Registry of MIUS for Urolithiasis (ReMIUS-U) (ReMIUS-U)

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).

Study Overview

• Status: Enrolling by invitation
• Conditions: Complication of Surgical Procedure; Urolithiasis; Stone Ureter; Stone, Kidney

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;

1. 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.
2. Data during the operation; The duration of the operation as well as the devices and methods utilized will be recorded.
3. 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 Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34890
    • Marmara University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who receive urolithiasis treatment without contraindication

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Missing data
• Patients without consent
• Not to have a medical indication for urolithiasis treatment
• To have a contraindication for urolithiasis treatment

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative durations of each treatment technique (PCNL, SWL, URS, F-URS)	The duration of the operation time	Operation/procedure day
Operative radiation dosage of each treatment technique (PCNL, SWL, URS, F-URS)	X-ray dosage	Operation/procedure day
Operative results of each treatment technique (PCNL, SWL, URS, F-URS)	The duration of the laser time	Operation/procedure day
Postoperative results	Postoperative estimated glomerular filtration rate (CKD Epidemiology Collaboration (CKD-EPI) equation) (mL/min/1.73 m2)	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	up to 3 months, postoperatively
Follow-up	Follow-up results of patients for recurrence of disease of residual stones, if any reoperation records.	up to 10 years

Collaborators and Investigators

• Sponsor: Marmara University
• Collaborators: Cukurova University; Gazi University; Baskent University; Muğla Sıtkı Koçman University; Koç University; Dokuz Eylul University; Necmettin Erbakan University; Ondokuz Mayıs University; Hitit University; Samsun Education and Research Hospital; Alanya Alaaddin Keykubat University
• Investigators: Study Chair: yiloren tanidir, Assoc.Prof, Marmara University

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2023
• Primary Completion (Estimated): May 1, 2030
• Study Completion (Estimated): May 1, 2030

Study Registration Dates

• First Submitted: April 18, 2024
• First Submitted That Met QC Criteria: April 28, 2024
• First Posted (Actual): May 1, 2024

Study Record Updates

• Last Update Posted (Actual): August 20, 2025
• Last Update Submitted That Met QC Criteria: August 14, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Urolithiasis; Prospective studies; Registries
• 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; Kidney Calculi; Nephrolithiasis; Urinary Calculi; Urolithiasis
• Other Study ID Numbers: MIUS.2022.001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No