Urinary StoneNCT04924790
The Effect of the COVID-19 on Patient Preferences and Decision Making for Obstructive Urinary Stone Interventions
An observational study of Urinary Stone and Urinary Calculi, run by Ankara Training and Research Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Urinary Stone, Urinary Calculi, Covid19
- What is being tested?
- COVID-19 Pandemic
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 158 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2021to 1 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with obstructive urinary stones in the urology clinic and recommended intervention
Who may be able to join
- Obstructive Urinary Stone
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Training and Research Hospital
Ankara, Altindag, 06230
Ali Kaan Yildiz, +90 554 773 16 96, alikaanyildiz@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Urinary Stone, Urinary Calculi, Covid19
- Being tested
- COVID-19 Pandemic
- Keywords
- Urinary stone, Obstructive stone, Covid19, Stone surgery
- Medical subject headings
- Urinary Calculi, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 PandemicBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 Urinary Stone | Patients diagnosed with obstructive urinary stones in the COVID-19 period Receives: Behavioral: COVID-19 Pandemic | |
| PreCOVID-19 Urinary Stone | Patients diagnosed with obstructive urinary stones in the preCOVID-19 period Receives: Behavioral: COVID-19 Pandemic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of interventions preferred by patients
Rates of interventions preferred by patients for obstructive urinary stones
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2021
- Study start1 Sep 2021
- Primary completion1 May 2022 (estimated)
- Study completion1 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Urinary StoneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 158 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Kaan Yildiz, Ankara Training and Research Hospital
- Investigators
- Ali Kaan Yildiz, Principal investigator, Ankara Training and Resarch Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04924790
- Sponsor's protocol ID
- COVIDUS2021
- Status last verified
- Feb 2022
- First submitted
- 10 Jun 2021
- Last updated
- 2 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 33478351Campi 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.
PubMed 32979378Lee 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.
PubMed 31685503
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the COVID-19 Pandemic on Patient Preferences and Decision Making for Obstructive Urinary Stone Interventions
- ClinicalTrials.gov ID
- NCT04924790
- Acronym / sponsor ID
- COVIDUS2021
- Conditions
- Urinary Stone, Urinary Calculi, Covid19
- Keywords
- Urinary stone, Obstructive stone, Covid19, Stone surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- Ankara Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 May 2022 (estimated)
- Study completion
- 1 Aug 2022 (estimated)
- First posted
- 14 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVID-19 Urinary Stone | – | Behavioral: COVID-19 PandemicPatients diagnosed with obstructive urinary stones in the COVID-19 period |
| PreCOVID-19 Urinary Stone | – | Behavioral: COVID-19 PandemicPatients diagnosed with obstructive urinary stones in the preCOVID-19 period |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with obstructive urinary stones in the urology clinic and recommended intervention
Key inclusion criteria (1 listed)
- Obstructive Urinary Stone
Key exclusion criteria (6 listed)
- Previous operation for urinary stone
- Presence of bladder stone
- Presence of stent in the ureter
- Previous radiotherapy to the pelvic and abdominal region
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVID-19 PandemicComparison of the intervention preferences of patients diagnosed with obstructive urinary stones in the urology clinic and recommended for intervention during and before COVID-19 | Behavioural | COVID-19 Urinary Stone, PreCOVID-19 Urinary Stone |
Primary outcome
Rates of interventions preferred by patients
Time frame: 6 months
Rates of interventions preferred by patients for obstructive urinary stones
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- Background: PubMed 33478351Jiang 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.
- Background: PubMed 32979378Campi 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.
- Background: PubMed 31685503Lee 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.
- Individual participant dataSharing planned: No
Related trials for Urinary Stone
Not yet recruitingPhase 4
A Study on the Efficacy and Safety of Ningmitai Capsules in Treating Patients With Upper Urinary Tract Stones After Extracorporeal Shock Wave Lithotripsy
Calculus of Upper Urinary Tract
Enrolling by invitationObservational study
Renal Structural and Functional Alterations Following Repeated Ureteroscopic Procedures: An Exploratory Multimodal Imaging Study
Urolithiasis, Intrarenal Pressure
RecruitingObservational study
Stone Clearance With Aspiration vs Other Technologies: a Real-world Evidence Study
Urolithiasis, Stones, Kidney
Not yet recruiting
Intertransverse Process Block Versus Erector Spinae Plane Block for Postoperative Analgesia After Percutaneous Nephrolithotomy
Kidney Stones, Urolithiasis, Hypocitraturia, Pain, Postoperative
Not yet recruiting
Comparison of Smart Pressure-Controlled Flexible Ureteroscopy and Flexible Suction Ureteral Access Sheath-Assisted Flexible Ureteroscopy for 2-3 cm Renal Stones
Kidney Stones
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ali Kaan Yildiz principal investigator
Ankara Training and Resarch Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Stone and Urinary Calculi, run by Ankara Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ali Kaan Yildiz (+90 554 773 16 96, alikaanyildiz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of interventions preferred by patients (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04924790, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2022.