Botulinum Neurotoxin Type A for the Treatment of Benign Prostatic Hyperplasia: Randomized Study Comparing Two Doses

René Arnouk,Roberto Benatuil Stull,Carlos Henrique Suzuki Bellucci,Cristiano Mendes Gomes,José De Bessa Junior,Cesar Augusto Malave

doi:10.1100/2012/463574

Abstract

Purpose. To assess the efficacy and safety of intraprostatic injection of two botulinum neurotoxin type A (BoNT-A) doses for the treatment of benign prostatic hyperplasia (BPH). Materials and Methods. Men with symptomatic BPH who failed medical treatment were randomized to receive 100 U or 200 U of BoNT-A into the prostate. The International Prostatic Symptom Score (IPSS), maximum flow rate (Qmax), post-void residual volume (PVR), PSA levels and prostate volume before injection and after 3 and 6 months were evaluated. Adverse events were compared between the groups. Results. Thirty four patients were evaluated, including 17 in the BoNT-A 100 U group and 17 in the BoNT-A 200 U group. Baseline characteristics were similar in both groups. Both doses produced significant improvements in IPSS, Qmax and PVR after 3 and 6 months and both doses promoted comparable effects. Prostate volume was affected by 200 U BoNT-A injection only after 6 months of treatment. PSA levels were significantly affected in the 100 U group only after 6 months of treatment. In the 200 U group, PSA levels were significantly decreased after 3 and 6 months. The complication rate was similar in both groups. Conclusions. Efficacy and safety of both BoNT-A doses are similar for BPH treatment in the short term followup.

Highlights

Benign prostatic hyperplasia (BPH) is a nonmalignant enlargement of the prostate that affects men in the adulthood [1]
Over a period of 2 years, men with symptomatic BPH were invited to participate in this prospective study
Two patients that failed to return for the follow-up evaluations were excluded

Summary

Introduction

Benign prostatic hyperplasia (BPH) is a nonmalignant enlargement of the prostate that affects men in the adulthood [1]. Pharmacological therapy, including 5αreductase inhibitors and alpha-adrenergic antagonists, is the most common treatment for BPH [2, 5,6,7,8]. Improvement of symptoms is often insufficient and the impact on the urinary flow is limited. Side effects such as dizziness, asthenia, postural hypotension, decreased libido, and erectile dysfunction can limit its use [2, 4]. Despite their high success rates, their invasiveness and potential side effects such as bleeding, retrograde ejaculation, urethral stenosis, urinary incontinence, and erectile dysfunction may be discouraging [4, 6, 9]. 15–25% of the patients who undergo surgery do not have satisfactory long-term outcomes [9] and reoperation is necessary in about 1% annually [6]

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