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

This study has been completed.
Sponsor:
Information provided by:
American Medical Systems
ClinicalTrials.gov Identifier:
NCT00037141
First received: May 15, 2002
Last updated: October 4, 2007
Last verified: June 2004
History of Changes
  Purpose

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.


Condition Intervention Phase
Prostate Disease
BPH
Benign Prostatic Hyperplasia
Benign Prostatic Hypertrophy
 Drug: dehydrated alcohol
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: Evaluation of the Safety and Tolerability of Transurethral Alcohol Injection for the Treatment of BPH (Enlarged Prostate)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by American Medical Systems:

Estimated Enrollment: 150
Study Start Date: March 2002
Estimated Study Completion Date: March 2004
  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00037141     History of Changes
Other Study ID Numbers: AMS002
Study First Received: May 15, 2002
Last Updated: October 4, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by American Medical Systems:
Prostate
BPH
Prostatitis

Additional relevant MeSH terms:
Prostatic Hyperplasia
Hyperplasia
Hypertrophy
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes
Pathological Conditions, Anatomical
Ethanol
 Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 23, 2013