Efficacy and safety of terazosin versus tamsulosin monotherapy for ureteral stent–related lower urinary tract symptoms: a double-blind randomized controlled trial

Abstract Background: Indwelling ureteral stents frequently cause stent-related symptoms (SRSs) that negatively impact patients’ health-related quality of life. This double-blind randomized controlled trial aimed to evaluate and compare the therapeutic efficacy and safety of tamsulosin versus terazosin monotherapy in alleviating stent-induced morbidity in patients undergoing retrograde ureteral stenting. Methods: Ninety patients with unilateral urinary tract calculi scheduled for retrograde ureteral stenting were randomized (1:1) to receive either tamsulosin (0.4 mg once daily) or terazosin (2 mg once daily) immediately after stent insertion until stent removal (4–6 weeks). The primary outcomes were evaluated at baseline and at the time of stent removal using the Ureteral Stent Symptom Questionnaire (USSQ), the International Prostate Symptom Score (IPSS), and a Quality of Life (QoL) index. Safety and adverse events were monitored throughout the trial. Results: Baseline demographic and clinical characteristics were homogeneous between the two cohorts (P>0.05). At stent removal, patients receiving tamsulosin demonstrated significantly lower (better) scores in the USSQ urinary symptoms domain compared with the terazosin group (19.20 ± 2.15 vs. 21.55 ± 6.02; P=0.017).Similarly, the tamsulosin group exhibited significantly superior outcomes in general health (10.13 ± 1.68 vs. 11.77 ± 4.63;P=0.029) and additional complications domains (8.17 ± 0.61 vs. 9.08 ± 2.29; P=0.013).Voiding dysfunction measured by IPSS was significantly lower in the tamsulosin group (2.11 ± 1.06 vs. 5.27 ± 2.86; P=0.038). No significant differences were observed regarding body pain, sexual function, daily work performance, or overall QoL (P>0.05). Both drugs were well tolerated, with minor self-limiting adverse events (dizziness and nasal congestion) and no severe orthostatic hypotensive episodes. Conclusions: While both α 1 -blockers were safe and well tolerated, tamsulosin monotherapy demonstrated superior efficacy over terazosin in reducing stent-induced lower urinary tract symptoms, improving general health, and minimizing stent-related complications. Trial registration: Iranian Registry of Clinical Trials (IRCT) IRCT20220117060982N1 (Registered 17 January 2022)