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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-03-31

Study Completion Date

2004-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Prostate Disease BPH Benign Prostatic Hyperplasia Benign Prostatic Hypertrophy

Keywords

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Prostate BPH Prostatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Interventions

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dehydrated alcohol

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Other Identifiers

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AMS002

Identifier Type: -

Identifier Source: org_study_id