The Effect of Adenorm on the Frequency of Expulsion of Proximal Ureter Calculi: an Open Randomized Controlled Study

Abstract

Conservative expulsive therapy with the use of alpha-blockers is effective for stones of the lower third of the ureter. Our study was conducted to assess the effectiveness of tamsulosin as part of the drug Adenorm for removing stones from the proximal ureter.Materials and methods. An open, randomized controlled trial was conducted with 108 patients who agreed to the conservative treatment of a single radiopaque calculus of the upper third of the ureter with dimensions ≤6 mm. They were randomly assigned to group A (n=54, only general expulsive therapy) and group B (n=54, which received 0.4 mg of tamsulosin once a day). The primary measure of effectiveness was the frequency of the discharge of calculus (PSC) in the «population of patients with the intention to be treated» after 4 weeks of treatment. Secondary efficacy indicators were evaluated in the «population by protocol» and represented the time of the calculus, the indicator of the Euro-Quality-of-Life scale (EuroQOL – Euro Quality of Life) after the study, the need to take painkillers and the willingness to undergo conservative treatment again.Results. The two groups were well balanced according to the initial characteristics of the patients and the calculus. Seventy-nine patients (73.1%; 35 from group A and 44 from group B) completed the study protocol. The total CHOK was 60.2% (65/108). Group B had a higher FER (74.1%; 40/54) than Group A (46.3%; 25/54; p=0.003) and a significantly shorter stone transit time (average days, A: 19, 6 vs. B: 14.3; p=0.005). The groups did not differ on the EuroQOL scale and on the need for anesthesia, while 74.3% (26/35) of Group A and 90.9% (40/44) of Group B were ready to undergo conservative treatment (p=0.048). Univariate logistic regression analysis showed that stone size (OR=1.474; p=0.045) and treatment with tamsulosin (OR=3.314; p=0.004) significantly influenced the stone’s discharge. In multivariate analysis, only tamsulosin was statistically significant (OR=3.198; p=0.021).Findings. The use of tamsulosin as part of Adenorm was associated with a significantly better frequency of expulsion of stones and a shorter time of their passage, with primary single calculi of the upper third in sizes ≤ 6 mm compared with only conventional expulsive therapy. Our results show that, like patients with stones in the lower third of the ureter, conservative expulsive therapy using tamsulosin is a reasonable treatment option for patients and with calculi of the proximal third of the ureter.