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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00037141
Recruitment Status : Completed
First Posted : May 17, 2002
Last Update Posted : October 10, 2007
Information provided by:
American Medical Systems

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

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Study Type : Interventional  (Clinical Trial)
Enrollment : 150 participants
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 : March 2002
Study Completion Date : March 2004

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.

Layout table for additonal information Identifier: NCT00037141    
Other Study ID Numbers: AMS002
First Posted: May 17, 2002    Key Record Dates
Last Update Posted: October 10, 2007
Last Verified: June 2004
Keywords provided by American Medical Systems:
Additional relevant MeSH terms:
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Prostatic Hyperplasia
Prostatic Diseases
Pathologic Processes
Genital Diseases, Male
Pathological Conditions, Anatomical
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs