Conditions: Benign Prostatic Hyperplasia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 315
Healthy volunteers: no

Brief summary:
This study will evaluate the safety and efficacy of intraprostatic administration of botulinum toxin Type A (BOTOX®) compared with placebo to treat urinary tract symptoms due to benign prostatic hyperplasia.

Detailed description:

Arms:
arm 1: botulinum toxin Type A total dose of 200U equally divided and administered to each lateral prostatic lobe. arm 2: Placebo (Normal saline) equally divided and administered to each lateral prostatic lobe.

Interventions: intervention 1: botulinum toxin Type A intervention 2: Normal saline
Intervention descriptions: intervention 1: botulinum toxin Type A total dose of 200U equally divided and administered to each lateral prostatic lobe. intervention 2: Placebo (Normal saline) equally divided and administered to each lateral prostatic lobe.

Protocol document: