Trial | NCT00037141  Report issue

Title

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

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Indication/Condition

    BPH ...

  • Intervention/Treatment

    ethanol ...

  • Study Participants

    150
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.
Study Started
Mar 31
2002
Study Completion
Mar 31
2004
Last Update
Oct 10
2007
Estimate

Drug dehydrated alcohol

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.
No Results Posted