Patient recruitment to and cost of a prospective trial of medical treatment for benign prostatic hyperplasia.

Abstract

409 consecutive patients, referred by general practitioners for assumed benign prostatic hyperplasia (BPH), were evaluated for inclusion into a hormone therapy trial for BPH. 97 patients were excluded initially. Upon examination of the 312 remaining patients, 221 were found to be ineligible for various reasons and 11 refused to participate. Other patients were excluded after a second, more extensive examination and 5 patients withdrew during the trial. We are now left with 66 patients (16.1% of the patients initially referred), of which approximately 33 are receiving placebo treatment. The financial costs for the hospital to carry out a drug trial with approximately 65 evaluable patients is estimated to exceed 40,000 pounds.