At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 315 enrolled
Drug / intervention
botulinum toxin Type A +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Safety and Efficacy of Botulinum Toxin Type A to Treat Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia
In Brief
A Phase 2 clinical trial evaluating botulinum toxin Type A and Normal saline for Benign Prostatic Hyperplasia. Completed, enrolled 315 participants across 8 sites in 8 countries.
Detailed 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 Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBenign Prostatic Hyperplasia
CountriesCanada, Czechia, France, Germany, Philippines, Poland, South Korea, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 2010
Enrollment StartAug 2010
Primary CompletionMar 2012
Study CompletionJun 2012
TodayJul 2026
First PostedApr 21, 2010
Enrollment StartAug 1, 2010
Primary CompletionMar 16, 2012
Study CompletionJun 8, 2012
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 16.2 years ago
Interventions
botulinum toxin Type Adrug
botulinum toxin Type A total dose of 200U equally divided and administered to each lateral prostatic lobe.
Normal salinedrug
Placebo (Normal saline) equally divided and administered to each lateral prostatic lobe.