- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07566416
MIRABEGRON AND UAS OUTCOMES DURING RIRS
May 12, 2026 updated by: Arif Bedirhan Bayraktar, Ankara Training and Research Hospital
THE EFFECT OF PREOPERATIVE MIRABEGRON ON URETERAL ACCESS SHEATH INSERTION SUCCESS AND URETERAL INJURY DURING RETROGRADE INTRARENAL SURGERY: A RETROSPECTIVE COMPARATIVE STUDY
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
131
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Altındağ
-
Ankara, Altındağ, Turkey (Türkiye)
- Ankara Training and Research Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
patients scheduled for RIRS due to kidney stones
Description
Inclusion Criteria:
- patients scheduled for RIRS due to kidney stones
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Mirabegron Group
Patients using mirabegron for overactive bladder and scheduled for retrograde intrarenal surgery due to kidney stones.
|
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 Group
Not using mirabegron and scheduled retrograde intrarenal surgery due to kidney stones.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Ureteral access sheath insertion rate
Time Frame: From January 2018 to October 2021
|
From January 2018 to October 2021
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Ureteral injury rate
Time Frame: From January 2018 to October 2024
|
From January 2018 to October 2024
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2018
Primary Completion (Actual)
October 30, 2021
Study Completion (Actual)
February 10, 2025
Study Registration Dates
First Submitted
April 28, 2026
First Submitted That Met QC Criteria
April 28, 2026
First Posted (Actual)
May 5, 2026
Study Record Updates
Last Update Posted (Actual)
May 14, 2026
Last Update Submitted That Met QC Criteria
May 12, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Male Urogenital Diseases
- Calculi
- Pathological Conditions, Anatomical
- Kidney Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urolithiasis
- Urinary Calculi
- Nephrolithiasis
- Pathological Conditions, Signs and Symptoms
- Kidney Calculi
Other Study ID Numbers
- UASPULS2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Due to patient confidentiality, this information can be shared with official permission.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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