BACKGROUND: Prostatodynia is a common and often disabling condition that affects males and has the characteristics of a somatoform pain disorder. It presents with urogenital pain and urinary symptoms. Failure of conventional treatment and a successful uncontrolled pilot study with fluvoxamine in this condition prompted this study. METHOD: In a randomized double-blind trial, 42 patients with prostatodynia were assigned to receive either fluvoxamine (N = 21) or placebo (N = 21) for up to 8 weeks. Doses were adjusted according to therapeutic need. The median dose of fluvoxamine was 150 mg (range, 50-300 mg). Self-rated pain scores, urinary flow rates, and depression and anxiety scores were measured at baseline and several times throughout the study period. RESULTS: The groups were similar at baseline, and the results were examined by intent-to-treat analysis either using the last observation carried forward or, in the case of dichotomous measures, counting treatment dropouts as treatment failures. Fluvoxamine was significantly more likely to reduce pain intensity (p =.01) and normalize urinary flow rates (p =.03) with a clinically significant number needed to treat value of 1.5 (confidence interval = 1.12 to 5.50). This therapeutic effect could not be attributed to change in mood, as the 2 groups did not differ with respect to affective ratings at the end of the study. The fluvoxamine-treated group had significantly lower (p =.02) final scores on the General Health Questionnaire, indicating an overall benefit from pain relief. CONCLUSION: Fluvoxamine is a viable treatment for prostatodynia. Dose-ranging studies and longer trials are needed to evaluate this agent further.