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Alfuzosin and Mirabegron for Double-J Stent Symptoms

U

University of Gaziantep

Status

Completed

Conditions

Ureteral Stent-Related Symptoms

Study type

Observational

Funder types

Other

Identifiers

NCT07018934
2024/05

Details and patient eligibility

About

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.

Full 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

Enrollment

100 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

100 participants in 4 patient groups

1
Description:
Group 1 : The group that did not receive medical treatment
2
Description:
Group 2 : Alfuzosin 10 mg/d oral
3
Description:
Group 3 : Mirabegron 50 mg/d oral
4
Description:
Group 4 : Combination therapy with alfuzosin + Mirabegron

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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