Recruitment for a clinical trial of drug treatment for benign prostatic hyperplasia.

Objectives: To evaluate the effectiveness of various recruitment strategies for a 6-year multicenter clinical trial of medical therapy for benign prostatic hyperplasia, the Medical Therapy of Prostatic Symptoms Trial.

Methods: How participants learned about the trial was obtained during initial contact with clinical centers and at the first screening visit. The yield of randomized participants from the initial contact and first screening visit was calculated for each of the recruitment techniques.

Results: During a period of 28 months, 16,723 potential trial participants made an initial contact with the 17 clinical centers, and 2931 men were randomized. An average of four initial contacts were required for each first screen visit and six per randomized participant. Newspaper (29.9%) and mail (26.7%) were the two leading sources of randomized participants. Medical sources (9.6%), radio (8.8%), and newsletters (8.4%) were also important sources. All clinical centers achieved or exceeded their recruitment goals.

Conclusions: Mass mail and newspaper were the most effective recruitment techniques to enlist the interest of men with urinary symptoms for a long-term trial of drug therapy for benign prostatic hyperplasia.