Relief by botulinum toxin of lower urinary tract symptoms owing to benign prostatic hyperplasia: early and long-term results.

Objectives: To present a comprehensive experience with intraprostatic botulinum toxin (BT) injection in men with symptomatic benign prostatic hyperplasia (BPH).

Methods: In this open-label study using an outpatient setting, 77 men with BPH received 200 intraprostatic BT A units (Botox) using an ultrasound-guided transperineal approach. We evaluated the American Urological Association (AUA) score, serum prostate-specific antigen (PSA), prostatic volume, residual volume, and peak urinary flow rates. The primary endpoint was symptomatic improvement after treatment, as measured by means of AUA score and peak urinary flow rates. The secondary endpoint was the evaluation of prostatic volume, serum PSA, and residual urinary volume.

Results: No significant local effects occurred. At their 1-month evaluation, 41 patients had subjective symptomatic relief. Compared with baseline values, AUA score was reduced from 24.1 +/- 4.6 to 12.6 +/- 2.9 (P = .00001), and serum PSA from 6.2 +/- 1.7 to 4.8 +/- 1.0 ng/mL (P = .03). At the same time, prostatic volume and residual urine volume were reduced by 12.7% and 12.8%, respectively, and mean peak urinary flow rate increased (P = .01). At 2 months' evaluation, 55 patients had subjective symptomatic relief. AUA score was reduced by 63.9% (P = .00001) compared with baseline values. In the same patients, serum PSA, prostatic volume, and residual urine volume were reduced by 51.6% (P = .00001), 42.8% (P = .00001), and 55.9% (P = .002), respectively, and mean peak urinary flow rate increased significantly.

Conclusions: Intraprostatic BT seems to be a promising approach to the treatment of BPH. It is safe, effective, well-tolerated, and not related to the patient's willingness to complete treatment.