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

Study Overview
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Brief Summary
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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.

Conditions
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Benign Prostatic Hyperplasia

Intervention / Treatment
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* Biological: botulinum toxin Type A
* Drug: normal saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: botulinum toxin Type A 300 U<br>Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1. | Biological: botulinum toxin Type A<br>* Botulinum toxin Type A 300 U, 200 U or 100 U transperineal or transrectal injection on Day 1.<br>* Other names: BOTOX®;|
| Experimental: botulinum toxin Type A 200 U<br>Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1. | Biological: botulinum toxin Type A<br>* Botulinum toxin Type A 300 U, 200 U or 100 U transperineal or transrectal injection on Day 1.<br>* Other names: BOTOX®;|
| Experimental: botulinum toxin Type A 100 U<br>Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1. | Biological: botulinum toxin Type A<br>* Botulinum toxin Type A 300 U, 200 U or 100 U transperineal or transrectal injection on Day 1.<br>* Other names: BOTOX®;|
| Placebo Comparator: Placebo (Normal Saline)<br>Placebo (Normal Saline) transperineal or transrectal injection on Day 1. | Drug: normal saline<br>* Normal Saline (Placebo) transperineal or transrectal injection on Day 1.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in International Prostate Symptom Score (IPSS) at Week 72 | 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. | Baseline, Week 72 | 
| Change From Baseline in Peak Urine Flow Rate | Urinary flow was determined by uroflowmetry at baseline and various time-points during the study. An increase from baseline indicates improvement. | Baseline, Week 12, Week 72 | 
| Change From Baseline in Total Prostate Volume | Measurement of the prostate volume was performed via transrectal ultrasound at baseline and various time-points during the study. The prostate gland was scanned and the volume was calculated using the formula: Volume (mL) = length × width × height × 0.523. A negative change from baseline indicates improvement. | Baseline, Week 12, Week 72 | 
| Change From Baseline in Transitional Zone Prostate Volume | Measurement of the transitional zone prostate volume was performed via transrectal ultrasound at baseline and various time-points during the study. The prostate gland was scanned and the volume was calculated using the formula: Volume (mL) = length × width × height × 0.523. A negative change from baseline indicates improvement. | Baseline, Week 12, Week 72 | 
| Change From Baseline in Post-Void Residual | Post-void residual urine volume was assessed by bladder scan or ultrasound on all participants at baseline and various time-points during the study. After voiding, any residual urine volume in the bladder was measured. A negative change from baseline indicates improvement. | Baseline, Week 2, Week 12, Week 72 |