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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04924790
• Other study ID #: COVIDUS2021
• Status: Recruiting
• Start date: September 1, 2021
• Est. completion date: August 1, 2022

Study information

• Verified date: February 2022
• Source: Ankara Training and Research Hospital
• Contact: Ali Kaan Yildiz
• Phone: +90 554 773 16 96
• Email: alikaanyildiz[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 158
• Est. completion date: August 1, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Calculi
• COVID-19
• Covid19
• Urinary Calculi
• Urinary Stone
• Urolithiasis

Intervention

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

Locations

Country	Name	City	State
Turkey	Ankara Training and Research Hospital	Ankara	Altindag

Sponsors (1)

Lead Sponsor	Collaborator
Ankara Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rates of interventions preferred by patients	Rates of interventions preferred by patients for obstructive urinary stones	6 months