The safety and efficiency of onabotulinumtoxinA for the treatment of overactive bladder: a systematic review and meta-analysis.

PURPOSE: To assess the impact on safety and efficiency of onabotulinumtoxinA (BOTOX1, Allergan, Inc.) treatment in patients with an overactive bladder.

MATERIALS AND

METHODS

We searched the PubMed(®), Embase(®), and Cochrane Library Databases to identify all randomized controlled trials comparing the outcomes of onabotulinumtoxinA and placebo for overactive bladder. The outcomes included reductions in overactive bladder symptoms or improvements in the function of bladder and the side effects of two treatments. The Cochrane Collaboration Review Manager software (RevMan 5.1.4) was used for statistical analysis.

RESULTS

The study inclusion criteria were met by eight randomized controlled trials involving 1875 patients. The synthesized data from these randomized controlled trials indicated that onabotulinumtoxinA was better than placebo in decreasing most overactive bladder symptoms (p < 0.00001, p < 0.00001, p < 0.00001, p < 0.00001, p = 0.0003) in the micturition, urgency, urinary incontinence, urgency urinary incontinence (UUI), and nocturia per day change, respectively; however, the maximum cystometric capacity change from the baseline appeared not to be significantly different between two methods (p = 0.05). In addition, the side effects in the onabotulinumtoxinA group were more serious than the placebo group (p < 0.00001, p = 0.009, p = 0.07, p < 0.0001, p = 0.03 in the UTI, bacteriuria, dysuria, urinary retention, residual urine volume, respectively).

CONCLUSIONS

Compared with the placebo, onabotulinumtoxinA had significantly and clinically relevant reductions in overactive bladder symptoms, but it also leaded to more side effects.