13 DP - 2022 TI - Hengli((R)) Chinese Botulinum Toxin Type A for Treatment of Patients With Overactive Bladder: A Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled Trial. PG - 840695 LID - 10.3389/fphar.2022.840695 [doi] LID - 840695 AB - Objective: To evaluate the efficacy and safety of Hengli((R)) Chinese botulinum toxin type A (BTX-A; 100 U) in Chinese patients with overactive bladder. Methods: This study was a multicenter, randomized, double-blind, placebo-controlled trial in Chinese patients who were inadequately managed with anticholinergic medications. Eligible patients were randomized 2:1 to receive intradetrusor injections of Hengli((R)) BTX-A (n = 144) or placebo (n = 72). The primary endpoint was the change in the number of daily micturition episodes at week 6 from baseline. The secondary efficacy endpoints included the average frequency of urgency and urinary incontinence (UI) episodes per day, urgency score, average micturition volume per day, OABSS, and QoL score. Results: In the Hengli((R)) BTX-A group, there was a significantly greater reduction in the average number of micturition episodes per 24 h compared with the placebo group (3.28 vs. 1.43; p = 0.003). Moreover, there was a significantly greater improvement in the daily number of urgency episodes, micturition volume and OABSS score. An increased post-void residual urine volume, dysuria, and urinary tract infection represented adverse events (AEs) in the Hengli((R)) BTX-A group. Most AEs were mild or moderate in severity. One patient in the BTX-A group initiated clean intermittent catheterization (CIC) during treatment. Conclusion: Hengli((R)) BTX-A treatment was well-tolerated and resulted in significant improvements in OAB symptoms among Chinese patients inadequately managed by anticholinergics. Clinical Trial Registration: http://www.chinadrugtrials.org.cn/clinicaltrials.prosearch.dhtml, Identifier: CTR20131190. CI - Copyright (c) 2022 Liao, Liu, Cong, Xu, Li, Weng, Jiang, Liu, Huang, Xia, Wen, Wu, Shi, Wang, Li, Yu, Fang, Zheng, Tian, Shang, Li, Huang, Zhou, Xiao, Zhang, Wang, Zhang, Zhang, Wang, Zhang, Xie, Wang, Ma, Tian, Chen and Dong. FAU - Liao, Limin AU - Liao L AD - Department of Urology, China Rehabilitation Research Center, School of Rehabilitation Medicine, Capital Medical University, Beijing, China. AD - Cheeloo College of Medicine, Shandong University, Jinan, China. AD - University of Health and Rehabilitation Sciences, Qingdao, China. FAU - Liu, Qinggang AU - Liu Q AD - Department of Urology, China Rehabilitation Research Center, School of Rehabilitation Medicine, Capital Medical University, Beijing, China. AD - Cheeloo College of Medicine, Shandong University, Jinan, China. AD - University of Health and Rehabilitation Sciences, Qingdao, China. FAU - Cong, Huiling AU - Cong H AD - Department of Urology, China Rehabilitation Research Center, School of Rehabilitation Medicine, Capital Medical University, Beijing, China. AD - Cheeloo College of Medicine, Shandong University, Jinan, China. FAU - Xu, Zhihui AU - Xu Z AD - Department of Urology, Zhejiang Provincial People's Hospital, Hangzhou, China. FAU - Li, Enhui AU - Li E AD - Department of Urology, Zhejiang Provincial People's Hospital, Hangzhou, 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 - Liu, Ben AU - Liu B AD - Department of Urology, First Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China. FAU - Huang, Xiao AU - Huang X AD - Department of Urology, First Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China. FAU - Xia, Shujie AU - Xia S AD - Department of Urology, Shanghai First People's Hospital, Shanghai, China. FAU - Wen, Wei AU - Wen W AD - Department of Urology, Shanghai First People's Hospital, Shanghai, China. FAU - Wu, Juan AU - Wu J AD - Department of Urology, China Rehabilitation Research Center, School of Rehabilitation Medicine, Capital Medical University, Beijing, China. AD - Cheeloo College of Medicine, Shandong University, Jinan, China. FAU - Shi, Guowei AU - Shi G AD - Department of Urology, Shanghai Fifth People's Hospital, Shanghai, China. FAU - Wang, Yang AU - Wang Y AD - Department of Urology, Shanghai Fifth People's Hospital, Shanghai, China. FAU - Li, Peijun AU - Li P AD - Department of Urology, Ningxia Medical University General Hospital, Xining, China. FAU - Yu, Yang AU - Yu Y AD - Department of Urology, Ningxia Medical University General Hospital, Xining, China. FAU - Fang, Zujun AU - Fang Z AD - Department of Urology, Huashan Hospital, Fudan University, Shanghai, China. FAU - Zheng, Jie AU - Zheng J AD - Department of Urology, Huashan Hospital, Fudan University, Shanghai, China. FAU - Tian, Ye AU - Tian Y AD - Department of Urology, Beijing Friendship Hospital, Capital Medical University, Beijing, China. FAU - Shang, Donghao AU - Shang D AD - Department of Urology, Beijing Friendship Hospital, Capital Medical University, Beijing, China. FAU - Li, Hanzhong AU - Li H AD - Department of Urology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, China. FAU - Huang, Zhongming AU - Huang Z AD - Department of Urology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, China. FAU - Zhou, Liqun AU - Zhou L AD - Department of Urology, Peking University First Hospital, Beijing, China. FAU - Xiao, Yunxiang AU - Xiao Y AD - Department of Urology, Peking University First Hospital, Beijing, China. FAU - Zhang, Yaoguang AU - Zhang Y AD - Department of Urology, Beijing Hospital, Beijing, China. FAU - Wang, Jianlong AU - Wang J AD - Department of Urology, Beijing Hospital, Beijing, China. FAU - Zhang, Xiaodong AU - Zhang X AD - Department of Urology, Beijing Chaoyang Hospital, Capital Medical University, Beijing, China. FAU - Zhang, Peng AU - Zhang P AD - Department of Urology, Beijing Chaoyang Hospital, Capital Medical University, Beijing, China. FAU - Wang, Dongwen AU - Wang D AD - Department of Urology, First Hospital of Shanxi Medical University, Taiyuan, China. FAU - Zhang, Xuhui AU - Zhang X AD - Department of Urology, First Hospital of Shanxi Medical University, Taiyuan, China. FAU - Xie, Keji AU - Xie K AD - Department of Urology, Guangzhou First People's Hospital, Guangzhou, China. FAU - Wang, Bin AU - Wang B AD - Department of Urology, Guangzhou First People's Hospital, Guangzhou, China. FAU - Ma, Lulin AU - Ma L AD - Department of Urology, Peking University Third Hospital, Beijing, China. FAU - Tian, Xiaojun AU - Tian X AD - Department of Urology, Peking University Third Hospital, Beijing, China. FAU - Chen, Lijun AU - Chen L AD - Department of Urology, Fifth Medical Center of PLA General Hospital, Beijing, China. FAU - Dong, Jinkai AU - Dong J AD - Department of Urology, Fifth Medical Center of PLA General Hospital, Beijing, China. LA - eng PT - Journal Article DEP - 20220218 PL - Switzerland TA - Front Pharmacol JT - Frontiers in pharmacology JID - 101548923 PMC - PMC8894806 OTO - NOTNLM OT - China OT - Hengli(R) OT - botulinum toxin type A OT - overactive bladder OT - randomized controlled trial COIS- The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. EDAT- 2022/03/08 06:00 MHDA- 2022/03/08 06:01 PMCR- 2022/02/18 CRDT- 2022/03/07 06:02 PHST- 2021/12/22 00:00 [received] PHST- 2022/02/01 00:00 [accepted] PHST- 2022/03/07 06:02 [entrez] PHST- 2022/03/08 06:00 [pubmed] PHST- 2022/03/08 06:01 [medline] PHST- 2022/02/18 00:00 [pmc-release] AID - 840695 [pii] AID - 10.3389/fphar.2022.840695 [doi] PST - epublish SO - Front Pharmacol. 2022 Feb 18;13:840695. doi: 10.3389/fphar.2022.840695. eCollection 2022.