In a nutshell
This study investigated the safety and effectiveness of onabotulinumtoxinA (Botox, or botulinum toxin) in patients with neurogenic detrusor overactivity (NDO). This study concluded that onabotulinumtoxinA is effective and safe for treating patients with NDO compared to placebo.
Some background
Neurogenic detrusor overactivity (NDO) refers to bladder dysfunction and overactive bladder (OAB) symptoms associated with nervous system diseases like multiple sclerosis (MS) or spinal cord injury.
OnabotulinumtoxinA injections are used to paralyze the bladder muscle in severe cases of OAB. Because it is delivered directly to the bladder via injection, the potential for systemic side effects is reduced. However, this treatment can lead to side effects like urine retention. Whether onabotulinumtoxinA can improve OAB symptoms in patients with NDO remains under investigation.
Methods & findings
This study involved a total of 1,382 patients from six trials comparing Botox treatment to a placebo (substance with no active effect). 65.1% of patients received onabotulinumtoxinA. Of these, 50.4% received 200 units (200U) and 49.6% received 300 units (300U). 34.9% of patients received a placebo injection. Follow-up was at 6 weeks after treatment.
At 6 weeks, the reductions in the average number of incontinence episodes per week decreased by 10.72 with 200U treatment dose, and by 11.42 with 300U treatment dose.
The maximum urine volume held until the urge to urinate (maximum cystometric capacity; MCC) also increased in Botox-treated patients compared to placebo. The average MCC values were 141.30 (200U) and 151.39 (300U). These differences were statistically significant. No significant difference was observed between the two Botox doses.
The maximum bladder pressure (detrusor pressure; MDP) also decreased in Botox-treated patients compared to placebo. The average MDP values decreased by 33.46 (200U) and 31.72 (300U). These differences were statistically significant. No significant difference was observed between the two Botox doses.
Five studies included in this analysis reported side effects. These included urinary tract infections (47% increased risk), urinary retention (5.58-fold increased risk), blood in the urine (70% increased risk), and muscle weakness (2.59-fold increased risk). Side effects were either transient or easily manageable.
The bottom line
This study concluded that onabotulinumtoxinA is effective and safe for treating patients with NDO. OnabotulinumtoxinA significantly reduced symptoms at 6 weeks after treatment.
The fine print
Data from approximately 1,382 patients across three studies out of a total 1,915 patients was included in the current study’s analysis. Also, side effects that occurred as a result of the injection procedure were not included in the analysis. This limited data collection may influence the conclusions that may be drawn from these results.
More research is needed to determine the optimum onabotulinumtoxinA doses and the effects of long-term injection regimens.
Published By :
PLOS ONE
Date :
Jul 27, 2016
