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

American Medical Systems

Status and phase: Completed; Phase 2; Phase 1

Conditions: Benign Prostatic Hypertrophy; Prostate Disease; Benign Prostatic Hyperplasia; BPH

Treatments: Drug: dehydrated alcohol

Study type: Interventional

Funder types: Industry

Identifiers

NCT00037141

AMS002

Details and patient eligibility

About

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.

Sex: Male

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.