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Botulinum Toxin Helpful in Symptomatic BPH

Botulinum Toxin Helpful in Symptomatic BPH

NEW YORK (Reuters Health) Aug 08 – Onabotulinum toxin A is effective in treating lower urinary tract symptoms in men with benign prostatic hyperplasia (BPH), researchers report.

Last week executives at Allergan, which markets onabotulinum toxin A as Botox, told Reuters they expect U.S. regulators this year to approve Botox for overactive bladder caused by multiple sclerosis and spinal cord injury. Eventually Allergan hopes to win approval to market it to people with nocturia.

For the current study, Dr. Reginald Bruskewitz of the University of Wisconsin in Madison and colleagues randomized 134 men to prostatic transrectal injection of 100 or 300 units. Outcome was assessed at three months in 131 men and at 12 months in 108. Some withdrew, but others were excluded because they had other treatments during follow-up.

In the lower dose group, the mean American Urological Association symptom index was 18.8 at baseline, 11.7 at three months, and 11.9 at 12 months.

The higher dose group had a mean index of 19.5 at baseline, 10.6 at three months, and 12.4 at 12 months, according to a July 24th online report in the Journal of Urology.

The mean maximum urinary flow at baseline was 10 mL/sec in the low-dose group, 12.5 mL/sec at three months, and 12.2 mL/sec at one year. The baseline flow was 9.6 mL/sec in the high-dose group, rising to 12.2 at three months and dropping back to 11.9 at one year.

Serious adverse events developed in seven low-dose patients (10%) and five high-dose patients (8%) Only three complications, all of which were urosepsis, were judged by the authors to be related to the injection.

Although both doses showed treatment efficacy and safety, the investigators caution that "There is a substantial placebo effect in the medical treatment of BPH which may be exaggerated by injection therapy."

Thus they call for "a randomized clinical trial with the 100 unit or 300 unit dose compared to placebo."

The researchers report financial interests with Allergan and other companies.