Relief by botulinum toxin of voiding dysfunction due to benign prostatic hyperplasia: results of a randomized, placebo-controlled study.
OBJECTIVE
To evaluate the therapeutic role of botulinum toxin injection in men with benign prostatic hyperplasia.


METHODS
Men with benign prostatic hyperplasia were enrolled in a randomized, placebo-controlled study. After a baseline evaluation, each participant received 4 mL of solution injected into the prostate gland. Patients in the control group received saline solution and patients in the treated group received 200 U of botulinum toxin A. The outcome of each group was evaluated by comparing the symptom scores, serum prostate-specific antigen concentration, prostate volume, postvoid residual urine volume, and peak urinary flow rates.


RESULTS
Thirty consecutive patients were enrolled. No local complications or systemic side effects were observed in any patient. After 2 months, 13 patients in the treated group and 3 in the control group had subjective symptomatic relief (P = 0.0007). In patients who received botulinum toxin, the symptom score was reduced by 65% compared with baseline values and the serum prostate-specific antigen concentration by 51% from baseline. In patients who received saline, the symptom score and serum prostate-specific antigen concentration were not significantly changed compared with the baseline values and 1-month values. Follow-up averaged 19.6 +/- 3.8 months.


CONCLUSIONS
Botulinum toxin injected into the prostate seems to be a promising approach for the treatment of benign prostatic hyperplasia. It is safe, effective, and well-tolerated. Furthermore, it is not related to the patient's willingness to complete treatment.
Maria
Giorgio
G
Department of Surgery, Catholic School of Medicine, University Hospital Agostino Gemelli, Rome, Italy.
Brisinda
Giuseppe
G
Civello
Ignazio Massimo
IM
Bentivoglio
Anna Rita
AR
Sganga
Gabriele
G
Albanese
Alberto
A
D000368:Aged; D000369:Aged, 80 and over; D001905:Botulinum Toxins / Q000008:administration & dosage / Q000627:therapeutic use*; D004311:Double-Blind Method; D006801:Humans; D015552:Injections, Intralesional; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D011446:Prospective Studies; D017430:Prostate-Specific Antigen / Q000097:blood; D011470:Prostatic Hyperplasia / Q000097:blood / Q000150:complications* / Q000188:drug therapy*; D012720:Severity of Illness Index; D014555:Urination Disorders / Q000097:blood / Q000188:drug therapy* / Q000209:etiology*; D014563:Urodynamics / Q000187:drug effects
D017430:Prostate-Specific Antigen; D001905:Botulinum Toxins