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

Study Identifier
191622-100
CT.gov Identifier
NCT01107392
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Study Details

Medical Condition
  • Men's Health
    • Study Drug
  • botulinum toxin Type A
  • Normal saline
    • Phase
    Phase 2
    Sex
    Male
    Age
    45+ years
    Inclusion and Exclusion 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

    Protocol 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.

    Study Locations

    Location
    Status
    Location
    Newport Beach, California, United States
    Status
    Not applicable
    Location
    Surrey, British Columbia, Canada
    Status
    Not applicable
    Location
    Prague, Czech Republic
    Status
    Not applicable
    Location
    Paris, France
    Status
    Not applicable
    Location
    Munich, Germany
    Status
    Not applicable
    Location
    Manila, Philippines
    Status
    Not applicable
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