Finasteride following balloon dilatation of the prostate. A double-blind, placebo-controlled, multicenter study.

Background and aims: To evaluate the efficacy, safety and tolerability of finasteride administered for 24 months following successful balloon dilatation in patients with benign prostatic hyperplasia (BPH).

Patients and methods: 75 patients with moderate to severe symptoms of benign prostatic hyperplasia were first treated with balloon dilatation. After a 4-week placebo runin period, 64 patients with successful dilatation and over 50 % reduction in symptoms were randomized to receive either finasteride (33 pts.) at 5 mg/day or placebo (31 pts.) for 24 months. Altogether 12 patients dropped out at some stage, and the final analysis hence included 27 patients in the finasteride group and 25 patients in the placebo group.

Results: The symptom scores increased by an average of 3.2 points in the finasteride group and 4.4 points in the placebo group during two years. The mean maximum flow in the finasteride group remained constant: 13.7 ml/s at baseline and 13.9 ml/s at 24 months. In the placebo group the mean maximum flow decreased from 13.3 ml/sec to 11.2 ml/s. During the two-year study period, neither of the groups displayed any changes in residual urine. The above mentioned changes were not statistically significant, however. Prostate volume and serum PSA were significantly lower in the finasteride group (p < 0.001). The groups did not differ with regard to side-effects.

Conclusions: On the basis of the findings, BPH patients with moderate to severe symptoms can be treated with balloon dilatation. The effect of balloon dilatation is quick, and it alleviates the patients' symptoms immediately. Finasteride treatment maintains the positive effect of balloon dilatation. This combination of treatment is tolerated well and side-effects are rare. The favourable effect of balloon dilatation was maintained for at least two years. Finasteride treatment diminished significantly both prostate volume and serum prostate-specific antigen after balloon dilatation compared to placebo treatment.