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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
  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)

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   (Adult, Senior)
Sexes 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

ClinicalTrials.gov Identifier: NCT00037141     History of Changes
Other Study ID Numbers: AMS002
Study First Received: May 15, 2002
Last Updated: October 4, 2007

Keywords provided by American Medical Systems:
Prostate
BPH
Prostatitis

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

ClinicalTrials.gov processed this record on September 19, 2017