Registry of MIUS for Urolithiasis (ReMIUS-U)

Status Enrolling by invitation

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).

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06394908
Study type	Observational [Patient Registry]
Source	Marmara University
Contact
Status	Enrolling by invitation
Phase
Start date	May 10, 2023
Completion date	May 2027

View Details

See also
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Terminated	`NCT01736358` - The Use of Intranasal Ketoralac for Pain Management (Sprix)	Phase 4
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms