effectiveness of medicinal and non-medicinal therapy on the control of primary nocturnal enuresis of children in nephrology clinic of Mashhad Dr.Sheikh Hospital
Design
A desmopressin spray dispensing group will use the desomex that made in iran, and the dosage will be used every night (one papaya per nose) and the second group will be treated with non-medicated alarms or night bells and treated for a period of The month will continue and the number of nights will be calculated within one month
Settings and conduct
enuresis is a type of incontinence in children that appears in the form of a little and sudden wetness and is determined by unintentional depletion of bladder 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 children with enuresis and 6 to 18 years old will be included in the study and children with neurologic urinary disorders, congenital anomalies and obstruction issues will be excluded
Intervention groups
A desmopressin spray will be used every night (one puff per nose) and the second group will be treated with non-medicated alarms or night bells
Main outcome variables
Rate of control and improvement of incontinence after use of alarm vs desmopressin
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180428039453N1
Registration date:2018-07-09, 1397/04/18
Registration timing:registered_while_recruiting
Last update:2018-07-09, 1397/04/18
Update count:0
Registration date
2018-07-09, 1397/04/18
Registrant information
Name
Oveis Iraninejad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3865 4416
Email address
iranio901@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2019-02-20, 1397/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of medicinal(desmopressin) and non-medicinal(alarm) therapy on the control of nocturnal enuresis of children
Public title
Comparison of the effectiveness of medicinal and non-medicinal therapy on the control of nocturnal enuresis of children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
children with primary enuresis with 6 to 18 years old
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 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
20
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
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
2017-03-10, 1395/12/20
Ethics committee reference number
IR.MUMS.fm.REC.1395.634
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 enuresis alarm vs desmopressin
Timepoint
A month after use of enuresis alarm
Method of measurement
The therapeutic response will be divided into three levels more effectively and without any difference and less effect
Secondary outcomes
empty
Intervention groups
1
Description
Control group: This group contain of 10 patients will use desmopressin spray with the traditional name of desmex that made in iran, and the dosage will be used every night (one puff per nose)for a month.
Category
Treatment - Drugs
2
Description
Intervention group:this group contain of 10 patients will be treated with non-medicated alarms or night bells and treated for a period of The month will continue and the number of nights will be calculated within one month
Category
Treatment - Devices
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