Effects of finasteride and cyproterone acetate on hematuria associated with benign prostatic hyperplasia: a prospective, randomized, controlled study.

Objectives: To evaluate the influence of two differently acting antiandrogens, finasteride (FIN) and cyproterone acetate (CPA), on the natural history of hematuria associated with benign prostatic hyperplasia (BPH) in a prospective, randomized, controlled study.

Methods: Forty-two patients with hematuria episodes due to BPH were randomly allocated to three subgroups of 14 patients each and treated daily with either 5 mg FIN or 100 mg CPA or were placed in a watchful waiting arm. Patients were evaluated at 3-month intervals, and 40 patients had at least 1 year of follow-up.

Results: Four patients in the FIN group (30%) and three in the CPA group (23%) presented with recurrent hematuria. In both groups, the bleeding episodes were treated conservatively and required no hospitalization. In the control group, 8 patients (57%) presented with recurrent bleeding; in 4, the bleeding was severe and required some form of intervention (catheterization or transurethral prostatectomy). When the frequency and severity of the hematuria episodes were analyzed over time, a statistically significant difference for FIN versus control was present at 9 and 12 months (analysis of variance, P = 0.035 and P = 0.009, respectively). A similar difference was evident for CPA versus control at 9 and 12 months (P = 0.028 and P = 0.008, respectively). No statistically significant difference was present between the FIN and CPA groups. Interestingly, no statistically significant effect in bleeding recurrence for both CPA and FIN over controls was present at 3 and 6 months of follow-up.

Conclusions: Both FIN and CPA seem to exert a comparable control in hematuria recurrence in patients with BPH, thus confirming the rationale behind the use of antiandrogens for such a purpose. Our results support the hypothesis that any antiandrogen, irrespective of the mode of action, would alter the natural history of BPH-associated hematuria. Interestingly, our results indicate that the speed of action of FIN may not be as rapid as previously described.