Comparison of the Effectiveness of Desmopressin-Oxybutynin with Fluvoxamine in Treatment of Nocturnal Enuresis in Children referring to Nephrology Clinic
Comparison of the Effectiveness of Desmopressin-Oxybutynin with Fluvoxamine in Treatment of Nocturnal Enuresis in Children referring to Nephrology Clinic
Design
In this study, all patients Older than eight years old with Nocturnal Enuresis resistant to behavioral therapy & first-line medication therapy who refer to Nephrology Clinic, after being informed and acquisition of consent, will be included in the study.
Settings and conduct
Primary Nocturnal Enuresis is the involuntary discharge of urine at night by children old enough to be expected to have bladder control and bladder control has never been attained. 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 divided to 3 levels as following: 1-no response 2- relative response as reduction of nocturnal enuresis to less than 2 times in a month and 3- complete improvement
Participants/Inclusion and exclusion criteria
All patients Older than eight years old with Nocturnal Enuresis resistant to behavioral therapy & first-line medication therapy will be included in the study and children with Major Depression Disorder,Anxiety,etc will be excluded.
Intervention groups
Intervention group:
En Intervention group: Patients are prescribed 25 milligram of Fluvoxamine nightly for one month.
Control group: Patients will be given Oxybutynin drug with dose of 0.1 milligram per kilogram and Desmopressin 10 to 20 microgram intranasal for one month
Main outcome variables
Rate of control and improvement of nocturnal enuresis after use of Fluvoxamine
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171112037417N1
Registration date:2018-05-20, 1397/02/30
Registration timing:registered_while_recruiting
Last update:2018-05-20, 1397/02/30
Update count:0
Registration date
2018-05-20, 1397/02/30
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 517602947
Email address
alizadeha901@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-25, 1397/02/05
Expected recruitment end date
2018-06-26, 1397/04/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of Desmopressin-Oxybutynin with Fluvoxamine in Treatment of Nocturnal Enuresis in Children referring to Nephrology Clinic
Public title
Comparison of the Effectiveness of Desmopressin-Oxybutynin with Fluvoxamine in Treatment of Nocturnal Enuresis in Children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Older than eight years old patients with Nocturnal Enuresis resistant to behavioral therapy & first-line medication therapy
Exclusion criteria:
Patients with Major Depression Disorder,Anxiety,etc
Age
From 8 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
30
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
2017-10-11, 1396/07/19
Ethics committee reference number
IR.MUMS.sm.REC.1396412
Health conditions studied
1
Description of health condition studied
Nocturnal Enuresis
ICD-10 code
F98.0
ICD-10 code description
Enuresis not due to a substance or known physiological condition
Primary outcomes
1
Description
Rate of control and improvement of nocturnal enuresis after use of Fluvoxamine
Timepoint
A month after use of Fluvoxamine
Method of measurement
Medical response is divided to 3 levels as following: 1-no response 2- relative response as reduction of nocturnal enuresis to less than 2 times in a month and 3- complete improvement
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients are prescribed 25 milligram of Fluvoxamine nightly for one month
Category
Treatment - Drugs
2
Description
Control group: Patients will be given Oxybutynin drug with dose of 0.1 milligram per kilogram and Desmopressin 10 to 20 microgram intranasal 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.