[Idiopathic overactive bladder and BOTOX(®): Literature review]

Systematically review literature on the efficacy and tolerability of botulinum toxin A (onabotulinumtoxineA, BOTOX(®), Allergan, CA, USA) in refractory idiopathic overactive bladder (iOAB) METHODS: Pubmed search on the efficacy, toxicity and adverse events of onabotulinumtoxinA in clinical trials only with level 1 and 2 evidence.

Eleven controlled randomised trials have been selected, of which 3 phase III trials. The studies published data of 1008 patients with refractory iOAB treated with onabotulinumtoxineA. In the phase II and III trials, doses from 50 U to 300 U have been evaluated; more than half of the patients (n = 676) with 100 U. In the 2 main phase III trials, onabotulinumtoxinA has demonstrated to be more efficient compared to placebo on continence, symptoms and quality of live (QoL). Urodynamic results, reported in the phase II trials, demonstrated higher changes compared to placebo only from dose 100 U on, although not always significant. Adverse events (urinary retention, dysuria, urinary tract infection) were easily treated and did not influence patient's QoL.

Intradetrusor injections of onabotulinumtoxinA (BOTOX(®)), a minimally-invasive procedure, seem to be efficient and well tolerated in the treatment of refractory iOAB.