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

Primary Purpose

Prostate Disease, BPH, Benign Prostatic Hyperplasia

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
dehydrated alcohol
Sponsored by
American Medical Systems
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Disease focused on measuring Prostate, BPH, Prostatitis

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)MaleDoes not accept 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.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    May 15, 2002
    Last Updated
    October 4, 2007
    Sponsor
    American Medical Systems
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00037141
    Brief Title
    Safety/Tolerability Study of Alcohol Injection for Treatment of BPH (Enlarged Prostate)
    Official Title
    Evaluation of the Safety and Tolerability of Transurethral Alcohol Injection for the Treatment of BPH (Enlarged Prostate)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2004
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2002 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    March 2004 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    American Medical Systems

    4. Oversight

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Prostate Disease, BPH, Benign Prostatic Hyperplasia, Benign Prostatic Hypertrophy
    Keywords
    Prostate, BPH, Prostatitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Allocation
    Randomized
    Enrollment
    150 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    dehydrated alcohol

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.

    12. IPD Sharing Statement

    Learn more about this trial

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

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