The aim of this study was to compare the therapeutic effects of Desmopresin, Oxybutinin, and Imipramin on primary nocturnal enuresis. In this randomized controlled trial, 150 children, aged 5-14 years, referred to pediatric clinic for nocturnal enuresis were assigned to receive Imipramin, Desmopressin, or Oxybutinin for 6 weeks. Response to the treatment (discontinuing enuresis) and side effects was assessed one, two, three, and four months after the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138807042503N1
Registration date:2010-05-30, 1389/03/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-05-30, 1389/03/09
Registrant information
Name
Maryam Seyfhashemi
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 1333 0108
Email address
m-seyf@sem-ums.ac.ir
Recruitment status
Recruitment complete
Funding source
Semnan University of Medical Sciences
Expected recruitment start date
2009-04-21, 1388/02/01
Expected recruitment end date
2010-04-20, 1389/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of the therapeutic effect of Desmopresin, Oxybutinin, and Imipramin in the treatment of nocturnal enuresis in children
Public title
The comparison of the therapeutic effect of Desmopresin, Oxybutinin, and Imipramin in the treatment of nocturnal enuresis in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age 5-14, presence of nocturnal enuresis, patient's and parents consent for treatment and follow up, no underlying diseases, not receiving any medicine for enuresis during 6 months prior to the study, failure to response to the other non pharmacological therapies
Exclusion criteria: disagreement of parents or patients for treatment, developing any drugs side effects
Age
From 5 years old to 14 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
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
Ethic committee of Semnan University of Medical Sciences
Street address
Basij Blv,
City
Semnan
Postal code
Approval date
empty
Ethics committee reference number
A-2391
Health conditions studied
1
Description of health condition studied
Nucturia
ICD-10 code
F98.0
ICD-10 code description
Nonorganic enuresis
Primary outcomes
1
Description
Response rate (discontinuing enuresis)
Timepoint
1, 2, 3, and 4 months after intervention
Method of measurement
observation and interview and collecting data from questionnaires
Secondary outcomes
empty
Intervention groups
1
Description
Desmopressin, nasal spray, 1-2 puff every night for 6 weeks
Category
Treatment - Drugs
2
Description
Oxybutinin 5mg, po, at bedtime every night for 6 weeks
Category
Treatment - Drugs
3
Description
Imipramin, 10-20 mg, po, at bedtime every night for 6 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Semnan University of Medical Sciences, Amir al Momenin Hospital
Full name of responsible person
Street address
City
Semnan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr Raheb Ghorbani
Street address
Basij Blv.
City
Semnan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan University of Medical Sciences
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
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Maryam Seyfhashemi
Position
Assistant Professor of Pediatrics
Other areas of specialty/work
Street address
Amir al Momenin Hospital, Madar Squ.
City
Semnan
Postal code
Phone
+98 23 1444 6309
Fax
Email
m-Seyf@sem-ums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Maryam Seyfhashemi
Position
Assistant Professor of Pediatrics
Other areas of specialty/work
Street address
Amir al Momenin Hospital, Madar Squ.
City
Semnan
Postal code
Phone
+98 23 1444 6309
Fax
Email
m-seyf@sem-ums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Maryam Seyfhashemi
Position
Assistant Professor of Pediatrics
Other areas of specialty/work
Street address
Amir al Momenin Hospital, Madar Squ.
City
Semnan
Postal code
Phone
+98 23 1444 6309
Fax
Email
m-seyf@sem-ums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)