Benign Prostatic Hyperplasia
Conditions
Keywords
adverse events, clinical trial methodology
Brief summary
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.
Detailed 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).
Interventions
None listed
Sponsors
University of California, San Francisco
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
50 Years to No maximum
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
Countries
United States
Outcome results
None listed