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

Sponsor

Hiram's Healthcare and Education Company (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05416502

Collaborator

Ataturk University (Other)

1,000

Enrollment

Location

Anticipated Duration (Months)

41.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Ureter Stone	Procedure: Ultrasound

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 1, 2021

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Jan 1, 2023

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Passage [3 months]
The number of recruited individuals whose ureteral stones are found to be passed by their report and it is confirmed by ultrasound

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Ureteral Stone smaller than 1 cm Volunteer to be enrolled

Exclusion Criteria:

Pyonephrosis Urinary Sepsis Untraceable Pain

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ataturk University	Erzurum		Turkey

Sponsors and Collaborators

Hiram's Healthcare and Education Company
Ataturk University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hiram's Healthcare and Education Company

ClinicalTrials.gov Identifier:

NCT05416502

Other Study ID Numbers:

B.30.2.ATA.0.01.00

First Posted:

Jun 13, 2022

Last Update Posted:

Jun 13, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Ureteral Calculi

Ureterolithiasis

Study Results

No Results Posted as of Jun 13, 2022