Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202212893434875 Date of Approval: 21/12/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Lower urinary tract symptoms in adults post COVID-19 infection
Official scientific title Lower urinary tract dysfunction in adults after COVID-19, a case series study
Brief summary describing the background and objectives of the trial LUTD (eg, incomplete bladder emptying, urinary retention) can be prominent sometime after the diagnosis of COVID-19. Also they conclude that it is difficult to comment on whether post-COVID-19 urinary retention has psychogenic or neurogenic origins, these factors should also be considered in the differential diagnosis. The aim of this study is to detect any abnormalities in the lower urinary tract function after COVID-19 in adults.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations,Urological and Genital Diseases
Sub-Disease(s) or condition(s) being studied post covid-19 affection of lower urinary tract
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 15/09/2022
Actual trial start date 12/10/2022
Anticipated date of last follow up 31/01/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
1554 the local ethics committee of the Quality Education Assurance Unit, Al-Azhar Faculty of Medicine, Nasr City, Cairo, Egypt
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study Non-randomised Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Urodynamic study will be done for patients had lower urinary tract post covid19 infection none none complete Urodynamic study including: 1-filling cystometry 2- pressure flow study 30
Control Group we have not control group none none no intervention 0 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Age group between 20 to 40 years • Positive COVID-19 in the last three to six months • No any lower urinary tract symptoms before COVID-19 infection • Children and old age • Patients with lower urinary tract symptoms before COVID-19 infection • Past history of neurological lesions • Past history of urethral stricture or urethral trauma • Diabetic neuropathy or uncontrolled diabetes. Adult: 19 Year-44 Year 20 Year(s) 40 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 12/10/2022 FMG IRB
Ethics Committee Address
Street address City Postal code Country
Nasr City cairo 11765 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome there are lower urinary tract dysfunction eg, incomplete bladder emptying, urinary retention, can be prominent sometime after the diagnosis of COVID-19 in some patients post covid-19 infection. 3-6 months post covid-19 infection.
Secondary Outcome yet not known until finishing the study 3-6 months post covid-19 infection
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Al Zahraa University Hospital The Greek Hospital street, Sarayat, Abbasiya, cairo 11535 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
principal investigator The Greek Hospital street, Sarayat, Abbasiya Cairo 11535 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Basem abdallah fathy mohammed Alferdoos buildings, Nasr City, Building 7 cairo 11765 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator basem hara dr.basemhara@hotmail.com +201004868961 nasr city
City Postal code Country Position/Affiliation
Cairo 11765 Egypt lectrurer of urology al azhar univeristy
Role Name Email Phone Street address
Public Enquiries ahmed elgammal aelgammal36@gmail.com +201000906335 nasr city
City Postal code Country Position/Affiliation
cairo 11765 Egypt lectrurer of urology faculty of medicine al azhar univeristy
Role Name Email Phone Street address
Scientific Enquiries khaled sabry doctorkhaled1960@gmail.com +201005118135 rehab city
City Postal code Country Position/Affiliation
cairo 11841 Egypt proffesor of urology faculty of medicine al azhar univeristy
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The dataset of the current study (individual deidentified participant data ) will be available from the corresponding author upon reasonable request and will be shared with other researchers if needed by direct contact with the corresponding author. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months available from the corresponding author upon reasonable request
URL Results Available Results Summary Result Posting Date First Journal Publication Date
sending email No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information