Experimental treatment of benign prostatic hyperplasia with transurethral balloon dilation of the prostate: preliminary study in 73 humans.

A prospective noncontrolled study of the safety and potential efficacy of transurethral balloon catheter dilation of the prostate (TUDP) in the treatment of benign prostatic hyperplasia (BPH) was performed in 73 subjects with moderate to severe symptoms and signs of prostatism who were selected on the basis of a quantitative symptom score (SS), uroflowmetry measurements, and residual urine volume. Seven patients had urinary retention. Mean age was 69.6 years (range, 59-95 years). TUDP was successfully accomplished in 70 patients (96%). There were no significant complications. Mean follow-up was 16.2 months (range, 6-36 months). Forty-six patients (66%) showed improved SS at the most recent follow-up. In 24 patients (34%) SS was unimproved, necessitating prostatectomy in 17 subjects (24%). Reduction in mean residual urine volume was not statistically significant. Only 38% of patients with median lobe enlargement showed improvement in SS, compared with 74% for the others. The authors conclude that TUDP is safe and shows promising effectiveness and that the ultimate demonstration of effectiveness requires a controlled clinical trial.