NCT07566416

Brief Summary

The aim of this study is to evaluate whether there is a difference in the passage rate of the ureteral access sheath between patients who used mirabegron (a beta-3 receptor agonist) for overactive bladder and those who underwent retrograde intrarenal surgery for kidney stones, and those who did not use mirabegron. Considering that beta-3 receptors in the smooth muscle of the ureter cause relaxation in the ureter, the hypothesis that the passage rate of the access sheath increases in those using mirabegron, thus facilitating access to kidney stones and improving surgical success, will be investigated.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2025

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 28, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 5, 2026

Completed
Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

2.9 years

First QC Date

April 28, 2026

Last Update Submit

April 28, 2026

Conditions

Keywords

kidney stonemirabegronureteral access sheathretrograde intrarenal surgery

Outcome Measures

Primary Outcomes (1)

  • Ureteral access sheath insertion rate

    From January 2022 to December 2024

Secondary Outcomes (1)

  • Ureteral injury rate

    From January 2022 to December 2024

Study Arms (2)

Mirabegron Group

Patients using mirabegron for overactive bladder and scheduled for retrograde intrarenal surgery due to kidney stones.

Procedure: Retrograde intrarenal surgery

Control Group

Not using mirabegron and scheduled retrograde intrarenal surgery due to kidney stones.

Procedure: Retrograde intrarenal surgery

Interventions

In our study, we evaluated the üreteral access sheath insertion rate in patients already using mirabegron for overactive bladder and scheduled for RIRS surgery for kidney stones. No additional intervention was performed beyond the routine surgical procedure.

Control GroupMirabegron Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients scheduled for RIRS due to kidney stones

You may qualify if:

  • patients scheduled for RIRS due to kidney stones

You may not qualify if:

  • preoperative ureteral stenting,
  • ureteral strictures, history of ureteral or bladder surgery,
  • anatomical abnormalities of the urinary tract,
  • active urinary tract infection,
  • pregnancy,
  • uncontrolled hypertension (systolic blood pressure ≥180 mmHg, diastolic blood pressure ≥110 mmHg),
  • use of medications affecting ureteral smooth muscle tone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Training and Research Hospital

Ankara, Altındağ, Turkey (Türkiye)

Location

Related Publications (2)

  • Akinci A, Sanci A, Babayigit M, Gogus C. Does preoperative alpha-blocker use affect the results of flexible ureterorenoscopy? Actas Urol Esp (Engl Ed). 2025 Nov;49(9):501836. doi: 10.1016/j.acuroe.2025.501836. Epub 2025 Sep 10. English, Spanish.

  • Ermis O, Sabuncu K, Kactan C, Karakus B, Surmeli B, Boz MY, Horuz R. Mirabegron administration for the prevention of ureteral injuries during ureteral access sheath insertion. World J Urol. 2026 Jan 27;44(1):130. doi: 10.1007/s00345-026-06225-3.

MeSH Terms

Conditions

Kidney Calculi

Condition Hierarchy (Ancestors)

NephrolithiasisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
UROLOGIST

Study Record Dates

First Submitted

April 28, 2026

First Posted

May 5, 2026

Study Start

January 1, 2022

Primary Completion

December 12, 2024

Study Completion

February 10, 2025

Last Updated

May 5, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Due to patient confidentiality, this information can be shared with official permission.

Locations