COVID-19 Vaccines and the Development of New LUTS | NCT05582525

Studies
COVID-19 Vaccines and the Development of New LUTS

NCT05582525

Sponsor

The Hashemite University

Status

Completed

Last Update Posted

Oct 17, 2022Actual

Enrollment

341Actual

Phase

Not provided

Conditions

COVID-19 Vaccine Adverse Reaction
Lower Urinary Tract Symptoms

Interventions

Not provided

Countries

Jordan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2022Actual

Primary Completion Date

Apr 1, 2022Actual

Completion Date

Apr 1, 2022Actual

First Submitted Date

Oct 14, 2022

First Submission Date that Met QC Criteria

Oct 14, 2022

First Posted Date

Oct 17, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 14, 2022

Last Update Posted Date

Oct 17, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

341Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
New Lower Urinary Tract Symptoms	Only after having had any COVID -19 vaccine	2-3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Medical Student
Having had a COVID-19 Vaccine

Exclusion Criteria:

None

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Medical students

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jad K AlSmadi, MD	The Hashemite University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Hashemite University		Zarqa		13133	Jordan

IPD Sharing Statement Module

Plan to Share IPD

Description

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.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D059411	Lower Urinary Tract Symptoms

Ancestor Terms

ID	Term
D020924	Urological Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided