Reason for request
Minor clinical added value in the treatment of idiopathic overactive bladder in adults
BOTOX has Marketing Authorisation in adults in the treatment of idiopathic overactive bladder associated with symptoms including three episodes of urinary incontinence with urinary urgency in 3 days, number of urinations ≥8 in adults not adequately managed with anticholinergics (after 3 months of treatment) or intolerant to anticholinergic treatment and properly conducted physiotherapy.
After 12 weeks of treatment, its efficacy was demonstrated by comparison with placebo. Clinical data in men are very limited (12 % of men in the phase III studies).
It has not been assessed by comparison with mirabegron (BETMIGA). Its role in relation to functional neuromodulation has still to be determined.
In the absence of long-term clinical data, the duration of the therapeutic effect seems unpredictable and the number of reinjections needed to obtain an optimal therapeutic response has still to be established. The long-term safety profile (including the risk of urinary retention and/or urinary infections) is not known.
Clinical Added Value
BOTOX provides a minor improvement in actual benefit (level IV) in the treatment of overactive bladder in patients in whom drug and non-drug treatments have failed (behavioural treatments and rehabilitation of the perineum and the sphincter)