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

Allergan315 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

315

Conditions

Benign Prostatic Hyperplasia

Interventions

botulinum toxin Type ADRUG

botulinum toxin Type A total dose of 200U equally divided and administered to each lateral prostatic lobe.

Normal salineDRUG

Placebo (Normal saline) equally divided and administered to each lateral prostatic lobe.

Eligibility

Sex: MALEMin age: 45 Years

Medical Language ↔ Plain English

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

Locations (8)

Unnamed facility

Newport Beach, California, United States

Unnamed facility

Surrey, British Columbia, Canada

Unnamed facility

Prague, Czechia

Unnamed facility

Paris, France

Outcomes

Primary Outcomes

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.

Time frame: Baseline, Week 12

Secondary Outcomes

Change From Baseline in the Total International Prostate Symptom Score (IPSS)

Time frame: 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.

Time frame: 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.

Time frame: 24 Weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.