VIENNA—Botulinum toxin type A (BTA) injected into the prostate may be a safe and effective treatment for lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH), according to preliminary study results presented here at the 26th Annual Congress of the European Association of Urology.

Emilio Sacco, MD, and colleagues at Catholic University Medical School in Rome tested the treatment in men with BPH who had an unsatisfactory response to combined therapy with an alpha blocker and 5-alpha reductase inhibitor.

They randomly assigned 10 men to receive add-on intraprostatic BTA and 10 to receive saline injections (controls). The treatment group received 200-300 IU of BTA diluted in 6 mL of saline solution and injected into the transitional zone transperitoneally under transrectal ultrasound guidance. The researchers evaluated patients at baseline and at three months.

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The team observed no local or systemic adverse effects in any patient. At three months, prostate volume, postvoid residual urine volume, International Prostate Symptom Score (IPSS), and IPSS quality of life index were significantly reduced by a mean of 18.9% (from 59.5 to 48.3 cm3), 80.6% (from 97.7 to 18.3 mL), 55.3% (from 23.3 to 10.4), and 50% (from 4.7 to 2.4), respectively compared with controls. The maximum flow rate rose significantly by 68% (from 7.2 to 12.1 mL/sec).

Additionally, mean maximum cystometric capacity increased by a significant 40% from 273 to 380 mL) and mean bladder outlet obstruction index decreased by a significant 53.8% (from 52.7 to 24.1).

PSA values did not change significantly in either group.

Co-investigator Angelo Totaro, MD, who presented study results, said the findings show that intraprostatic BTA injections can improve urinary symptoms and quality of life in patients with symptomatic BPH and unsatisfactory response to combined medical therapy or those who refuse surgery or are poor surgical candidates.