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

実験的：botulinum toxin Type A 300 U

Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.

生物学的：botulinum toxin Type A

Botulinum toxin Type A 300 U, 200 U or 100 U transperineal or transrectal injection on Day 1.

他の名前：

• ボトックス®

実験的：botulinum toxin Type A 200 U

Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.

生物学的：botulinum toxin Type A

Botulinum toxin Type A 300 U, 200 U or 100 U transperineal or transrectal injection on Day 1.

他の名前：

• ボトックス®

実験的：botulinum toxin Type A 100 U

Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.

生物学的：botulinum toxin Type A

Botulinum toxin Type A 300 U, 200 U or 100 U transperineal or transrectal injection on Day 1.

他の名前：

• ボトックス®

プラセボコンパレーター：Placebo (Normal Saline)

Placebo (Normal Saline) transperineal or transrectal injection on Day 1.

薬：normal saline

Normal Saline (Placebo) transperineal or transrectal injection on Day 1.

Change From Baseline in International Prostate Symptom Score (IPSS) at Week 12

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 International Prostate Symptom Score (IPSS) at Week 72

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

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

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

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

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.

Change From Baseline in the International Index of Erectile Function (IIEF) Questionnaire Erectile Function Domain

The IIEF is a 15-item questionnaire filled out by the patient to assess erectile function over the past 4 weeks that contains five domains. The score for the erectile function domain is the sum of scores for Questions 1, 2, 3, 4, 5 and 15 for a total possible score of 1 to 30. A higher score indicates a better outcome. A positive change from baseline indicates improvement.