Phase 2 N=315 Randomized Double-blind Treatment

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

Benign Prostatic Hyperplasia

Bottom Line

View on ClinicalTrials.gov: NCT01107392 ↗

Enrolled (actual)

315

Serious AEs

4.1%

Results posted

Apr 2014

Primary outcome: Primary: Change From Baseline in the Total International Prostate Symptom Score (IPSS) at Week 12 — 21.8; 21.5; -6.3; -5.6 Score on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: botulinum toxin Type A (Drug); Normal saline (Drug)
Age: Adult, Older Adult · 45+ yrs
Sex: Male
Sponsor: Allergan
Primary completion: Mar 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in the Total International Prostate Symptom Score (IPSS) at Week 12	21.8; 21.5; -6.3; -5.6	—
SECONDARY Change From Baseline in the Total International Prostate Symptom Score (IPSS)	21.8; 21.5; -5.4; -5.3; -6.3; -6.0	—
SECONDARY Change From Baseline in Peak Urine Flow Rate	8.0; 8.0; 2.5; 1.2; 2.5; 1.7	—
SECONDARY Duration of Effect	20.9; 20.6	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01107392). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.