Questioning Patients About Adverse Medical Events

University of California San Francisco (UCSF)

Status: Completed

Conditions: Benign Prostatic Hyperplasia

Study type: Observational

Funder types: Other

Identifiers

NCT00187616

STEPAE-001

Details and patient eligibility

About

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.

Full description

214 patients involved in a larger randomized controlled trial of the herb, saw palmetto, for benign prostatic hyperplasia 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).

Sex: Male

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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