Antibiotic prophylaxis for transrectal needle biopsy of the prostate: a randomized controlled study.

OBJECTIVES: To determine the effect of antibiotic prophylaxis on infective complications after transrectal needle biopsy of the prostate. PATIENTS AND METHODS: Between June 1996 and September 1998, 231 patients who satisfied the inclusion and exclusion criteria entered the study; the patients were randomized into three groups. Each patient underwent transrectal needle biopsy of the prostate after a cleansing enema at 06:00 hours. Patients in group 1 (75) then received a placebo tablet twice a day for 3 days; those in group 2 (79) were given a single dose of ciprofloxacin (500 mg) and tinidazole (600 mg), while those in group 3 (77) were given the same combination twice a day for 3 days. Urine cultures were obtained 48 h after the biopsy and blood cultures only from patients who developed fever. The complications (categorized as infective or noninfective) occurring in the three groups were compared using the chi-square test.
RESULTS: Noninfective complications included were lower urinary tract symptoms, rectal bleeding, haematuria and perineal pain. The infective complications included urinary tract infection and fever. There was no significant difference among the three groups in noninfective complications (27, 29 and 31 in groups 1-3, respectively) but the incidence of infective complications (19, six and eight, respectively) was significantly higher in group 1 (P = 0.003). However, the difference was significant only for urinary tract infection (P = 0.01) and not for fever.
CONCLUSIONS: In selected patients a single dose of ciprofloxacin-tinidazole is adequate prophylaxis for transrectal needle biopsy of the prostate. The present urinary infection rate was higher if no antibiotics were used. Continuing the antibiotic prophylaxis for 3 days offered no benefit over single-dose prophylaxis.

RCT Entities:   Population Interventions Outcomes