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

Phase 2

Completed

• Conditions: Benign Prostatic Hyperplasia
• Interventions: Biological: botulinum toxin Type A; Drug: normal saline

• Registration Number: NCT00284518
• Lead Sponsor: Allergan

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12
• Study First Submitted: 2006-01-31
• Study First Submitted QC: 2006-01-31
• Study First Posted: 2006-02-01
• Primary Completion: 2009-05
• Disposition First Submitted: 2010-02-03
• Disposition First Submitted QC: 2010-02-03
• Disposition First Posted: 2010-02-08
• Study Completion: 2010-05
• Status Verified: 2012-11
• Results First Submitted: 2012-11-16
• Results First Submitted QC: 2012-11-16
• Last Update Submitted: 2012-11-16
• Results First Posted: 2012-12-17
• Last Update Posted: 2012-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 380

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
botulinum toxin Type A 300 U	botulinum toxin Type A	Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.
botulinum toxin Type A 200 U	botulinum toxin Type A	Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.
botulinum toxin Type A 100 U	botulinum toxin Type A	Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.
Placebo (Normal Saline)	normal saline	Placebo (Normal Saline) transperineal or transrectal injection on Day 1.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in International Prostate Symptom Score (IPSS) at Week 12	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 Outcome Measures

Name	Time	Method
Change From Baseline in International Prostate Symptom Score (IPSS) at Week 72	Baseline, 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.
Change From Baseline in Peak Urine Flow Rate	Baseline, Week 12, Week 72	Urinary flow was determined by uroflowmetry at baseline and various time-points during the study. An increase from baseline indicates improvement.
Change From Baseline in Total Prostate Volume	Baseline, Week 12, Week 72	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.
Change From Baseline in Transitional Zone Prostate Volume	Baseline, Week 12, Week 72	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.
Change From Baseline in Post-Void Residual	Baseline, Week 2, Week 12, Week 72	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.