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).

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

doi:10.3390/toxins13120911

Abstract

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.

Highlights

Overactive bladder (OAB) is defined as urinary urgency, commonly accompanied by frequent urination and nocturia, with or without urgency urinary incontinence (UUI) and without urinary tract infection (UTI) or any pathological condition [1]
Key Contribution: The phase IV; pre/post; multi-center study showed that intradetrusor onabotulinumtoxinA injections were safe and improved subjective measures related to Neurogenic detrusor overactivity (NDO) or OAB during a 12-week follow-up in a real-world setting at Taiwan
Post-treatment, Patient Perception Bladder Condition (PPBC), four domains of Neurogenic Bladder Symptom Score (NBSS) and quality of life (QOL) were significantly improved at 4 weeks and 12 weeks compared with baseline (Table 2)

Summary

Introduction

Overactive bladder (OAB) is defined as urinary urgency, commonly accompanied by frequent urination and nocturia, with or without urgency urinary incontinence (UUI) and without urinary tract infection (UTI) or any pathological condition [1]. An epidemiological survey in Asia showed that 16.9~20.8% of the population over 40 years old had OAB, which reduced many patients’ quality of life (QOL) and increased their health care expenses [2,3]. Patients with NDO usually suffer from urine leaking during the storage phase because of decreased bladder capacity, decreased bladder compliance and increased intravesical pressure. These disease-associated changes can impact on the QOL and life expectancy of patients [4]. The primary treatment of OAB is behavioral modification or physical therapy, followed by oral medication (anti-muscarinic drugs and/or beta-3 adrenergic agonist) [5]. Oral medications fail to provide effective treatment and have poor long-term tolerance [6,7]

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