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Safety/tolerability study of Alcohol Injection for Treatment of BPH (enlarged prostate)



Safety/tolerability study of Alcohol Injection for Treatment of BPH (enlarged prostate)

For Condition: Benign Prostatic Hypertrophy,Benign Prostatic Hyperplasia,Prostate Disease,BPH
Status: Recruiting
Sponsor(s): American Medical Systems ,
Synopsis: 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.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Randomized, Historical Control, Parallel Assignment
Minimum Age/Maximum Age: 50 Years/80 Years
Genders: Male
Protocol Entry 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.
Total Enrollment: 150

Location and Contact Information:

Stanford University Health Services *Recruiting*
Stanford,  California,  94305
United States
Recruiting Nushin  Namazi 650-498-4240

Oregon Urology Specialists *Recruiting*
Eugene,  Oregon,  97401
United States
Recruiting Tamara  Whittle 541-284-5508

Urological Sciences Research Foundation *Recruiting*
Culver City,  California,  90230
United States
Recruiting Research  Office 310-838-6347

Albany Medical Center *Recruiting*
Albany,  New York,  12208-3499
United States
Recruiting Brenda  Romeo 518-262-8579

Naval Medical Center *Recruiting*
San Diego,  California,  83739
United States
Recruiting Terry  Rogers 619-532-6781

Neil Baum, M.D. *Recruiting*
New Orleans,  Louisiana,  70115
United States
Recruiting Kati  Mencel 504-891-8454

University of Vermont *Recruiting*
Burlington,  Vermont,  05403
United States
Recruiting Martha  Bunnell 802-847-6108


Additional Information:
Study ID Numbers:
  AMS002; 
Study Start Date: March 2002
Record last reviewed: July 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00037141

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