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

Study 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.

Conditions
-----------------
Benign Prostatic Hyperplasia

Intervention / Treatment
-----------------
* Drug: botulinum toxin Type A
* Drug: Normal saline


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 45 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: botulinum toxin Type A<br>botulinum toxin Type A total dose of 200U equally divided and administered to each lateral prostatic lobe. | Drug: botulinum toxin Type A<br>* botulinum toxin Type A total dose of 200U equally divided and administered to each lateral prostatic lobe.<br>* Other names: onabotulinumtoxinA;|
| Placebo Comparator: Placebo (Normal saline)<br>Placebo (Normal saline) equally divided and administered to each lateral prostatic lobe. | Drug: Normal saline<br>* Placebo (Normal saline) equally divided and administered to each lateral prostatic lobe.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in the Total International Prostate Symptom Score (IPSS) at 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. | Baseline, Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in the Total International Prostate Symptom Score (IPSS) | 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. | Baseline, Week 6, Week 24 | 
| Change From Baseline in Peak Urine Flow Rate | Urinary flow was determined by uroflowmetry measured in milliliters/second (mL/sec). An increase from Baseline indicated improvement. | Baseline, Weeks 6, 12 and 24 | 
| Duration of Effect | Duration of effect was calculated from the time of the first follow-up visit with a ≥ 4-point reduction from Baseline in IPSS to the next visit when the IPSS change from Baseline was < 4-points. | 24 Weeks |