Compare of drug therapy (with oxibutinin, imipramine and desmopressin)with cognitive behavioral therapy to improve the rate of primary nocturnal enuresis in new school -aged children of education and training organization, referred to specialized clinics in 2014-2015
The aim of this is to compare drug therapy (with oxibutinin, imipramine and desmopressin) with cognitive behavioral therapy to improve the rate of primary nocturnal enuresis. In this randomized double blind controlled clinical trial 45 children aged 7 to 12 years referred to doctor Hamid Ostadebrahimi's pediatric office for nocturnal enuresis will be assigned to receive oxibutinin, imipramine, desmopressin and behavioral therapy. Response to treatment will be assessed one, two, three and four months after the treatment.Inclusion criteria are to have primary nocturnal enuresis and being 7 to 12years old. Exclusion criteria are to have neurogenic bladder, central nervous system disorders and secondary nocturnal enuresis.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201502091061N22
Registration date:2015-04-20, 1394/01/31
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-04-20, 1394/01/31
Registrant information
Name
Reza Vazirinejad
Name of organization / entity
Rafsanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 39 1822 0097
Email address
pejoheshi@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Rafsanjan University of Medical Sciences
Expected recruitment start date
2015-04-21, 1394/02/01
Expected recruitment end date
2015-12-22, 1394/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compare of drug therapy (with oxibutinin, imipramine and desmopressin)with cognitive behavioral therapy to improve the rate of primary nocturnal enuresis in new school -aged children of education and training organization, referred to specialized clinics in 2014-2015
Public title
Compare of drug therapy with cognitive behavioral therapy in improvement of enuresis in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion :to have primary nocturnal enuresis and being 7to 12 years old , exclusion :to have neurogenic bladder, central nervous system disorders and secondary nocturnal enuresis
Age
From 7 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
-
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Central Organization of Rafsanjan University of Medical Siences
Street address
Central Organization of Rafsanjan University of Medical Siences, Imam Ali Blvd, Rafsanjan
City
Rafsanjan
Postal code
7717933777
Approval date
2014-10-18, 1393/07/26
Ethics committee reference number
2017
Health conditions studied
1
Description of health condition studied
Primary enuresis
ICD-10 code
F98.0
ICD-10 code description
Nonorganic enuresis
Primary outcomes
1
Description
number of nocturnal enuresis
Timepoint
before the intervention
Method of measurement
olness questionnaire of nocturnal enuresis
Secondary outcomes
1
Description
response to drug therapy (oxibutinin, imipramine and desmopressin)
Timepoint
one, two, three and four months after the start of study
Method of measurement
olness questionnaire of nocturnal enuresis
2
Description
response to cognitive behavioral therapy
Timepoint
one, two, three and four months after the start of intervention
Method of measurement
olness questionnaire of nocturnal enuresis
Intervention groups
1
Description
imipramine tablet (50mg)before sleep for one month, oxibutinin tablet (5mg)two times a day for one month, desmopressin spray (20micro g)intra nasal before sleep for one month
Category
Treatment - Drugs
2
Description
cognitive behavioral therapy by using of less drinking before sleep, alarm clock wakes at night, enuresis alarm, hypnosis, trying to remember to keep dry, parents wakes at night, punishment for wet nights, rewards for dry nights
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
pediatric office
Full name of responsible person
Drive,Hamid Ostadebrahimi
Street address
Rafsanjan after shohada junction, hakim clinic
City
Rafsanjan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Siences
Full name of responsible person
Ali Esmaili Nadimi
Street address
Rafsanjan University of Medical Siences, Rafsanjan
City
Rafsanjan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan University of Medical Siences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Person responsible for scientific inquiries
Contact
Name of organization / entity
*
Full name of responsible person
Hamid Ostadebrahimi
Position
Pediatrician /Assistant Professor
Other areas of specialty/work
Street address
Central Organization of Rafsanjan University of Medical Siences, Imam Ali Blvd, Rafsanjan
City
Rafsanjan
Postal code
7717933777
Phone
+98 34 3428 0090
Fax
+98 34280071
Email
pazhoohesh.council@gmail. com
Web page address
www. rums. ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Central Organization of Rafsanjan University of Medical Siences, Imam Ali Blvd, Rafsanjan
Full name of responsible person
Hamid Ostadebrahimi
Position
Pediatrician
Other areas of specialty/work
Street address
Rafsanjan, imam Ali Blvd, central organization of medical sience university of Rafsanjan
City
Rafsanjan
Postal code
7717933777
Phone
+98 34 3428 0090
Fax
+98 34280071
Email
pazhoohesh.council@gmail
Web page address
www. rums. ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)