COVID-19 Vaccine Adverse ReactionNCT05582525
COVID-19 Vaccines and the Development of New LUTS
An observational study of COVID-19 Vaccine Adverse Reaction and Lower Urinary Tract Symptoms, run by The Hashemite University at 1 site in Jordan.
Trial summary
This study was conducted to check whether coronavirus disease 2019 (COVID) vaccines have a relationship with LUTS or not in a healthy and mostly medically free population. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Vaccine Adverse Reaction, Lower Urinary Tract Symptoms
- How many people
- 341 participants
- Where
- 1 siteJordan
- Study dates
- 1 Feb 2022to 1 Apr 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Medical students
Who may be able to join
- Medical Student
- Having had a COVID-19 Vaccine
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relationship Between the Coronavirus 2019 Disease (COVID-19) Vaccines and the Development of New Lower Urinary Tract Symptoms: A Cross-sectional Study on Medical Students.
This study was conducted to check whether coronavirus disease 2019 (COVID) vaccines have a relationship with LUTS or not in a healthy and mostly medically free population.
- Keywords
- COVID-19 Vaccines, LUTS, Medical students
- Medical subject headings
- Lower Urinary Tract Symptoms
What is being measured
The primary outcome is the main question the study is designed to answer.
New Lower Urinary Tract Symptoms
Only after having had any COVID -19 vaccine
Measured: 2-3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2022
- Study start1 Feb 2022
- Primary completion1 Apr 2022
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 Vaccine Adverse ReactionStudies 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
- Retrospective
- Enrolment
- 341 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hashemite University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jad Khaled AlSmadi, The Hashemite University
- Investigators
- Jad K AlSmadi, MD, Principal investigator, The Hashemite University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05582525
- Sponsor's protocol ID
- 24/6/2021/2022
- Status last verified
- Oct 2022
- First submitted
- 14 Oct 2022
- Last updated
- 17 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data are going to be kept safe on the internet-based questionnaire website. Only the study team will be able to see those information.
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between the Coronavirus 2019 Disease (COVID-19) Vaccines and the Development of New Lower Urinary Tract Symptoms: A Cross-sectional Study on Medical Students.
- ClinicalTrials.gov ID
- NCT05582525
- Acronym / sponsor ID
- 24/6/2021/2022
- Keywords
- COVID-19 Vaccines, LUTS, Medical students
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 341 participants (actual)
- Lead sponsor
- The Hashemite UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 17 Oct 2022 (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.
This study was conducted to check whether coronavirus disease 2019 (COVID) vaccines have a relationship with LUTS or not in a healthy and mostly medically free population.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Medical students
Key inclusion criteria (2 listed)
- Medical Student
- Having had a COVID-19 Vaccine
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
New Lower Urinary Tract Symptoms
Time frame: 2-3 months
Only after having had any COVID -19 vaccine
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2022.
- Individual participant dataSharing planned: No. The data are going to be kept safe on the internet-based questionnaire website. Only the study team will be able to see those information.
Related trials for COVID-19 Vaccine Adverse Reaction
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Effect of Metabolic Modulation on a Post-acute COVID-19 Vaccination Syndrome (PACVS) Cohort
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COVID-19 Vaccines Safety Tracking (CoVaST)
Adverse Reaction to Vaccine, COVID19 Vaccine
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.
Jad K AlSmadi, MD principal investigator
The Hashemite University
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 COVID-19 Vaccine Adverse Reaction and Lower Urinary Tract Symptoms, run by The Hashemite University at 1 site in Jordan.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 17 Oct 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 Jordan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
New Lower Urinary Tract Symptoms (time frame: 2-3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Oct 2022.