[Medical treatment of prostatic adenoma. Controlled trial: PA 109 vs placebo in 110 patients].

110 patients presenting with a prostatic adenoma sufficiently symptomatic to be treated medically, but not requiring surgical management, were included in a controlled test whose effectiveness was assessed after one month on the basis of objective criteria (nocturnal pollakiuria, urinary output, postmictional residue) and subjective criteria (dysuria, patients' opinions). PA 109 appeared significantly more effective than a placebo, especially in the objective criteria (p less than 10(-9]. Perfectly tolerated, clinically and biologically, this efficacy was again found in a supplementary study of forty seven patients, with a mean follow-up of 14.6 months, and over 2 1/2 years in some cases. Under the study conditions, and on the basis of the study criteria, PA 109 seems a good treatment for mictional disorders associated with non-surgical adenomas of the prostate.

RCT Entities:   Population Interventions Outcomes