Efficacy and safety of onabotulinumtoxinA intravesical injection with idiopathic overactive bladder patients in real clinical practice
Dr Hye Jin Byun (1), Joongwon Choi (1), Kwang Jin Ko2, Kyu-Sung Lee (1)
(1) Samsung Medical Center, Seoul, South Korea, (2)Kangnam Sacred Heart Hospital, Seoul, South Korea
The safety and efficacy of onabotulinumtoxinA can be confirmed through large clinical trials, however, a few results are available. Thus, the aim of this study is to determine the safety and efficacy of onabotulinumtoxinA for patients with overactive bladder (OAB) in real clinical practice.
This is a retrospective study conducted at single center from December 2012 to January 2019. Patients received onabotulinumtoxinA 100U due to idiopathic OAB who had an inadequate response to or were intolerant of anticholinergics were analyzed. Efficacy was assessed using the Overactive Bladder Symptom Score (OABSS) and 3-day voiding diary parameters that was completed before and 1-4 months after treatment. Safety was assessed throughout the follow-up period. And we also evaluated the ratio of re-treatment and time to interval between treatment.
Overall, 226 patients were included. The mean age was 62.1 years, and the ratio of female patients was 63.4 %. After treatment, total OABSS, OABSS urgency sub-score (Q3) were decreased from 10.2 to 7.5 (p<0.001), from 4.0 to 2.9 (p<0.001), respectively. Mean number of micturition was decreased from 13.5 to 10.8 times (p<0.001). Maximum flow rate (15.0 to 13.4 ml/s, p=0.054) and voided volume (147.6 to 138.1 cc, p=0.317) were not significantly changed. However, the post-residual urine was increased from 31 to 103 ml (p<0.001). The most frequently reported adverse event was acute urinary retention 5.3% (12/226) and these patients initiated de novo clean intermittent catheterization (CIC). Dysuria and gross hematuria occurred in 3 patients (1.2%) each. 41.5% (94/226) of patients received 2 or more onabotulinumtoxinA administration at median 12 months, and the mean number of treatment was 2.76 times.
OnabotulinumtoxinA 100U significantly improved OAB symptoms and was well tolerated in patients who were inadequately treated with anticholinergics in real clinical practice.