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Questioning Patients About Adverse Medical Events: A Randomized Controlled Trial

This study has been completed.
Information provided by:
University of California, San Francisco Identifier:
First received: September 13, 2005
Last updated: NA
Last verified: April 2003
History: No changes posted
This trial studies whether 3 different methods of asking patients about adverse medical events in a clinical trial affects the rate of reported side effects.

Benign Prostatic Hyperplasia

Study Type: Observational
Study Design: Allocation: Random Sample
Primary Purpose: Screening
Time Perspective: Cross-Sectional
Time Perspective: Prospective
Official Title: Questioning Patients About Adverse Medical Events: A Randomized Controlled Trial

Further study details as provided by University of California, San Francisco:

Estimated Enrollment: 214
Study Start Date: April 2002
Estimated Study Completion Date: April 2003
Detailed Description:
214 patients involved in a larger randomized controlled trial of the herb, saw palmetto, for benign prostatic hyperplaisa were randomly assigned to 3 different methods of adverse event ascertainment after a 1-month placebo run-in visit. Two methods of ascertainment were open ended questions, and 1 was a checklist. Patients were blinded to group assignment, but investigators were aware (single blind). All patients had taken placebo for one month, but had been told it was a study drug (single blind).

Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male, age > 49, American Urological Association Symptom Index > 8
  • Max urine flow rate > 4 and < 15

Exclusion Criteria:

  • prior prostate cancer or surgery
  • use of medications that affect urination
  • severe concomitant illness
  Contacts and Locations
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Please refer to this study by its identifier: NCT00187616

United States, California
San Francisco VA Medical Center
San Francisco, California, United States, 94121
Sponsors and Collaborators
University of California, San Francisco
Principal Investigator: Stephen Bent, MD University of California, San Francisco
  More Information Identifier: NCT00187616     History of Changes
Other Study ID Numbers: STEPAE-001
Study First Received: September 13, 2005
Last Updated: September 13, 2005

Keywords provided by University of California, San Francisco:
adverse events
clinical trial methodology

Additional relevant MeSH terms:
Prostatic Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male processed this record on April 28, 2017