The Effect of the COVID-19 on Patient Preferences and Decision Making for Obstructive Urinary Stone Interventions

The Effect of the COVID-19 Pandemic on Patient Preferences and Decision Making for Obstructive Urinary Stone Interventions

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.

Study Overview

• Status: Recruiting
• Conditions: Covid19; Urinary Calculi; Urinary Stone
• Intervention / Treatment: Behavioral: COVID-19 Pandemic

Detailed Description

The transformative impact of the COVID-19 pandemic on healthcare use remains an open question. At the onset of the pandemic, policies to limit transmission were adopted, including stay-at-home decisions, social distancing, and postponing elective surgery. Such policies have contributed to reduced emergency room admissions, increased concern about COVID-19, and hospital systems have had to prioritize emergency intervention.

Obstructive urolithiasis is a clinical condition that usually causes severe flank pain and causes emergency admission. It is still unclear how the epidemic impairs the treatment pathways of the obstructive urolithiasis that contributes to the emergency room visit. Treatment options range from observation and medical expulsive therapy to operative interventions such as extracorporeal shock wave lithotripsy, ureteroscopy and percutaneous nephrolithotomy. Patient preference, stone characteristics and comorbidities are of great importance in decision making. However, since obstructive ureteral stones that cannot be resolved spontaneously can cause irreversible renal parenchymal damage and obstructive pyelonephritis in a short time, the option of operation is always prioritized.

Patient perspectives on how COVID-19 is changing healthcare use and decision-making still remain unclear. In our study, the investigators plan to record patient treatment preferences by explaining in detail how and where treatment options will be applied, success and complication rates for patients diagnosed with obstructive urolithiasis and suitable for intervention in the outpatient clinic. In addition, when evaluating patient preferences, the investigators foresee to determine how the COVID-19 pandemic process has changed compared to before. It is planned that our study will have a patient-centered approach with detailed oral and written information in outpatient clinic conditions.

• Study Type: Observational
• Enrollment (Anticipated): 158

Contacts and Locations

Study Locations

• Turkey
  • Altindag
    • Ankara, Altindag, Turkey, 06230
      • Recruiting
      • Ankara Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

• Obstructive Urinary Stone

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
COVID-19 Urinary Stone; Patients diagnosed with obstructive urinary stones in the COVID-19 period	Behavioral: COVID-19 Pandemic; 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
PreCOVID-19 Urinary Stone; Patients diagnosed with obstructive urinary stones in the preCOVID-19 period	Behavioral: COVID-19 Pandemic; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rates of interventions preferred by patients	Rates of interventions preferred by patients for obstructive urinary stones	6 months

Collaborators and Investigators

• Sponsor: Ankara Training and Research Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Anticipated): May 1, 2022
• Study Completion (Anticipated): August 1, 2022

Study Registration Dates

• First Submitted: June 10, 2021
• First Submitted That Met QC Criteria: June 10, 2021
• First Posted (Actual): June 14, 2021

Study Record Updates

• Last Update Posted (Actual): March 2, 2022
• Last Update Submitted That Met QC Criteria: February 28, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Covid19; Urinary stone; Obstructive stone; Stone surgery
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Urologic Diseases; Pathological Conditions, Anatomical; COVID-19; Urinary Calculi; Urolithiasis; Calculi
• Other Study ID Numbers: COVIDUS2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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