Benign Prostatic Hyperplasia Treatment Outcomes Pilot Study

摘要

The report summarizes a pilot study originally designed to address the questionof increased mortality following transurethral resection of the prostate (TURP) and the relative effectiveness of different treatment strategies for benign prostatic hyperplasia (BPH). A total of 175 patients at four clinical sites were recruited into the randomized component of the study; 99 patients were enrolled in non-randomized component. The typical patient was 68 years old, retired, had considerable medical comorbidity, and was moderately symptomatic, with a modestly reduced peak urine flow rate. Eighty-one patients were assigned to TURP, the dominant surgical procedure for the treatment of BPH in the U.S. The remaining patients accepted the following treatment assignments: watchful waiting (34), balloon dilation (29), alpha blocker (20), and open prostatectomy (11). Recruitment and randomization for the study, which began in September 1990, was discontinued in January 1993. Project data have contributed to the validation of the American Urological Association Symptom Index and BPH-specific health status measures. The data were used to explore measurement issues, including the relationship between symptoms and physiologic measures, the accuracy of the various measurements of prostate size, and the cardiovascular effects of TURP.