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

Phase 2

Completed

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

• Registration Number: NCT01107392
• Lead Sponsor: Allergan

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-04-16
• Study First Submitted QC: 2010-04-19
• Study First Posted: 2010-04-21
• Study Start: 2010-08-01
• Primary Completion: 2012-03-16
• Study Completion: 2012-06-08
• Disposition First Submitted: 2013-03-14
• Disposition First Submitted QC: 2013-03-14
• Disposition First Posted: 2013-03-20
• Results First Submitted: 2014-02-24
• Results First Submitted QC: 2014-02-24
• Results First Posted: 2014-04-04
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-29
• Last Update Posted: 2019-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 315

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
botulinum toxin Type A	botulinum toxin Type A	botulinum toxin Type A total dose of 200U equally divided and administered to each lateral prostatic lobe.
Placebo (Normal saline)	Normal saline	Placebo (Normal saline) equally divided and administered to each lateral prostatic lobe.

Primary Outcome Measures

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

Name	Time	Method
Duration of Effect	24 Weeks	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.
Change From Baseline in Peak Urine Flow Rate	Baseline, Weeks 6, 12 and 24	Urinary flow was determined by uroflowmetry measured in milliliters/second (mL/sec). An increase from Baseline indicated improvement.
Change From Baseline in the Total International Prostate Symptom Score (IPSS)	Baseline, Week 6, Week 24	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.