UrolithiasisReMIUS-UNCT06394908
Registry of MIUS for Urolithiasis (ReMIUS-U)
An observational study of Urolithiasis and Stone, Kidney, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this registry is to collect data on patients who have undergone minimally invasive treatments for urinary system stone disease, including percutaneous nephrolithotomy (PCNL), shock wave lithotripsy (SWL), semi-rigid ureterorenoscopy (URS), and flexible ureterorenoscopy (F-URS). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Urolithiasis, Stone, Kidney, Stone Ureter
- How many people
- 10,000 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 May 2023to May 2030
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who receive urolithiasis treatment without contraindication
Who may be able to join
- To have a medical indication for urolithiasis
- Complete data of treatment and follow-up course
- Patients with consent
- Patients > 18 years-old
- Patients < 18 years-old
Who cannot join
- Missing data
- Patients without consent
- Not to have a medical indication for urolithiasis treatment
- To have a contraindication for urolithiasis treatment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Registry of Minimally Invasive Urology Society for Urolithiasis Patients
The purpose of this registry is to collect data on patients who have undergone minimally invasive treatments for urinary system stone disease, including percutaneous nephrolithotomy (PCNL), shock wave lithotripsy (SWL), semi-rigid ureterorenoscopy (URS), and flexible ureterorenoscopy (F-URS).
Read the detailed description
In this project, the Minimally Invasive Urology Association urolithiasis study group aimed to collect the data of adult and pediatric urinary system stone patients treated with PCNL, SWL, URS, and F-URS in a non-randomized, observational, and prospective manner. The registry was to be conducted multi-center in Turkey.
In this project, Excel files were created and shared via Google Drive with the responsible physicians at the centers to be included in the study. Each parameter was prepared in an explanatory manner and can be readily filled out by physicians familiar with these methods. The ability to examine and modify existing data will be restricted to the worker and the database administrator. Patients' identities will not be revealed in the registry.
The collected data are summarized in three sections under the major headings below;
- Demographics and preoperative information; Patient, disease, and treatment method demographic data, such as age, gender, height, weight, previous diseases, medications used, location, size, and hardness of urinary tract stones, the side of the stone, and the methods used for diagnosis, will be prospectively recorded for patients whose consent was obtained.
- Data during the operation; The duration of the operation as well as the devices and methods utilized will be recorded.
- In the postoperative period, post-treatment findings, such as stone-free status and post-treatment complications, will be documented.
A separate application to the ethics committee will be submitted for each study on the subject that will be created in the future from the multi-center, prospectively recorded data pool and on the subject that will be investigated.
- Keywords
- Prospective studies, Registries, Urolithiasis
- Medical subject headings
- Urolithiasis, Kidney Calculi, Ureterolithiasis
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative durations of each treatment technique (PCNL, SWL, URS, F-URS)
The duration of the operation time
Measured: Operation/procedure day
Operative radiation dosage of each treatment technique (PCNL, SWL, URS, F-URS)
X-ray dosage
Measured: Operation/procedure day
Operative results of each treatment technique (PCNL, SWL, URS, F-URS)
The duration of the laser time
Measured: Operation/procedure day
Postoperative results
Postoperative estimated glomerular filtration rate (CKD Epidemiology Collaboration (CKD-EPI) equation) (mL/min/1.73 m2)
Measured: immediately after procedure
Rate of postoperative complication
Abnormal clinical and laboratory findings that may be seen after surgery and require additional intervention, treatment, or follow-up
Measured: up to 3 months, postoperatively
Follow-up
Follow-up results of patients for recurrence of disease of residual stones, if any reoperation records.
Measured: up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start10 May 2023
- Primary completionMay 2030 (estimated)
- Study completionMay 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for UrolithiasisStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Collaborators
- Samsun Education and Research Hospital, Gazi University, Koç University, Baskent University, Cukurova University, Ondokuz Mayıs University, Muğla Sıtkı Koçman University, Necmettin Erbakan University, Alanya Alaaddin Keykubat University, Dokuz Eylul University, Hitit University
- Responsible party
- Principal investigator, Yiloren Tanidir, Marmara University
- Investigators
- yiloren tanidir, Assoc.Prof, Study chair, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06394908
- Sponsor's protocol ID
- MIUS.2022.001
- Acronym
- ReMIUS-U
- Status last verified
- Aug 2025
- First submitted
- 18 Apr 2024
- Last updated
- 20 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tanidir Y, Ates T, Girgin R, Gulsen M, Kalayci O, Aydin C, Kizgin M, Sen V, Sinirsiz C, Akarken I, Aydin EC, Sener TE, Dorucu D, Ozsoy AF, Goger YE, Akdogan N. Complication profiling in ureteroscopy: A prospective multicenter comparison of the Clavien-Dindo classification and the comprehensive complication index. Urolithiasis. 2026 Sep 19;54(1):155. doi: 10.1007/s00240-026-02056-4.
PubMed 42762250
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry of Minimally Invasive Urology Society for Urolithiasis Patients
- ClinicalTrials.gov ID
- NCT06394908
- Acronym / sponsor ID
- ReMIUS-U / MIUS.2022.001
- Keywords
- Prospective studies, Registries, Urolithiasis
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Collaborators
- Samsun Education and Research Hospital, Gazi University, Koç University, Baskent University, Cukurova University, Ondokuz Mayıs University, Muğla Sıtkı Koçman University, Necmettin Erbakan University, Alanya Alaaddin Keykubat University, Dokuz Eylul University, Hitit University
- Study start
- 10 May 2023 (actual)
- Primary completion
- May 2030 (estimated)
- Study completion
- May 2030 (estimated)
- First posted
- 1 May 2024 (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 purpose of this registry is to collect data on patients who have undergone minimally invasive treatments for urinary system stone disease, including percutaneous nephrolithotomy (PCNL), shock wave lithotripsy (SWL), semi-rigid ureterorenoscopy (URS), and flexible ureterorenoscopy (F-URS).
Detailed description
In this project, the Minimally Invasive Urology Association urolithiasis study group aimed to collect the data of adult and pediatric urinary system stone patients treated with PCNL, SWL, URS, and F-URS in a non-randomized, observational, and prospective manner. The registry was to be conducted multi-center in Turkey.
In this project, Excel files were created and shared via Google Drive with the responsible physicians at the centers to be included in the study. Each parameter was prepared in an explanatory manner and can be readily filled out by physicians familiar with these methods. The ability to examine and modify existing data will be restricted to the worker and the database administrator. Patients' identities will not be revealed in the registry.
The collected data are summarized in three sections under the major headings below;
- Demographics and preoperative information; Patient, disease, and treatment method demographic data, such as age, gender, height, weight, previous diseases, medications used, location, size, and hardness of urinary tract stones, the side of the stone, and the methods used for diagnosis, will be prospectively recorded for patients whose consent was obtained.
- Data during the operation; The duration of the operation as well as the devices and methods utilized will be recorded.
- In the postoperative period, post-treatment findings, such as stone-free status and post-treatment complications, will be documented.
A separate application to the ethics committee will be submitted for each study on the subject that will be created in the future from the multi-center, prospectively recorded data pool and on the subject that will be investigated.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who receive urolithiasis treatment without contraindication
Key inclusion criteria (5 listed)
- To have a medical indication for urolithiasis
- Complete data of treatment and follow-up course
- Patients with consent
- Patients > 18 years-old
- Patients < 18 years-old
Key exclusion criteria (4 listed)
- Missing data
- Patients without consent
- Not to have a medical indication for urolithiasis treatment
- To have a contraindication for urolithiasis treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Operative durations of each treatment technique (PCNL, SWL, URS, F-URS)
Time frame: Operation/procedure day
The duration of the operation time
Operative radiation dosage of each treatment technique (PCNL, SWL, URS, F-URS)
Time frame: Operation/procedure day
X-ray dosage
Operative results of each treatment technique (PCNL, SWL, URS, F-URS)
Time frame: Operation/procedure day
The duration of the laser time
Postoperative results
Time frame: immediately after procedure
Postoperative estimated glomerular filtration rate (CKD Epidemiology Collaboration (CKD-EPI) equation) (mL/min/1.73 m2)
Rate of postoperative complication
Time frame: up to 3 months, postoperatively
Abnormal clinical and laboratory findings that may be seen after surgery and require additional intervention, treatment, or follow-up
Follow-up
Time frame: up to 10 years
Follow-up results of patients for recurrence of disease of residual stones, if any reoperation records.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2025.
- Derived from this study: PubMed 42762250Tanidir Y, Ates T, Girgin R, Gulsen M, Kalayci O, Aydin C, Kizgin M, Sen V, Sinirsiz C, Akarken I, Aydin EC, Sener TE, Dorucu D, Ozsoy AF, Goger YE, Akdogan N. Complication profiling in ureteroscopy: A prospective multicenter comparison of the Clavien-Dindo classification and the comprehensive complication index. Urolithiasis. 2026 Sep 19;54(1):155. doi: 10.1007/s00240-026-02056-4.
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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.
yiloren tanidir, Assoc.Prof study chair
Marmara University
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 Urolithiasis and Stone, Kidney, run by Marmara University 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 5 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 20 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Operative durations of each treatment technique (PCNL, SWL, URS, F-URS) (time frame: Operation/procedure day). The study lists 6 primary outcomes in all. 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 NCT06394908, which also lists 1 linked publication.
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 20 Aug 2025.