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Opinions on drugs - Posted on Jan 20 2015

Reason for request

Extension of indication

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 Benefit



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)