Role of combined use of ketoconazole and tamsulosin in management of acute urinary retention due to benign prostatic obstruction (a randomized controlled trial)

Abstract

Ketoconazole has the ability to lower serum testosterone to castrate level within 48 h. As the prostate is an androgen-dependent organ, we investigated the effect of the use of tamsulosin in combination with ketoconazole in cases of acute urinary retention (AUR) due to benign prostatic obstruction (BPO). We recruited patients with AUR secondary to BPO but those with hepatic or renal impairment were excluded. Following urethral catheterization, the participants were randomized into two equal groups. The first group received tamsulosin (0.4 mg o.d.) and ketoconazole (200 mg t.d.s.) while the second one had tamsulosin and placebo. The drugs were maintained for 7 days and then the patients were put on trial without catheter (TWOC). The successful cases were assessed with peak flow rate (PFR) and the post-void residual urine volume (PVRV) was also estimated. We included 106 men with a mean age of 64.1±5.2 years and a mean prostate size of 61.6±14.6 g in the two groups. The received medications were well tolerated by all patients and none of them had discontinued the prescribed drugs. The incidence of the successful TWOC was significantly higher in the combined treatment group (77.35%) compared to the tamsulosin group (58.84%; P=0.01). Among those who had a successful TWOC, the PFR and the PVRV were also significantly better in the combined treatment group compared to the other one (P=0.001). Patients with AUR due to BPO can be treated safely with a combination of ketoconazole and tamsulosin to get a better success rate of TWOC.