Safety and Efficacy Study of Botulinum Toxin Type A to Treat Lower Urinary Symptoms Due to Benign Prostatic Hyperplasia

• Change From Baseline in International Prostate Symptom Score (IPSS) at Week 72 [ Time Frame: Baseline, Week 72 ] [ Designated as safety issue: No ]
  The International Prostate Symptom Score is a disease-specific outcome measure based on the American Urological Association Symptom Index. The questionnaire consists of seven items. The patient evaluates their urinary symptoms (incomplete emptying, frequency, hesitancy, urgency, weak stream, straining, and nocturia) during the previous 4 weeks. The total symptom score can range from 0 (no symptoms) to 35 (most severe symptoms). A negative change from baseline indicates improvement.
• Change From Baseline in Peak Urine Flow Rate [ Time Frame: Baseline, Week 12, Week 72 ] [ Designated as safety issue: No ]
  Urinary flow was determined by uroflowmetry at baseline and various time-points during the study. An increase from baseline indicates improvement.
• Change From Baseline in Total Prostate Volume [ Time Frame: Baseline, Week 12, Week 72 ] [ Designated as safety issue: No ]
  Measurement of the prostate volume was performed via transrectal ultrasound at baseline and various time-points during the study. The prostate gland was scanned and the volume was calculated using the formula: Volume (mL) = length × width × height × 0.523. A negative change from baseline indicates improvement.
• Change From Baseline in Transitional Zone Prostate Volume [ Time Frame: Baseline, Week 12, Week 72 ] [ Designated as safety issue: No ]
  Measurement of the transitional zone prostate volume was performed via transrectal ultrasound at baseline and various time-points during the study. The prostate gland was scanned and the volume was calculated using the formula: Volume (mL) = length × width × height × 0.523. A negative change from baseline indicates improvement.
• Change From Baseline in Post-Void Residual [ Time Frame: Baseline, Week 2, Week 12, Week 72 ] [ Designated as safety issue: No ]
  Post-void residual urine volume was assessed by bladder scan or ultrasound on all participants at baseline and various time-points during the study. After voiding, any residual urine volume in the bladder was measured. A negative change from baseline indicates improvement.

The purpose of this study was to determine the safety and effectiveness of different doses of botulinum toxin Type A in treating lower urinary tract symptoms due to benign prostatic hyperplasia.

• Biological: botulinum toxin Type A
  Botulinum toxin Type A 300 U, 200 U or 100 U transperineal or transrectal injection on Day 1.
  Other Name: BOTOX®
• Drug: normal saline
  Normal Saline (Placebo) transperineal or transrectal injection on Day 1.

• Experimental: botulinum toxin Type A 300 U
  Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.
  Intervention: Biological: botulinum toxin Type A
• Experimental: botulinum toxin Type A 200 U
  Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.
  Intervention: Biological: botulinum toxin Type A
• Experimental: botulinum toxin Type A 100 U
  Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.
  Intervention: Biological: botulinum toxin Type A
• Placebo Comparator: Placebo (Normal Saline)
  Placebo (Normal Saline) transperineal or transrectal injection on Day 1.
  Intervention: Drug: normal saline

Inclusion Criteria:

• Lower urinary tract symptoms due to benign prostatic hyperplasia
• Enlarged prostate volume by rectal ultrasound

Exclusion Criteria:

• Previous prostate surgery
• Previous or current diagnosis of prostate cancer
• Use of other medications for the treatment of prostatic hyperplasia
• Urinary tract infection