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NCT Number: NCT07018934

Alfuzosin and Mirabegron for Double-J Stent Symptoms

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.

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Key information

Conditions

Ureteral Stent-Related Symptoms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Lower Urinary Tract Symptoms Male Urogenital Diseases Nephrolithiasis Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Urogenital Diseases Urolithiasis Urologic Diseases Urological Manifestations

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Gaziantep University Faculty of Medicine Hospital

Gaziantep, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Stent-Related Pain Score

    Time frame: Day 7 postoperatively and Day 14 postoperatively.

    Pain score ranges from 0 to 39 (higher scores indicate worse pain).

  2. Lower Urinary Tract Symptom (LUTS) Score

    Time frame: Day 7 postoperatively and Day 14 postoperatively

    IPSS ranges from 0 to 35 (higher scores indicate more severe LUTS).

Secondary outcomes

  1. Stone-Free Rate

    Time frame: Day 14 postoperatively

    Proportion of patients with no residual fragments > 2 mm on NCCT

  2. Residual Fragment Status

    Time frame: Day 14 postoperatively

    Categorization of residual fragments into 0 mm, 1-2 mm, or > 2 mm

Sponsors and collaborators

Lead sponsor

University of Gaziantep

Other

Registry information

Official study title

Comparison of the Efficacy of Alpha-Blockers and Mirabegron on Symptoms Associated With Double-J Stent Implanted After Retrograde Intrarenal Surgery

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 13, 2025
Registry last updated
Jun 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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