Conditions: Benign Prostatic Hyperplasia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 380
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1. arm 2: Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1. arm 3: Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1. arm 4: Placebo (Normal Saline) transperineal or transrectal injection on Day 1.

Interventions: intervention 1: botulinum toxin Type A intervention 2: normal saline
Intervention descriptions: intervention 1: Botulinum toxin Type A 300 U, 200 U or 100 U transperineal or transrectal injection on Day 1. intervention 2: Normal Saline (Placebo) transperineal or transrectal injection on Day 1.

Protocol document: