Safety and Efficacy of Botulinum Toxin Type A to Treat Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia
Overview
- Phase
- Phase 2
- Intervention
- botulinum toxin Type A
- Conditions
- Benign Prostatic Hyperplasia
- Sponsor
- Allergan
- Enrollment
- 315
- Primary Endpoint
- Change From Baseline in the Total International Prostate Symptom Score (IPSS) at Week 12
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
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
Arms & Interventions
botulinum toxin Type A
botulinum toxin Type A total dose of 200U equally divided and administered to each lateral prostatic lobe.
Intervention: botulinum toxin Type A
Placebo (Normal saline)
Placebo (Normal saline) equally divided and administered to each lateral prostatic lobe.
Intervention: Normal saline
Outcomes
Primary Outcomes
Change From Baseline in the Total International Prostate Symptom Score (IPSS) at Week 12
Time Frame: Baseline, Week 12
IPSS is a disease-specific outcome measure based on the American Urological Association Symptom Index. The questionnaire consisted of seven items. The patient evaluated their urinary symptoms (incomplete emptying, frequency, hesitancy, urgency, weak stream, straining, and nocturia) during the previous 4 weeks. The total symptom score ranged from 0 (no symptoms) to 35 (most severe symptoms). A negative change from Baseline indicated improvement.
Secondary Outcomes
- Duration of Effect(24 Weeks)
- Change From Baseline in Peak Urine Flow Rate(Baseline, Weeks 6, 12 and 24)
- Change From Baseline in the Total International Prostate Symptom Score (IPSS)(Baseline, Week 6, Week 24)