Alfuzosin and Mirabegron for Double-J Stent Symptoms

NCT07018934 | Completed

• 1 other identifier: 2024/05
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Ureteral Stent-Related Symptoms

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Stent-Related Pain Score

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

  Day 7 postoperatively and Day 14 postoperatively.

• Lower Urinary Tract Symptom (LUTS) Score

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

  Day 7 postoperatively and Day 14 postoperatively

Secondary Outcomes (2)

• Stone-Free Rate

  Day 14 postoperatively

• Residual Fragment Status

  Day 14 postoperatively

Study Arms (4)

1

Group 1 : The group that did not receive medical treatment

2

Group 2 : Alfuzosin 10 mg/d oral

3

Group 3 : Mirabegron 50 mg/d oral

4

Group 4 : Combination therapy with alfuzosin + Mirabegron

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients aged 18 to 75 years undergoing retrograde intrarenal surgery (RIRS) for renal stones, followed by double-J (DJ) stent placement

You may qualify if:

• \- Undergoing RIRS and DJ stenting
• Ability to provide informed consent

You may not qualify if:

• Neurogenic bladder
• Prostate volume \>40 mL or significant LUTS at baseline
• Contraindications to alpha-blockers or mirabegron
• Hepatic or severe renal impairment

Sponsors & Collaborators

• University of Gaziantep: lead

Study Sites (1)

Gaziantep University Faculty of Medicine Hospital

Gaziantep, Turkey (Türkiye)

Location

Related Publications (4)

• Zhang K, Yan W, Li H, Chen J, Wang Q, Chai Y, Yuan L, Zhu G. Comparison of Mirabegron plus Tamsulosin and Tamsulosin Monotherapy for the Treatment of Ureteral Stent-Related Symptoms: A Prospective Randomized Study. Urol Int. 2022;106(12):1226-1232. doi: 10.1159/000526607. Epub 2022 Oct 14.

  PMID: 36244331 RESULT

• Uslu M, Yildirim U, Ezer M, Erihan IB, Sarica K. Residual fragment size following retrograde intrarenal surgery: a critical evaluation of related variables. Urolithiasis. 2023 Aug 9;51(1):100. doi: 10.1007/s00240-023-01478-8.

  PMID: 37556003 RESULT

• Geraghty RM, Davis NF, Tzelves L, Lombardo R, Yuan C, Thomas K, Petrik A, Neisius A, Turk C, Gambaro G, Skolarikos A, Somani BK. Best Practice in Interventional Management of Urolithiasis: An Update from the European Association of Urology Guidelines Panel for Urolithiasis 2022. Eur Urol Focus. 2023 Jan;9(1):199-208. doi: 10.1016/j.euf.2022.06.014. Epub 2022 Aug 1.

  PMID: 35927160 RESULT

• Yuk HD, Park J, Cho SY, Sung LH, Jeong CW. The effect of preoperative ureteral stenting in retrograde Intrarenal surgery: a multicenter, propensity score-matched study. BMC Urol. 2020 Sep 14;20(1):147. doi: 10.1186/s12894-020-00715-1.

  PMID: 32928162 RESULT

MeSH Terms

Conditions

Nephrolithiasis; Lower Urinary Tract Symptoms; Pain, Postoperative

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Study Record Dates

• First Submitted: May 26, 2025
• First Posted: June 13, 2025
• Study Start: June 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: May 1, 2025
• Last Updated: June 13, 2025

Record last verified: 2025-06

Locations

TU (1)