Effectiveness and Safety of Intradetrusor OnabotulinumtoxinA Injection for Neurogenic Detrusor Overactivity and Overactive Bladder Patients in Taiwan-A Phase IV Prospective, Interventional, Multiple-Center Study (Restore Study).

We conducted a phase IV, pre/post multi-center study to evaluate the efficacy and safety of intradetrusor onabotulinumtoxinA injection in patients with neurogenic detrusor overactivity (NDO, n = 119) or overactive bladder (OAB, n = 215). Patients received either 200U (i.e., NDO) and 100U (i.e., OAB) of onabotulinumtoxinA injection into the bladder, respectively. The primary endpoint for all patients was the change in the PPBC questionnaire score at week 4 and week 12 post-treatment compared with baseline. The secondary endpoints were the changes in subjective measures (i.e., questionnaires: NBSS for patients with NDO and OABSS for those with OAB) at week 4 and week 12 post-treatment compared with baseline. Adverse events included symptomatic UTI, de novo AUR, gross hematuria and PVR > 350mL were recorded. The results showed that compared with baseline, PPBC (3.4 versus 2.4 and 2.1, p < 0.001) and NBSS (35.4 versus 20.4 and 18.1, p < 0.001) were significantly improved at 4 weeks and 12 weeks in NDO patients. In addition, compared with baseline, PPBC (3.5 versus 2.3 and 2.0, p < 0.001) and OABSS (9.1 versus 6.2 and 5.7, p < 0.001) were significantly improved at 4 weeks and 12 weeks in OAB patients. Eight (6.7%) had symptomatic UTI and 5 (4.2%) had de novo AUR in NDO patients. Twenty (9.3%) had symptomatic UTI but no de novo AUR in OAB patients. In conclusion, we found that intradetrusor onabotulinumtoxinA injections were safe and improved subjective measures related to NDO or OAB in our cohort.

Toxins. 2021 Dec 20*** epublish ***

Chung-Cheng Wang, Eric Chieh-Lung Chou, Yao-Chi Chuang, Chih-Chieh Lin, Yu-Chao Hsu, Chun-Hou Liao, Hann-Chorng Kuo

Department of Urology, En Chu Kong Hospital, New Taipei City 237414, Taiwan., Department of Urology, China Medical University Hospital, School of Medicine, China Medical University, Taichung 406040, Taiwan., Department of Urology, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung 833401, Taiwan., Shu-Tien Urological Research Center, Department of Urology, Taipei Veterans General Hospital, School of Medicine, College of Medicine, National Yang Ming Chiao Tung University, Taipei 112304, Taiwan., Department of Urology, Linko Chang Gung Memorial Hospital, College of Medicine, Chang Gung University, Taoyung 333323, Taiwan., Department of Urology, Cardinal Tien Hospital, School of Medicine, Fu-Jen Catholic University, New Taipei City 242062, Taiwan., Department of Urology, Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Buddhist Tzu Chi University, Hualiang 970374, Taiwan.

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