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

Completed · Phase 2 · Has a placebo group

Conditions studied: Benign Prostatic Hyperplasia

In brief

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.

Key facts

Study ID

NCT01107392

Run by

Allergan

People needed

315

Starts

2010-08-01

Expected to finish

2012-06-08

Last updated by the study team

2019-05-03

Who can join

Age: 45 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Study site — Newport Beach, California, United States
• Study site — Surrey, British Columbia, Canada
• Study site — Prague, Czechia
• Study site — Paris, France
• Study site — Munich, Germany
• Study site — Manila, Philippines
• Study site — Poznan, Poland
• Study site — Seoul, South Korea

Full record on ClinicalTrials.gov

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