Prospective Relationship Between the Rates of Spontaneous Passage of Distal Ureteral Stones and the Distal Lumen

Prospective Observational Evaluation of the Relationship Between the Rates of Spontaneous Passage of Distal Ureteral Stones and the Diameter of the Most Narrow Part of the Distal Ureter

Patients (female, male, or queer) with ureteral stones (smaller than 1 cm at the widest diameter of the stone) without pyonephrosis, urinary sepsis, or untraceable pain will be enrolled into the study. Ureteral width at the smallest area of the ureter (in most cases UV junction) will be noted during regular ultrasound scans. The ratio of ureteral width to the stone diameter will be correlated with the spontaneous stone passage.

Study Overview

• Status: Recruiting
• Conditions: Ureter Stone
• Intervention / Treatment: Procedure: Ultrasound

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Ozer U Cakici, MD, FEBU; Phone Number: +90 541 461 20 51; Email: ozerural@hotmail.com

Study Locations

• Turkey
  • Erzurum, Turkey
    • Recruiting
    • Ataturk University
    • Contact: Fatih Ozkaya, MD; Phone Number: +90 505 943 6892; Email: fatih.ozkaya@atauni.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with ureter stones

Description

Inclusion Criteria:

Ureteral Stone smaller than 1 cm Volunteer to be enrolled

Exclusion Criteria:

Pyonephrosis Urinary Sepsis Untraceable Pain

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Passage Observed; Enrolled patients whose stone and ureter diameters are obtained and their stone passage was successful during the follow-up.	Procedure: Ultrasound; Enrolled patients underwent ultrasound scan of kidneys, ureters, and the bladder.
Passage Not Observed; Enrolled patients whose stone and ureter diameters are obtained and their stone passage was not successful during the follow-up.	Procedure: Ultrasound; Enrolled patients underwent ultrasound scan of kidneys, ureters, and the bladder.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Passage	The number of recruited individuals whose ureteral stones are found to be passed by their report and it is confirmed by ultrasound	3 months

Collaborators and Investigators

• Sponsor: Hiram's Healthcare and Education Company
• Collaborators: Ataturk University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Anticipated): January 1, 2023
• Study Completion (Anticipated): January 1, 2023

Study Registration Dates

• First Submitted: November 16, 2021
• First Submitted That Met QC Criteria: June 9, 2022
• First Posted (Actual): June 13, 2022

Study Record Updates

• Last Update Posted (Actual): June 13, 2022
• Last Update Submitted That Met QC Criteria: June 9, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Pathological Conditions, Anatomical; Ureteral Diseases; Urolithiasis; Urinary Calculi; Calculi; Ureteral Calculi; Ureterolithiasis
• Other Study ID Numbers: B.30.2.ATA.0.01.00

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

IPD Plan Description

IPD will be shared among the following criteria:

• As allowed to the degree which is allowed by the enrolled patients.
• As required by the researchers

• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No