Alfuzosin and Mirabegron for Double-J Stent Symptoms

Completed

• Conditions: Ureteral Stent-Related Symptoms

• Registration Number: NCT07018934
• Lead Sponsor: University of Gaziantep

Brief Summary

This prospective randomized controlled trial investigates the effects of alfuzosin, mirabegron, and their combination on stent-related symptoms and outcomes in patients undergoing DJ stent placement after retrograde intrarenal surgery (RIRS) for renal stones. The primary outcomes include stone-free rate and residual fragment status, while secondary outcomes focus on stent-related pain and lower urinary tract symptoms (LUTS). Patients will be randomly assigned to one of four groups: alfuzosin only, mirabegron only, combination therapy, or control. Pain and LUTS will be assessed using validated questionnaires such as the Ureteral Stent Symptom Questionnaire (USSQ) and IPSS.

Detailed Description

Retrograde intrarenal surgery (RIRS) is a commonly used minimally invasive procedure for the treatment of renal stones. Postoperative placement of double-J (DJ) stents is often necessary but can result in significant stent-related discomfort and lower urinary tract symptoms (LUTS), which negatively impact patient quality of life. Alfuzosin, an alpha-blocker, and mirabegron, a beta-3 agonist, are pharmacological agents known to reduce stent-related symptoms. This study aims to compare the individual and combined efficacy of these agents on stent-related pain, LUTS, and postoperative stone outcomes. Patients will be evaluated for stone clearance, residual fragments (by imaging), and symptom scores over a follow-up period of 2 to 4 weeks post-RIRS

Study Timeline

• Study Start: 2024-06-01
• Primary Completion: 2025-04-01
• Study Completion: 2025-05-01
• Study First Submitted: 2025-05-26
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-04
• Last Update Submitted: 2025-06-04
• Study First Posted: 2025-06-13
• Last Update Posted: 2025-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Undergoing RIRS and DJ stenting

Ability to provide informed consent

Exclusion Criteria

• Neurogenic bladder

Prostate volume >40 mL or significant LUTS at baseline

Contraindications to alpha-blockers or mirabegron

Hepatic or severe renal impairment

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Stent-Related Pain Score	Day 7 postoperatively and Day 14 postoperatively.	Pain score ranges from 0 to 39 (higher scores indicate worse pain).
Lower Urinary Tract Symptom (LUTS) Score	Day 7 postoperatively and Day 14 postoperatively	IPSS ranges from 0 to 35 (higher scores indicate more severe LUTS).

Secondary Outcome Measures

Name	Time	Method
Stone-Free Rate	Day 14 postoperatively	Proportion of patients with no residual fragments \> 2 mm on NCCT
Residual Fragment Status	Day 14 postoperatively	Categorization of residual fragments into 0 mm, 1-2 mm, or \> 2 mm

Trial Locations

Locations (1)

Gaziantep University Faculty of Medicine Hospital; 🇹🇷 Gaziantep, Turkey