Comparison of the Efficacy of Alpha-Blockers and Mirabegron on Symptoms Associated With Double-J Stent Implanted After Retrograde Intrarenal Surgery
Conditions: Ureteral Stent-Related Symptoms
Sponsor: University of Gaziantep

Study Protocol – Cover Page 
Official Study Title: 
A Prospective, Randomized Study Comparing the Effect of Alfuzosin, Mirabegron, and Their 
Combination on DJ Stent-Related Symptoms After RIRS 
 
NCT Number: (Pending) 
 
Document Type: Study Protocol 
Date: May 22, 2025 
Sponsor: Gaziantep University 
Principal Investigator: Dr. Mehmet Öztürk 
COMPARISON OF THE EFFICACY OF ALPHA-BLOCKERS AND 
MIIRABEGRON ON SYMPTOMS ASSOCIATED WITH DJ STENT 
IMPLANTED  AFTER RETROGRADE INTRARENAL SURGERY 
ABSTRACT 
Introduction: This study aimed to evaluate the efficacy of alfuzosin, mirabegron, and their 
combination on stone-free rates, residual fragments, stent-related pain, and lower urinary tract 
symptoms (LUTS) in patients undergoing double-J (DJ) stent placement following retrograde 
intrarenal surgery (RIRS). 
Methods: A prospective, randomized, single-center trial was conducted between February 2022 
and December 2023 at Gaziantep University. A total of 103 patients who underwent RIRS for 
unilateral renal stones (1–2 cm) followed by DJ stenting were enrolled. Patients were randomized 
into four groups: Group 1 (control, no medication), Group 2 (alfuzosin 10 mg/day), Group 3 
(mirabegron 50 mg/day), and Group 4 (alfuzosin + mirabegron). Pain and LUTS were assessed at 
30 days postoperatively using the Visual Analog Scale (VAS) and Overactive Bladder-Validated 8 
(OAB-V8) form. 
Results: The mean age was 43.55 ± 13.93 years. No statistically significant difference was found 
between groups in stone-free rates, residual stones, pain, or LUTS (p > 0.05). Group 2 (alfuzosin) 
had the lowest mean VAS (1.69 ± 1.52) and OAB-V8 (13.5 ± 7.37) scores, though not statistically 

significant when compared to the control group (p = 0.112 and p = 0.592, respectively). Residual 
stones were detected in 27.2% of patients, and stone size was a significant predictor (p = 0.025). 
Conclusion: The use of alfuzosin and mirabegron alone or in combination did not have a 
significant effect on stone-free rates, procedural  pain and LUTS. However, alfuzosin may have 
potential benefits in both pain control and favorable effects on storage symptoms. Further larger-
scale studies are warranted. 
Keywords: Retrograde intrarenal surgery, double-J stent, alfuzosin, mirabegron, stent-related 
symptoms