Safety and Efficacy Study of Botulinum Toxin Type A to Treat Lower Urinary Symptoms Due to Benign Prostatic Hyperplasia
Overview
- Phase
- Phase 2
- Intervention
- botulinum toxin Type A
- Conditions
- Benign Prostatic Hyperplasia
- Sponsor
- Allergan
- Enrollment
- 380
- Primary Endpoint
- Change From Baseline in International Prostate Symptom Score (IPSS) at Week 12
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
The purpose of this study was to determine the safety and effectiveness of different doses of botulinum toxin Type A in treating lower urinary tract symptoms due to benign prostatic hyperplasia.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Lower urinary tract symptoms due to benign prostatic hyperplasia
- •Enlarged prostate volume by rectal ultrasound
Exclusion Criteria
- •Previous prostate surgery
- •Previous or current diagnosis of prostate cancer
- •Use of other medications for the treatment of prostatic hyperplasia
- •Urinary tract infection
Arms & Interventions
botulinum toxin Type A 100 U
Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.
Intervention: botulinum toxin Type A
botulinum toxin Type A 300 U
Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.
Intervention: botulinum toxin Type A
botulinum toxin Type A 200 U
Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.
Intervention: botulinum toxin Type A
Placebo (Normal Saline)
Placebo (Normal Saline) transperineal or transrectal injection on Day 1.
Intervention: normal saline
Outcomes
Primary Outcomes
Change From Baseline in International Prostate Symptom Score (IPSS) at Week 12
Time Frame: Baseline, Week 12
The International Prostate Symptom Score is a disease-specific outcome measure based on the American Urological Association Symptom Index. The questionnaire consists of seven items. The patient evaluates their urinary symptoms (incomplete emptying, frequency, hesitancy, urgency, weak stream, straining, and nocturia) during the previous 4 weeks. The total symptom score can range from 0 (no symptoms) to 35 (most severe symptoms). A negative change from baseline indicates improvement.
Secondary Outcomes
- Change From Baseline in International Prostate Symptom Score (IPSS) at Week 72(Baseline, Week 72)
- Change From Baseline in Peak Urine Flow Rate(Baseline, Week 12, Week 72)
- Change From Baseline in Total Prostate Volume(Baseline, Week 12, Week 72)
- Change From Baseline in Transitional Zone Prostate Volume(Baseline, Week 12, Week 72)
- Change From Baseline in Post-Void Residual(Baseline, Week 2, Week 12, Week 72)