Evaluation of the effect of Montelukast on urinary symptoms in children with overactive bladder
Design
Clinical trial with control group, with factorial groups, phase 3, on 60 patients.
Settings and conduct
60 children with bladder hyperactivity, referred to the pediatric clinic of Amirkabir Hospital in Arak, Will be divided into two equal groups of Montelukast and the control group.
In the Montelukast group, 5 mg (one tablet) of Montelukast tablets daily is given to each child for 10 days, along with the classic treatment of hyperactive bladder, and the control group received only the classic treatment for 10 days. At the beginning and end of the study, mothers of children will be asked questions about their urinary status and will be noted on a checklist.
Participants/Inclusion and exclusion criteria
Inclusion condition: Children with bladder hyperactivity, aged 3-17 years, with a history of allergies؛
Condition not to enter: History of allergy to Montelukast drug
Intervention groups
The recipient group of Montelukast and classical medicine
The control group received classical treatment alone
Main outcome variables
Type of intervention; Frequent urination; Frequent incontinence; Frequent urinary urgency
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210212050333N1
Registration date:2021-06-09, 1400/03/19
Registration timing:prospective
Last update:2021-06-09, 1400/03/19
Update count:0
Registration date
2021-06-09, 1400/03/19
Registrant information
Name
Somayeh Abbasi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3277 8434
Email address
m.h1221@mailfa.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-30, 1400/04/09
Expected recruitment end date
2021-07-31, 1400/05/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Montelukast on urinary symptoms in children with bladder hyperactivity
Public title
The effect of Montelukast on bladder hyperactivity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children with bladder hyperactivity 3-17 years old
Exclusion criteria:
History of allergy to Monteluca
Age
From 3 years old to 17 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
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 Committee of Arak University of Medical Sciences
Street address
Shahid Shiroodi St Alam alHuda St.
City
Arak
Province
Markazi
Postal code
3819693345
Approval date
2021-01-23, 1399/11/04
Ethics committee reference number
IR.ARAKMU.REC.1399.310
Health conditions studied
1
Description of health condition studied
Overactive bladder
ICD-10 code
N39.4
ICD-10 code description
Other specified urinary incontinence
Primary outcomes
1
Description
Frequent urination
Timepoint
Frequent urination was measured at the beginning of the study and 10 days after starting Montelukast
Method of measurement
questionnaire
2
Description
Frequent urgency incontinence
Timepoint
Measuring the incidence of urgent incontinence at the beginning of the study and 10 days after starting Montelukast
Method of measurement
questionnaire
3
Description
Frequent urinary urgency
Timepoint
Measure the frequency of urinary urgency at the beginning of the study and 10 days after starting Montelukata
Method of measurement
questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Monte lucast 5 mg tablets, one tablet daily for 10 days, with classic treatment
Category
Treatment - Drugs
2
Description
Control group: receiving classical treatment alone for 10 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amirkabir Hospital
Full name of responsible person
Fateme Dorre
Street address
Shahid Shiroudi St Parstar Sq. Amirkabir Hospital, Arak
City
Arak
Province
Markazi
Postal code
3819691187
Phone
+98 86 3313 4715
Email
Fatemeh-dorre@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Masoumeh Kalantari
Street address
Shahid Shiroodi St Alam alHuda St.
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 6055
Fax
+98 86 3313 3147
Email
info@arakmu.ac.ir
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
Dr. Fatemeh Darreh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Shahid Shiroudi St Parstar Sq Amirkabir Hospital, Arak
City
Arak
Province
Markazi
Postal code
3819691187
Phone
086 33134715-19
Email
Fatemeh-dorre@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Fatemeh Darreh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Shahid Shiroudi St Parstar Sq Amirkabir Hospital, Arak
City
Arak
Province
Markazi
Postal code
3819691187
Phone
086 33134715-19
Email
Fatemeh-dorre@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Somayeh Abbasi
Position
Intern student
Latest degree
A Level or less
Other areas of specialty/work
Pediatrics
Street address
Imam Khomeini St 12 meters from Fatemieh Ansari Alley
City
Arak
Province
Markazi
Postal code
3816195835
Phone
+98 86 3277 8434
Email
m.h1221@mailfa.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available