The results of the ALFAUR (ALFuzosin in Acute Urinary Retention) study, announced today at the XIXth European Association of Urology (EAU) Congress in Vienna, Austria, indicate that the uroselective alpha1-blocker alfuzosin 10 mg once daily (OD) may have a beneficial effect in the management of male patients suffering from acute urinary retention (AUR), a sudden inability to pass urine that results in a painful distension of the bladder, requires immediate management with urethral catheterization and could necessitate surgical intervention.
ALFAUR was a double-blind, placebo-controlled trial including 363 patients with a first episode of AUR related to benign prostatic hyperplasia (BPH). The ALFAUR trial was conducted in two phases. In the first phase of the study patients were randomised to receive alfuzosin 10 mg OD or placebo for a period of 2 to 3 days from the beginning of catheterization to a trial without catheter (TWOC). In this phase of the trial, alfuzosin 10 mg OD had a higher rate of successful voiding of the bladder after catheter removal compared with placebo (61.9% versus 47.9 percent, p=0.012).
Alfuzosin 10 mg OD almost doubled the likelihood of a successful TWOC in these patients and its beneficial effect was particularly marked in patients with a high risk of TWOC failure, i.e. men over 65 years of age and/or with a retention volume of more than 1,000 ml. In the second phase of the ALFAUR study, all patients who were successfully voided in the first phase were re-randomized to receive alfuzosin 10 mg OD or placebo for a further period of six months to evaluate whether alfuzosin was able to reduce the need for BPH-related surgery defined by the recurrence of AUR or symptomatic impairment.
The results of this phase of the study showed that:
- alfuzosin 10mg OD administered for six months following a successful TWOC reduces the risk of BPH surgery by almost 30% compared to placebo,
- this result is even more marked at month 1 and month 3 (respectively 61% and 53% risk reduction; p=0.04)
"The ALFAUR trial demonstrates that alfuzosin, through its action on risk factors and sympathetic overactivity, allows for rapid catheter removal in patients with AUR and also significantly reduces the recurrence of AUR and the need for BPH-related surgery in comparison with placebo in the medium term.