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

• Status: Completed
• Trial end date: 2012-06-08
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Allergan
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

Criteria

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