A critical assessment of the effects of tamsulosin and solifenacin as monotherapies and as a combination therapy for the treatment of ureteral stent-related symptoms: a 2 × 2 factorial randomized trial

Objective: To assess the efficacy of tamsulosin, solifenacin, and combination therapy of both agents for the treatment of ureteral stent-related symptoms (SRSs). Methods: An open-label, randomized controlled trial was conducted with 112 patients who underwent unilateral ureteral stent insertion following ureteroscopic stone surgery. Patients were randomized with a 2 × 2 factorial design to one of four groups, i.e., A (control), B (tamsulosin 0.2 mg once daily), C (solifenacin 5 mg once daily), and D (both active treatments). Patients were evaluated at week 2 by the ureteral stent symptom questionnaire (USSQ). The primary efficacy outcome was the urinary symptom score of the USSQ, and the secondary efficacy outcomes were the scores in the other five USSQ domains, the Euro-QOL score, and oral analgesic requirements during the 2 weeks. Efficacy outcomes were primarily analyzed for the per-protocol set population. Results: The four groups were generally well balanced in terms of baseline characteristics. Eighty-one patients (72.3 %) completed the study protocol. Comparison of the six USSQ domain scores at week 2 showed no differences between the four groups. Similarly, comparison of the domain scores stratified by tamsulosin or solifenacin medication showed no differences for either medication. The other secondary outcomes were also similar in the group comparisons. Conclusions: Neither tamsulosin nor solifenacin medications provide beneficial effects for relieving various SRSs. In addition, the combination therapy did not have beneficial effects. Further studies are warranted to determine the benefit of medical therapy for the treatment of SRSs and to determine the optimal management strategy for SRSs.