Alfuzosin and Mirabegron for Double-J Stent Symptoms

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-01

Study Completion Date

2025-05-01

Brief Summary

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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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Detailed Description

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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

Conditions

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Ureteral Stent-Related Symptoms

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Group 1 : The group that did not receive medical treatment

No interventions assigned to this group

2

Group 2 : Alfuzosin 10 mg/d oral

No interventions assigned to this group

3

Group 3 : Mirabegron 50 mg/d oral

No interventions assigned to this group

4

Group 4 : Combination therapy with alfuzosin + Mirabegron

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No