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

Sponsor

American Medical Systems (Industry)

Overall Status

Completed

CT.gov ID

NCT00037141

Collaborator

(none)

150

Enrollment

Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Disease BPH Benign Prostatic Hyperplasia Benign Prostatic Hypertrophy	Drug: dehydrated alcohol	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Primary Purpose:

Treatment

Official Title:

Evaluation of the Safety and Tolerability of Transurethral Alcohol Injection for the Treatment of BPH (Enlarged Prostate)

Study Start Date :

Mar 1, 2002

Study Completion Date :

Mar 1, 2004

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 80 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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.