Clinical trial of Effects of using low-dosage Imipramine and Desmopressin with normal dosage on nocturnal enuresis in children with a resistance against Desmopressin
Study goal: Studying the treatment effects of Desmopressin and low-dosage Imipramine with Desmopressin in treatment of primary nocturnal enuresis in children.
Study population of 40 patients of Dr. Sheikh Hospital in Mashhad will randomly be divided into two groups (after getting their approvals). Inclusion criteria are primary nocturnal enuresis and being over 6 years old. In case of drug side effects and not completing the treatment period the patient will be excluded from the study. Patients who are not treated after one month from using Desmopressin will be included in the study. First group will be receiving a compound of Desmopressin and low-dosage Imipramine (5 mg), while the second group will be treated with Desmopressin only. In case no response is achieved after 3 weeks of receiving Desmopressin, the treatment shall be stopped. According to the guideline, the drug can be used up to 3 months. The main goal of present study is to study the effects of drugs on nocturnal enuresis in children.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016082129459N1
Registration date:2017-09-03, 1396/06/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-09-03, 1396/06/12
Registrant information
Name
Elham Zahabi
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3767 0507
Email address
zahabie891@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Vice-President of Mashhad Medical Sciences University
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2017-06-20, 1396/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of Effects of using low-dosage Imipramine and Desmopressin with normal dosage on nocturnal enuresis in children with a resistance against Desmopressin
Public title
Effects of using low-dosage Imipramine and normal-dosage Desmopressin on nocturnal enuresis in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: primary nocturnal enuresis with single symptom; being of above 6 age; not having a kidney disorder; not having neurogenic bladder dysfunction; not being treated after using Desmopressin for one month.
Exclusion criteria: drug side effects; not completing the treatment period; allergy to Imipramine; suffering from heart disorder; suffering from heart arrhythmia.
Age
From 6 years old to 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization Method: Random Number Table
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi),Daneshgah 16, Daneshgah Street
City
Mashhad
Postal code
Approval date
2016-01-16, 1394/10/26
Ethics committee reference number
IR.MUMS.fm.REC.1394.610
Health conditions studied
1
Description of health condition studied
enuresis
ICD-10 code
R32
ICD-10 code description
Unspecified urinary incontinence
Primary outcomes
1
Description
Bed wetting
Timepoint
Number of not bed wetting of the patient will be evaluated at baseline, 2 weeks later, 1 month later and then monthly until 6 months
Method of measurement
questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Prescribed Desmopressin and 5 mg of Imipramine
Category
Treatment - Drugs
2
Description
Control group: Prescribed Desmopressin
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mashhad Dr.Sheikh Hospital
Full name of responsible person
Anoosh Azarfar, Associated professor, Subspecialist in children's nephrology
Street address
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of 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
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Anoosh Azarfar
Position
Associated professor, subspecialist in children's nephrology
Other areas of specialty/work
Street address
Dr. Sheikh Hospital, Tohid Square, Motahari Avenue
City
Mashhad
Postal code
Phone
+98 51 3726 9021
Fax
Email
azarfara@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Anoosh Azarfar
Position
Subspecialist in children's nephrology
Other areas of specialty/work
Street address
Dr. Sheikh Hospital, Tohid Square, Motahari Avenue
City
Mashhad
Postal code
Phone
+98 51 3726 9021
Fax
Email
azarfara@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Elham Zahabi
Position
Medical student
Other areas of specialty/work
Street address
Dr. Sheikh Hospital, Tohid Square, Motahari Avenue
City
Mashhad
Postal code
Phone
Fax
Email
zahabie891@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)