Determination of effects of Ritalin on giggle incontinence in children referring to Dr Sheikh hospital
Design
In this study, all patients with giggle incontinence who refer to Nephrology Clinic, after being informed and acquisition of consent, will be included in the study.
Settings and conduct
Giggle incontinence is a type of incontinence in children that appears in the form of a little and sudden wetness which is unpredictable and is determined by unintentional depletion of bladder followed by giggling with normal function of bladder at other hours. This study is going to be carried out in Dr.Sheikh Hospital of Mashhad. There will be thorough neural and physical examination and assessment for all children. No blinding is done in the study. Finally after a month of drug use, patients will be evaluated from a medical response point of view. Medical response is then divided to 3 levels as following: 1-no response 2- relative response as reduction of incontinence numbers to half and 3- complete improvement.
Participants/Inclusion and exclusion criteria
All patients with giggle incontinence will be included in the study and children with neurologic urinary disorders, congenital anomalies and obstruction issues will be excluded.
Intervention groups
Intervention group: Patients are prescribed 0.2 milligram of Ritalin daily for one moth. It is recommended that the drug be given to children before going to school.
Control group: Patients will be given Oxybutynin drug with dose of 0.1 milligram per kilogram. After a month, patients will be evaluated.
Main outcome variables
Rate of control and improvement of incontinence after use of Ritalin
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20111024007892N7
Registration date:2017-12-29, 1396/10/08
Registration timing:retrospective
Last update:2017-12-29, 1396/10/08
Update count:0
Registration date
2017-12-29, 1396/10/08
Registrant information
Name
Anoosh Azarfar
Name of organization / entity
Mashhad University of Medical Sciences, Faculty of Nursing and Midwifery
Country
Iran (Islamic Republic of)
Phone
+98 51 1606 1227
Email address
azarfara@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2014-11-19, 1393/08/28
Expected recruitment end date
2015-11-19, 1394/08/28
Actual recruitment start date
2014-11-19, 1393/08/28
Actual recruitment end date
2016-11-09, 1395/08/19
Trial completion date
empty
Scientific title
Investigation of effects of Ritalin on giggle incontinence in children referring to Dr Sheikh hospital
Public title
Investigation of effects of Ritalin on giggle incontinence in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
older than five years old patients with giggle incontinence
completion of informed consent form
no existence of urological diseases
Exclusion criteria:
patients with neurogenic bladder
congenital disorders of urinary system
urinary tract obstruction
neurological disorders such as myelomenoncule
unwillingness to participate in the study
Age
From 6 years old to 12 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
20
Actual sample size reached:
15
Randomization (investigator's opinion)
Randomized
Randomization description
Using table of random numbers and envelope method, patients will be divided to two groups
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
No blinding is done.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Taheri Ave, Tohid Square, Dr. Sheikh Hospital,
City
Mashhad
Province
Razavi Khorasan
Postal code
1358- 91735
Approval date
2014-11-19, 1393/08/28
Ethics committee reference number
IR.MUMS.REC.1394.631
Health conditions studied
1
Description of health condition studied
urinary incontinence
ICD-10 code
R39.81
ICD-10 code description
Functional urinary incontinence
Primary outcomes
1
Description
Rate of control and improvement of incontinence after use of Ritalin
Timepoint
A month after use of Ritalin
Method of measurement
Medical response is divided to 3 levels as following: 1-no response 2- relative response as reduction of incontinence numbers to half and 3- complete improvement
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients are prescribed 0.2 milligram of Ritalin daily for one moth. It is recommended that the drug be given to children before going to school
Category
Treatment - Drugs
2
Description
Control group: Patients will be given Oxybutynin drug with dose of 0.1 milligram per kilogram for one month.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mashhad Dr.Sheikh Hospital
Full name of responsible person
Anoosh Azarfar
Street address
Taheri Ave, Tohid Square, Dr. Sheikh Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
1358- 91735
Phone
+98 51 3726 9021
Email
azarfara@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
91778-99191
Phone
+98 51 3841 1538
Email
ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Anoosh Azarfar
Position
Associated professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Taheri Ave, Tohid Square, Dr. Sheikh Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
1358- 91735
Phone
+98 51 3726 9021
Email
azarfara@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Anoosh Azarfar
Position
Associated professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Taheri Ave, Tohid Square, Dr. Sheikh Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
1358- 91735
Phone
+98 51 3726 9021
Email
azarfara@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Anoosh Azarfar
Position
Associated professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Taheri Ave, Tohid Square, Dr. Sheikh Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
1358- 91735
Phone
+98 51 3726 9021
Email
azarfara@mums.ac.ir
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 data can be shared after patients are made unidentifiable.
When the data will become available and for how long
Data can be accessible 6 months after results are published.
To whom data/document is available
Data will be available for researchers in universities and other scientific institutes.
Under which criteria data/document could be used
Carrying out analysis on data is permitted.
From where data/document is obtainable
Data can be accessible through sending an email to the corresponding author.
What processes are involved for a request to access data/document
After sending a request email to the corresponding author, data will be sent in 1 month.