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NCT00037141 Clinical Trial

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

Benign Prostatic Hyperplasia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00037141
Other study ID # AMS002
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received May 15, 2002
Last updated October 4, 2007
Start date March 2002
Est. completion date March 2004

Study information
Verified date June 2004
Source American Medical Systems
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 150
Est. completion date March 2004
Est. primary completion date
Accepts healthy volunteers No
Gender Male
Age group 50 Years to 80 Years
Eligibility 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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• dehydrated alcohol

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
American Medical Systems
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