Safety and Efficacy of Botulinum Toxin Type A to Treat Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia | NCT01107392 | Trialant
CompletedInterventionalPhase 2Updated May 3, 2019
Safety and Efficacy of Botulinum Toxin Type A to Treat Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia
ClinicalTrials.gov ID
NCT01107392
Lead Sponsor
AllerganINDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Phase 2
Enrollment
315Actual
Last Update Posted
May 3, 2019Actual
Start Date
Aug 1, 2010Actual
Primary Completion Date
Mar 16, 2012Actual
Completion Date
Jun 8, 2012Actual
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.
Benign Prostatic Hyperplasia
botulinum toxin Type A
Normal saline
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
Male
Accepts Healthy Volunteers
No
Eligibility 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