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

Allergan

Status and phase: Completed; Phase 2

Conditions: Benign Prostatic Hyperplasia

Treatments: Drug: Normal saline; Drug: botulinum toxin Type A

Study type: Interventional

Funder types: Industry

Identifiers

NCT01107392

191622-100

Details and patient eligibility

About

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.

Enrollment: 315 patients

Sex: Male

Ages: 45+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical enlargement of the prostate gland
• Body weight ≥ 50 kg or 110 lbs

Exclusion criteria

• History of chronic prostatitis
• History of two or more urinary tract infections in the past year or one in the last 6 months
• History of bladder stones
• History of previous prostate surgery
• History of bladder cancer or prostate cancer
• Any previous or current usage of botulinum toxin therapy of any serotype for any urological condition
• Botulinum toxin therapy of any serotype for any non-urological condition or usage (e.g., cosmetic) during the previous 12 weeks prior to study entry

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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315 participants in 2 patient groups, including a placebo group

botulinum toxin Type A

Experimental group

Description:

botulinum toxin Type A total dose of 200U equally divided and administered to each lateral prostatic lobe.

Treatment:

Drug: botulinum toxin Type A

Placebo (Normal saline)

Placebo Comparator group

Description:

Placebo (Normal saline) equally divided and administered to each lateral prostatic lobe.

Treatment:

Drug: Normal saline