Kidney StoneNCT07566416
MIRABEGRON AND UAS OUTCOMES DURING RIRS
An observational study of Kidney Stone and Retrograde Intrarenal Surgery (RIRS), run by Ankara Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Stone, Retrograde Intrarenal Surgery (RIRS), Ureteral Access Sheath
- What is being tested?
- Retrograde intrarenal surgery
- Type of treatment
- Surgery or procedure
- How many people
- 131 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2018to 10 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients scheduled for RIRS due to kidney stones
Who may be able to join
- patients scheduled for RIRS due to kidney stones
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Training and Research Hospital
Ankara, Altındağ
About this study
Official title: 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.
- Being tested
- Retrograde intrarenal surgery
- Keywords
- kidney stone, mirabegron, ureteral access sheath, retrograde intrarenal surgery
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrograde intrarenal surgeryProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Mirabegron Group | Patients using mirabegron for overactive bladder and scheduled for retrograde intrarenal surgery due to kidney stones. Receives: Procedure: Retrograde intrarenal surgery | |
| Control Group | Not using mirabegron and scheduled retrograde intrarenal surgery due to kidney stones. Receives: Procedure: Retrograde intrarenal surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ureteral access sheath insertion rate
Measured: From January 2018 to October 2021
Secondary outcomes (1)
Ureteral injury rate
Measured: From January 2018 to October 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2026
- Study start1 Jan 2018
- Primary completion30 Oct 2021
- Study completion10 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Kidney StoneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arif Bedirhan Bayraktar, Ankara Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07566416
- Sponsor's protocol ID
- UASPULS2026
- Status last verified
- May 2026
- First submitted
- 28 Apr 2026
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to patient confidentiality, this information can be shared with official permission.
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.
PubMed 40939838Ermis 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.
PubMed 41591575
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECT OF PREOPERATIVE MIRABEGRON ON URETERAL ACCESS SHEATH INSERTION SUCCESS AND URETERAL INJURY DURING RETROGRADE INTRARENAL SURGERY: A RETROSPECTIVE COMPARATIVE STUDY
- ClinicalTrials.gov ID
- NCT07566416
- Acronym / sponsor ID
- UASPULS2026
- Keywords
- kidney stone, mirabegron, ureteral access sheath, retrograde intrarenal surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Ankara Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 10 Feb 2025 (actual)
- First posted
- 5 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mirabegron Group | – | Procedure: Retrograde intrarenal surgeryPatients using mirabegron for overactive bladder and scheduled for retrograde intrarenal surgery due to kidney stones. |
| Control Group | – | Procedure: Retrograde intrarenal surgeryNot using mirabegron and scheduled retrograde intrarenal surgery due to kidney stones. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients scheduled for RIRS due to kidney stones
Key inclusion criteria (1 listed)
- patients scheduled for RIRS due to kidney stones
Key exclusion criteria (7 listed)
- preoperative ureteral stenting,
- ureteral strictures, history of ureteral or bladder surgery,
- anatomical abnormalities of the urinary tract,
- active urinary tract infection,
- pregnancy,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Retrograde intrarenal surgeryIn 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. | Procedure or surgery | Control Group, Mirabegron Group |
Primary outcome
Ureteral access sheath insertion rate
Time frame: From January 2018 to October 2021
1 secondary outcome
Ureteral injury rate
Time frame: From January 2018 to October 2024
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Results publication: PubMed 40939838Akinci 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.
- Results publication: PubMed 41591575Ermis 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.
- Individual participant dataSharing planned: No. Due to patient confidentiality, this information can be shared with official permission.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Stone and Retrograde Intrarenal Surgery (RIRS), run by Ankara Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ureteral access sheath insertion rate (time frame: From January 2018 to October 2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07566416, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.