Registry of MIUS for Urolithiasis (ReMIUS-U)

Urolithiasis Clinical Trial

— ReMIUS-U  

Official title:

Registry of Minimally Invasive Urology Society for Urolithiasis Patients

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06394908
• Other study ID #: MIUS.2022.001
• Status: Enrolling by invitation
• Start date: May 10, 2023
• Est. completion date: May 2027

Study information

• Verified date: April 2024
• Source: Marmara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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).

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 10000
• Est. completion date: May 2027
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Complication of Surgical Procedure
• Kidney Calculi
• Nephrolithiasis
• Stone Ureter
• Stone, Kidney
• Urinary Calculi
• Urolithiasis

Locations

Country	Name	City	State
Turkey	Marmara University Hospital	Istanbul

Sponsors (12)

Lead Sponsor	Collaborator
Marmara University	Alanya Alaaddin Keykubat University, Baskent University, Cukurova University, Dokuz Eylul University, Gazi University, Hitit University, Koç University, Mugla Sitki Koçman University, Necmettin Erbakan University, Ondokuz Mayis University, Samsun Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

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