NEW YORK (Reuters Health) - Injection of botulinum toxin (Botox) into the prostate appears to be a safe and effective treatment for voiding dysfunction due to benign prostatic hyperplasia (BPH), Italian investigators report.

Currently, Botox is approved by the US Food and Drug Administration for cosmetic applications. However, in a recent animal study, researchers showed that Botox injection into the prostate can induce atrophy of the gland, suggesting that it could also be a useful treatment for BPH.

In the current study, Dr. Giorgio Maria, from the University Hospital Agostino Gemelli in Rome, and colleagues assessed the voiding outcomes of 30 men with BPH-related voiding dysfunction who were randomized to receive Botox or saline injections. The average follow-up period was 19.6 months.

The new findings are published in the August issue of Urology.

At 2-month follow-up, 13 Botox-treated patients had experienced subjective symptom relief, compared with only 3 control subjects (p = 0.0007). Moreover, Botox treatment was tied to a 65% drop in symptom scores and a 51% fall in PSA levels. In contrast, neither of these parameters changed significantly with saline injection.

No local complications or systemic adverse effects were seen with either treatment, the investigators point out.

"We found Botox injection into the prostate to be a promising approach to the treatment of BPH," the authors state. "It is well-tolerated and should be considered for patients who are at risk of surgery."

However, in a related editorial, Dr. Alexis E. Te, from Weill Cornell Medical College in New York, cautions that, at present, Botox's "application in the urinary tract is clearly investigational."

"It should be strongly emphasized that cautious examination of its application in the general community is warranted because it is still a neurotoxin with potential and significant life-threatening morbidities," Dr. Te notes.

Urology 2003;62:259-265.

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