Safety/Tolerability Study of Alcohol Injection for Treatment of BPH (Enlarged Prostate)

American Medical Systems150 enrolled

Overview

Multi-center, prospective randomized dosing and safety research study. A maximum of 150 men will be enrolled in the study. Qualifying patients will receive one of three possible doses of the study drug. Symptoms will be evaluated before treatment, and then 1-week, 1-month, 3-months, and 6-months following treatment.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Enrollment

150

Conditions

Prostate Disease BPH Benign Prostatic Hyperplasia Benign Prostatic Hypertrophy

Interventions

dehydrated alcoholDRUG

Eligibility

Sex: MALEMin age: 50 YearsMax age: 80 Years

Medical Language ↔ Plain English

Eligible patients are 50 to 80-year-old men who have experienced some or all of the following urinary symptoms for at least 6 months: * frequent or urgent need to urinate * difficulty starting their urinary stream * interruption of their urinary stream * feeling of incomplete emptying of bladder after urinating * interruption of sleep due to the urge to urinate Patients should have tried oral medication for their condition in the past, and be willing to discontinue any current BPH medications for a period of time before undergoing study treatment. They should be in good general health and have no previous surgery, or other procedure(s) intended to reduce prostate size.

Data from ClinicalTrials.gov

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