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Enrolling by Invitation

NCT Number: NCT06394908

Registry of MIUS for Urolithiasis (ReMIUS-U)

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).

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Key information

Conditions

Urolithiasis Calculi Complication of Surgical Procedure Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Calculi Kidney Diseases Male Urogenital Diseases Nephrolithiasis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Stone Ureter Stone, Kidney Ureteral Diseases Ureterolithiasis Urinary Calculi Urogenital Diseases Urologic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Marmara University Hospital

Istanbul, 34890, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Operative durations of each treatment technique (PCNL, SWL, URS, F-URS)

    Time frame: Operation/procedure day

    The duration of the operation time

  2. Operative radiation dosage of each treatment technique (PCNL, SWL, URS, F-URS)

    Time frame: Operation/procedure day

    X-ray dosage

  3. Operative results of each treatment technique (PCNL, SWL, URS, F-URS)

    Time frame: Operation/procedure day

    The duration of the laser time

  4. Postoperative results

    Time frame: immediately after procedure

    Postoperative estimated glomerular filtration rate (CKD Epidemiology Collaboration (CKD-EPI) equation) (mL/min/1.73 m2)

  5. 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

  6. Follow-up

    Time frame: up to 10 years

    Follow-up results of patients for recurrence of disease of residual stones, if any reoperation records.

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Collaborators

  • Alanya Alaaddin Keykubat University
  • Baskent University
  • Cukurova University
  • Dokuz Eylul University
  • Gazi University
  • Hitit University
  • Koç University
  • Muğla Sıtkı Koçman University
  • Necmettin Erbakan University
  • Ondokuz Mayıs University
  • Samsun Education and Research Hospital

Registry information

Official study title

Registry of Minimally Invasive Urology Society for Urolithiasis Patients

Acronym: ReMIUS-U

Important dates

Study start
2023
Primary completion
2030
Study completion
2030
First posted
May 1, 2024
Registry last updated
Aug 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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