Frontiers in Pharmacology (Feb 2022)
Hengli® Chinese Botulinum Toxin Type A for Treatment of Patients With Overactive Bladder: A Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled Trial
- Limin Liao,
- Limin Liao,
- Limin Liao,
- Qinggang Liu,
- Qinggang Liu,
- Qinggang Liu,
- Huiling Cong,
- Huiling Cong,
- Zhihui Xu,
- Enhui Li,
- Zhiliang Weng,
- Haihong Jiang,
- Ben Liu,
- Xiao Huang,
- Shujie Xia,
- Wei Wen,
- Juan Wu,
- Juan Wu,
- Guowei Shi,
- Yang Wang,
- Peijun Li,
- Yang Yu,
- Zujun Fang,
- Jie Zheng,
- Ye Tian,
- Donghao Shang,
- Hanzhong Li,
- Zhongming Huang,
- Liqun Zhou,
- Yunxiang Xiao,
- Yaoguang Zhang,
- Jianlong Wang,
- Xiaodong Zhang,
- Peng Zhang,
- Dongwen Wang,
- Xuhui Zhang,
- Keji Xie,
- Bin Wang,
- Lulin Ma,
- Xiaojun Tian,
- Lijun Chen,
- Jinkai Dong
Affiliations
- Limin Liao
- Department of Urology, China Rehabilitation Research Center, School of Rehabilitation Medicine, Capital Medical University, Beijing, China
- Limin Liao
- Cheeloo College of Medicine, Shandong University, Jinan, China
- Limin Liao
- University of Health and Rehabilitation Sciences, Qingdao, China
- Qinggang Liu
- Department of Urology, China Rehabilitation Research Center, School of Rehabilitation Medicine, Capital Medical University, Beijing, China
- Qinggang Liu
- Cheeloo College of Medicine, Shandong University, Jinan, China
- Qinggang Liu
- University of Health and Rehabilitation Sciences, Qingdao, China
- Huiling Cong
- Department of Urology, China Rehabilitation Research Center, School of Rehabilitation Medicine, Capital Medical University, Beijing, China
- Huiling Cong
- Cheeloo College of Medicine, Shandong University, Jinan, China
- Zhihui Xu
- Department of Urology, Zhejiang Provincial People’s Hospital, Hangzhou, China
- Enhui Li
- Department of Urology, Zhejiang Provincial People’s Hospital, Hangzhou, China
- Zhiliang Weng
- Department of Urology, First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China
- Haihong Jiang
- Department of Urology, First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China
- Ben Liu
- Department of Urology, First Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China
- Xiao Huang
- Department of Urology, First Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China
- Shujie Xia
- Department of Urology, Shanghai First People’s Hospital, Shanghai, China
- Wei Wen
- Department of Urology, Shanghai First People’s Hospital, Shanghai, China
- Juan Wu
- Department of Urology, China Rehabilitation Research Center, School of Rehabilitation Medicine, Capital Medical University, Beijing, China
- Juan Wu
- Cheeloo College of Medicine, Shandong University, Jinan, China
- Guowei Shi
- Department of Urology, Shanghai Fifth People’s Hospital, Shanghai, China
- Yang Wang
- Department of Urology, Shanghai Fifth People’s Hospital, Shanghai, China
- Peijun Li
- Department of Urology, Ningxia Medical University General Hospital, Xining, China
- Yang Yu
- Department of Urology, Ningxia Medical University General Hospital, Xining, China
- Zujun Fang
- 0Department of Urology, Huashan Hospital, Fudan University, Shanghai, China
- Jie Zheng
- 0Department of Urology, Huashan Hospital, Fudan University, Shanghai, China
- Ye Tian
- 1Department of Urology, Beijing Friendship Hospital, Capital Medical University, Beijing, China
- Donghao Shang
- 1Department of Urology, Beijing Friendship Hospital, Capital Medical University, Beijing, China
- Hanzhong Li
- 2Department of Urology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, China
- Zhongming Huang
- 2Department of Urology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, China
- Liqun Zhou
- 3Department of Urology, Peking University First Hospital, Beijing, China
- Yunxiang Xiao
- 3Department of Urology, Peking University First Hospital, Beijing, China
- Yaoguang Zhang
- 4Department of Urology, Beijing Hospital, Beijing, China
- Jianlong Wang
- 4Department of Urology, Beijing Hospital, Beijing, China
- Xiaodong Zhang
- 5Department of Urology, Beijing Chaoyang Hospital, Capital Medical University, Beijing, China
- Peng Zhang
- 5Department of Urology, Beijing Chaoyang Hospital, Capital Medical University, Beijing, China
- Dongwen Wang
- 6Department of Urology, First Hospital of Shanxi Medical University, Taiyuan, China
- Xuhui Zhang
- 6Department of Urology, First Hospital of Shanxi Medical University, Taiyuan, China
- Keji Xie
- 7Department of Urology, Guangzhou First People’s Hospital, Guangzhou, China
- Bin Wang
- 7Department of Urology, Guangzhou First People’s Hospital, Guangzhou, China
- Lulin Ma
- 8Department of Urology, Peking University Third Hospital, Beijing, China
- Xiaojun Tian
- 8Department of Urology, Peking University Third Hospital, Beijing, China
- Lijun Chen
- 9Department of Urology, Fifth Medical Center of PLA General Hospital, Beijing, China
- Jinkai Dong
- 9Department of Urology, Fifth Medical Center of PLA General Hospital, Beijing, China
- DOI
- https://doi.org/10.3389/fphar.2022.840695
- Journal volume & issue
-
Vol. 13
Abstract
Objective: To evaluate the efficacy and safety of Hengli® 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® 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® 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® 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® 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.
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