Evaluation of Montelukast effect on children with bladder pain syndrome
Design
A randomized clinical trial with control with out blinding,phase 2 on 64 patient.
Randomization is performed by using quadruple blocks which is produced by statistical software
Settings and conduct
children with bladder pain syndrome and entry criteria are added to the study after getting consent with blocking randomization method in Amirkabir hospital of Arak city.Diagnosis of the disease is confirmed by getting history,checking urine analysis and culture and also sonography to rule out other medical conditions.children with Bps are divided into two groups:(Montelukast receiving) and (control)group.In Montelukast receiving group Monteukast and Oxybutinin are prescribed for each child for 14days and in control group only classic treatment(Oxybutinin) is prescribed for 14days.In the beginning and end of the study the symptoms are checked and added to the prepared checklists.
Participants/Inclusion and exclusion criteria
Entry criteria:All 3-18 year old children with bladder pain syndrome and allergy history who were referred to Amirkabir hospital pediatric clinic and were admitted to Amirkabir hospital wards
Exit criteria:Allergy history to Montelukast
Intervention groups
In Montelukast receiving group Monteukast(chewable tab 5mg) and Oxybutinin(tab 5 mg)are prescribed for each child for 14days and in control group only classic treatment(Oxybutinin) is prescribed.
Montelukast :5mg in 3-15 y children,10mg in children who are older than15 daily
Oxybutinin: 0.2mg/kg/dose twice a day in children who are under 5 years old and 5 mg twice a day in children who are older than 5
Main outcome variables
Comparison of frequency, nocturia,urgency ,incontinency and bladder pain severity before and after intervention in Montelukast receiving group and in control group among children with pain bladder syndrome
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210628051728N1
Registration date:2021-07-08, 1400/04/17
Registration timing:prospective
Last update:2021-07-08, 1400/04/17
Update count:0
Registration date
2021-07-08, 1400/04/17
Registrant information
Name
Faezeh Akbarzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3313 5075
Email address
faezeakbarzadeh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-02, 1400/05/11
Expected recruitment end date
2021-10-22, 1400/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of Montelukast on urinary symptoms in children with bladder pain syndrome
Public title
The effect of Montelukast on symptoms of children with bladder pain syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All 3-18 year old children with bladder pain syndrome who were referred to Amirkabir hospital pediatric clinic of Arak city
All 3-18 year old children with bladder pain syndrome who were admitted to Amirkabir hospital ward of Arak city
Allergy history
Exclusion criteria:
Allergy history to Montelukast
Age
From 3 years old to 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
For dividing patients into two groups block randomization method will be used.This method is used for making balance in allocated cases.The epidemiologist will create randomization sequences by using quadruple blocks(Two cases from control group and two cases from case group) that are produced by the assist of sealed envelope online site and will allocate patients to two groups.As soon as a patient enters the project its status will be determined so the concealment process will be guaranteed.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics commitee of Arak University of Medical Sciences
Street address
Arak university of medical sciences,Payambare Azam university complex,Basij Square,Sardasht,Arak
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2021-06-12, 1400/03/22
Ethics committee reference number
IR.ARAKMU.REC.1400.055
Health conditions studied
1
Description of health condition studied
Bladder pain syndrome
ICD-10 code
R39.89
ICD-10 code description
Other symptoms and signs involving the genitourinary system
Primary outcomes
1
Description
decrease nocturia
Timepoint
days0-14
Method of measurement
questionnaire(numbers)
2
Description
Alleviate bladder pain
Timepoint
days0-14
Method of measurement
questionnaire(mild/moderate/severe)
3
Description
Decrease urinary Incontinency
Timepoint
days 0-14
Method of measurement
questionnaire(numbers)
4
Description
Decrease urinary urgency
Timepoint
days 0-14
Method of measurement
questionnaire(numbers)
5
Description
Decrease urinary frequency
Timepoint
days 0-14
Method of measurement
questionnaire(numbers)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Montelukast chewable tablet 5mg in 3-15 year children,10mg in older than 15 year children daily for 14days.This tablet is made in Iran,Dr Abidi pharmaceutical company.Classic treatment consists of Oxybutinin 5mg tablets which is prescribed 0.2mg/kg/dose twice a day in children younger than 5 and 5mg twice a day in older than 5 year old children.It is made in Iran,Iran Daru pharmaceutical company.
Category
Treatment - Drugs
2
Description
Control group: Classic treatment consists of Oxybutinin 5mg tablets which is prescribed 0.2mg/kg/dose twice a day in children younger than 5 and 5mg twice a day in older than 5 year old children.It is made in Iran,Iran Daru pharmaceutical company.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amirkabir hospital
Full name of responsible person
Dr Ali Arjmand,Dr Fatemeh Dorreh,Faezeh Akbarzadeh
Arak university of medical sciences,Payambare Azam university complex,Basij square,Sardasht,Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 6055
Email
alikamaliir@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Faezeh Akbarzadeh
Position
Intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Arak university of medical sciences,Payambare Azam university complex,Basij Square,Sardasht,Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 6055
Email
faezeakbarzadeh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Faezeh Akbarzadeh
Position
Intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Arak university of medical sciences,Payambare Azam university complex,Basij Square,Sardasht,Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3313 6055
Email
faezeakbarzadeh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Faezeh Akbarzadeh
Position
Medical Intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Arak university of medical sciences,Payambare Azam university complex,Basij Square,Sardasht,Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 6055
Email
faezeakbarzadeh@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All the individual data of participants
When the data will become available and for how long
The access period starts immediately after publishing the results
To whom data/document is available
The information will be available for any researcher.
Under which criteria data/document could be used
There is no limitation.
From where data/document is obtainable
Faezeh Akbarzadeh via faezeakbarzadeh@yahoo.com / Dr.Ali Arjmand via aliarjmand1@yahoo.com /Dr.Fatemeh Dorreh via fatemeh_dorre@yahoo.com/ Dr.Parsa Yousefi via parsayousefichaijan@yahoo.com
What processes are involved for a request to access data/document
The applicant must send his request via email while introducing himself and his reason for information access .Then the data will be sent back by email.