Comparison of the efficacy of two therapeutic regimens for primary nocturnal enuresis; oxybutnin plus desmopressin versus desmopressin in pediatric patients
Our aim in this study is to compare the efficacy of two therapeutic regimens for primary nocturnal enuresis; oxybutnin plus desmopressin versus desmopressin in pediatric patients. In a unicentral randomized trial 60 patients with age of 5 to 18 years from both genders with primary nocturnal enuresis referring to the nephrology clinic of Tabriz Children's hospital will be assigned in two equal-sized groups to receive combination of nasal desmopressin and oxybutinin or nasal desmopressin alone. Desmopressin spray will be administered 1 puff/night for all the patients and oxybutinin 0.5 to 1 tablet 3 times a day as needed. Inclusion criteria are to have primary nocturnal enuresis and being 5 to 18 years old. Exclusion criteria are to have neurogenic bladder; CNS disorders; secondary nocturnal enuresis. Three months after drug consumption patients in the groups would be evaluated in terms of presence of nocturnal enuresis.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201301117892N4
Registration date:2013-01-28, 1391/11/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-01-28, 1391/11/09
Registrant information
Name
Anoosh Azarfar
Name of organization / entity
Mashhad University of Medical Sciences, Faculty of Nursing and Midwifery
Country
Iran (Islamic Republic of)
Phone
+98 51 1606 1227
Email address
azarfara@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2012-08-31, 1391/06/10
Expected recruitment end date
2013-02-19, 1391/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of two therapeutic regimens for primary nocturnal enuresis; oxybutnin plus desmopressin versus desmopressin in pediatric patients
Public title
Comparison of the efficacy of two therapeutic regimens for primary nocturnal enuresis; oxybutnin plus desmopressin versus desmopressin in pediatric patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: (5 to 18 year-old patients with primary nocturnal enuresis)
Exclusion criteria: (to have neurogenic bladder; CNS disorders; secondary nocturnal enuresis; occurrence of drug side effects)
Age
From 5 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Ethics committee of Tabriz University of Medical Sciences
Street address
Vice chancellor for research, Tabriz University of Medical Sciences, Daneshgah square
City
Tabriz
Postal code
Approval date
2012-08-29, 1391/06/08
Ethics committee reference number
9158
Health conditions studied
1
Description of health condition studied
Primary nocturnal enuresis
ICD-10 code
F98.0
ICD-10 code description
Nonorganic enuresis
Primary outcomes
1
Description
Frequency of nocturnal urination in a week
Timepoint
weekly for 12 weeks
Method of measurement
Using a questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
In combination therapy group: Desmopressin nasal spray will be administered 1 puff/night and oxybutinin 0.5 to 1 tablet 3 times a day as needed for three months.
Category
Treatment - Drugs
2
Description
In one-drug group: Desmopressin nasal spray will be administered 1puff/night for 3 months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Children's Hospital
Full name of responsible person
Anoosh Azarfar, Assistant professor, Subspecialist in children's nephrology
Street address
Children's Hospital, Sheshgelan st.
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Alireza Ostad Rahimi
Street address
Vice chancellor for research, Tabriz University of Medical Sciences, Daneshgah square
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Anoosh Azarfar
Position
Assistant professor, subspecialist in children's nephrology
Other areas of specialty/work
Street address
Children's Hospital, Sheshgelan st.
City
Tabriz
Postal code
Phone
+98 41 1658 4153
Fax
Email
azarfar132@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Anoosh Azarfar
Position
Assistant professor, subspecialist in children's nephrology
Other areas of specialty/work
Street address
Children's Hospital, Sheshgelan st.
City
Tabriz
Postal code
Phone
+98 41 1658 4153
Fax
Email
azarfar132@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Scinces
Full name of responsible person
Mehdi Hemmati
Position
General physician
Other areas of specialty/work
Street address
Children's Hospital, Sheshgelan st.
City
Tabriz
Postal code
Phone
Fax
Email
mehdi.hemmati@rocketmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)