NCT04924790

Brief Summary

In this study, the investigators aim to evaluate the intervention preferences of patients with obstructive urinary stones who are suitable for operation during the COVID-19 pandemic. The secondary aim is to compare and evaluate the preferences compared to the pre-pandemic period and to gain a perspective on how the decision-making process has changed from the patient's point of view. Thus, by trying to understand how the COVID-19 epidemic affects the treatment choice decisions of patients, the investigators aim to determine how the state of anxiety changes these preferences.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
158

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 10, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 14, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

March 2, 2022

Status Verified

February 1, 2022

Enrollment Period

8 months

First QC Date

June 10, 2021

Last Update Submit

February 28, 2022

Conditions

Urinary StoneUrinary CalculiCovid19

Keywords

Urinary stoneObstructive stoneCovid19Stone surgery

Outcome Measures

Primary Outcomes (1)

  • Rates of interventions preferred by patients

    Rates of interventions preferred by patients for obstructive urinary stones

    6 months

Study Arms (2)

COVID-19 Urinary Stone

Patients diagnosed with obstructive urinary stones in the COVID-19 period

Behavioral: COVID-19 Pandemic

PreCOVID-19 Urinary Stone

Patients diagnosed with obstructive urinary stones in the preCOVID-19 period

Behavioral: COVID-19 Pandemic

Interventions

COVID-19 PandemicBEHAVIORAL

Comparison of the intervention preferences of patients diagnosed with obstructive urinary stones in the urology clinic and recommended for intervention during and before COVID-19

COVID-19 Urinary StonePreCOVID-19 Urinary Stone

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients diagnosed with obstructive urinary stones in the urology clinic and recommended intervention

You may qualify if:

  • Obstructive Urinary Stone

You may not qualify if:

  • Previous operation for urinary stone
  • Presence of bladder stone
  • Presence of stent in the ureter
  • Previous radiotherapy to the pelvic and abdominal region
  • Pregnancy
  • Neurological disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Training and Research Hospital

Ankara, Altindag, 06230, Turkey (Türkiye)

RECRUITING

Related Publications (3)

  • Jiang T, Osadchiy V, Weinberger JM, Zheng MH, Owen MH, Leonard SA, Mills JN, Kachroo N, Eleswarapu SV. Impact of the COVID-19 Pandemic on Patient Preferences and Decision Making for Symptomatic Urolithiasis. J Endourol. 2021 Aug;35(8):1250-1256. doi: 10.1089/end.2020.1141. Epub 2021 Mar 4.

    PMID: 33478351BACKGROUND

  • Campi R, Tellini R, Grosso AA, Amparore D, Mari A, Viola L, Cocci A, Polverino P, Checcucci E, Alessio P, Fiori C, Minervini A, Carini M, Porpiglia F, Serni S. Deferring Elective Urologic Surgery During the COVID-19 Pandemic: The Patients' Perspective. Urology. 2021 Jan;147:21-26. doi: 10.1016/j.urology.2020.09.015. Epub 2020 Sep 24.

    PMID: 32979378BACKGROUND

  • Lee EH, Kim SH, Shin JH, Park SB, Chi BH, Hwang JH. Effects on renal outcome of concomitant acute pyelonephritis, acute kidney injury and obstruction duration in obstructive uropathy by urolithiasis: a retrospective cohort study. BMJ Open. 2019 Nov 3;9(11):e030438. doi: 10.1136/bmjopen-2019-030438.

    PMID: 31685503BACKGROUND

MeSH Terms

Conditions

Urinary CalculiCOVID-19

Interventions

Pandemic Preparedness

Condition Hierarchy (Ancestors)

UrolithiasisUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Disaster PlanningDisastersEnvironmentEnvironment and Public HealthCommunicable Disease ControlPublic Health PracticePublic Health

Study Officials

  • Ali Kaan Yildiz

    Ankara Training and Resarch Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ali Kaan Yildiz

CONTACT

+90 554 773 16 96alikaanyildiz@gmail.com

Esra Gulen Yildiz

CONTACT

+90 506 877 47 09esragln90@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 10, 2021

First Posted

June 14, 2021

Study Start

September 1, 2021

Primary Completion

May 1, 2022

Study Completion

August 1, 2022

Last Updated

March 2, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)