Preliminary study of efficacy of doxazosin as a medical expulsive therapy of distal ureteric stones in a randomized clinical trial

Abstract

Objectives: To assess the clinical efficacy of doxazosin as the medical-expulsive therapy for distal ureterolithiasis.

Methods: A total of 65 patients with a symptomatic 4-7 mm distal ureteral stone were included in the study. Patients were randomized to 1 of the 2 treatment groups. Group 1 (n=32 patients) was the control group and received diclofenac sodium 50 mg for their pain and group 2 (n=33 patients) received doxazosin (2 mg daily at the night) along with diclofenac sodium 50 mg. The treatment duration was until stone expulsion or 28 days, whichever come first. The primary endpoint of the study was the stone expulsion rate. The secondary endpoints included time to stone expulsion, use of analgesics, and number of emergency room visits, hospitalizations, and drug side effects. Statistical analyses were performed using chi-square test and Fisher exact test.

Results: Both groups were comparable in terms of demographic, clinical, and stone-related parameters. Stone expulsion rate was significantly higher in the treatment group (38% for group 1 and 70% for group 2, P=.009) while the expulsion time was significantly lesser in group 2 patients (P=.005). During the treatment period, we observed significant differences between the 2 groups in the number of pain episodes and analgesic used (P=.0001). None of the patients in either groups reported adverse drug-related events.

Conclusions: Doxazosin significantly improves stone expulsion and is associated with decreased colic frequency and use of analgesia. It is also well tolerated with no adverse drug-related events.