A randomized double-blind prospective study evaluating patient tolerance of transrectal ultrasound-guided biopsy of the prostate using prebiopsy rofecoxib.

OBJECTIVES

To assess the use of a prebiopsy outpatient analgesia using the nonsteroidal anti-inflammatory agent rofecoxib (Vioxx). Urologists perform approximately 500,000 transrectal ultrasound (TRUS)-guided biopsies of the prostate per year, commonly without analgesia. Recent reports, however, have determined that a significant proportion of patients undergoing TRUS-guided biopsies have pain.

METHODS

We performed a prospective randomized double-blind study of 56 men referred for TRUS biopsy of the prostate. They were randomly assigned to receive 50 mg of oral rofecoxib or placebo before TRUS biopsy. After the biopsies, the patients were asked to score the severity of pain by filling out a visual analog pain scale. At the end of 1 week, all patients were asked to mail in a questionnaire regarding the morbidity of the prostate biopsy, including dysuria, hematuria, urinary retention, postbiopsy fever, and rectal bleeding. Analysis was completed to assess whether rofecoxib decreased the patients' perception of pain. The postbiopsy morbidity of patients receiving placebo versus rofecoxib was compared.

RESULTS

Thirty-seven percent of patients receiving placebo and 42% of patients receiving rofecoxib had significant pain (5 or greater on the visual analog pain scale). The median pain score of patients receiving rofecoxib (4.0) versus placebo (4.0) was not significantly different statistically (P = 0.3139) using a Wilcoxon rank sum analysis. The incidence of postbiopsy morbidity was not different.

CONCLUSIONS

Our results confirm the findings of previous studies demonstrating that a significant proportion of patients undergoing prostate biopsies have pain. More importantly, we found that prebiopsy rofecoxib did not significantly decrease the patients' severity of discomfort. Finally, the morbidity after biopsy was not increased with the use of rofecoxib.