Alfuzosin and Mirabegron for Double-J Stent Symptoms

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07018934

Enrollment

100

Registered

2025-06-13

Start date

2024-06-01

Completion date

2025-05-01

Last updated

2025-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ureteral Stent-Related Symptoms

Keywords

Nephrolithiasis, Ureteral Stent-Related Symptoms, Lower Urinary Tract Symptoms, Postoperative Pain, Retrograde Intrarenal Surgery

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

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Turkey (Türkiye)

Outcome results