The objective of this prospective, randomized, clinical trial is to compare the efficacy of interferential currents (IFC) nasal spray of Desmopressin in the treatment of primary nocturnal enuresis of 5-15 years old children in Mofateh Clinic of Yasuj in Iran. Seventy five children with primary nocturnal enuresis were randomly assigned to receive Desmopressin (20 µg/day ) for 3 weeks and if was responsive, leave off gradually in six months or IFC therapy (5 times /week, 20 minutes / sessions, up to 15 sessions). Efficacy of treatment was evaluated after accomplishment of therapeutic sessions and recurrence rate was evaluated one month later.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138801161323N3
Registration date:2009-11-21, 1388/08/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2009-11-21, 1388/08/30
Registrant information
Name
Sadrollah Mehrabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3334 6070
Email address
dr.mehrabi@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research, Yasuj University of Medical Sciences
Expected recruitment start date
2007-04-21, 1386/02/01
Expected recruitment end date
2008-02-20, 1386/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Interferential currents and desmopressin in primary nocturnal enuresis of 5-15 years old children: A Randomized clinical trial
Public title
Interferential currents and desmopressin in primary nocturnal enuresis of 5-15 years old children: A Randomized clinical trial.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age 5-15 years, presence of primary nocturnal enuresis that at least had history of two times nocturnal bed wetting per week
Exclusion criteria: Any history of urinary tract infections, diurnal enuresis, organic disease and abnormality of urinary systems, resistance to other treatments modalities
Age
From 5 years old to 15 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Yasuj University of Medical Sciences
Street address
Yasuj University of Medical Sciences, Motahari St.
City
Yasuj
Postal code
7591741417
Approval date
2007-06-07, 1386/03/17
Ethics committee reference number
ب/23/2/1823
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
Complete improvment of enuresis
Timepoint
first month every two week then monthy for 6 months
Method of measurement
observation by parents
2
Description
Partial improvment of enuresis
Timepoint
First month every two weeks and then monthly for 6 months
Method of measurement
At least 50% decrease in bed wetting observed by parents
Secondary outcomes
1
Description
Recurrence of enuresis
Timepoint
one month after discontiuation of intervention
Method of measurement
observation by parents
2
Description
Adverse effects
Timepoint
First month every two weeks and then monthly for six months
Method of measurement
Report by patients or parents or observer
Intervention groups
1
Description
Nasal spray of Vasopressin, 10-20 microgram every night for three to four months and gradual tapering within 6 months
Category
Treatment - Drugs
2
Description
5 weeks treatment by IFC, three sessions per week for 20 minutes
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shaheed Mofateh clinic,Yasuj University of Medical Sciences
Full name of responsible person
Sadrollah Mehrabi
Street address
Shaheed Beheshti hospital, Montazeri street.
City
Yasuj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research management affairs, Yasuj University of Medical Sciences
Full name of responsible person
Mehdi Akbartabar
Street address
Emam Sajad Hospial, Yasuj university of medical science
City
Yasuj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research management affairs, Yasuj 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
Yasuj University of Medical Sciences, Yasuj, Iran
Full name of responsible person
Sadrollah Mehrabi
Position
Associate Professor, Fellowship of endourology
Other areas of specialty/work
Street address
Yasuj University of Medical Sciences, Motahari street.
City
Yasuj
Postal code
7591741417
Phone
+98 74 1333 7228
Fax
Email
mehrabi390@yahoo.com and dr mehrabiyums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Medical school, Yasuj University of Medical Sciences
Full name of responsible person
Sadrollah Mehrabi
Position
Associate professor, Fellowship of endourology, Urology department, Yasuj University of Medical Scie
Other areas of specialty/work
Street address
Yasuj University of Medical Sciences, Motahari street
City
Yasuj
Postal code
759741417
Phone
+98 74 1222 6517
Fax
Email
mehrabi390@yahoo.com and dr mehrabiyums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Urology Department, Yasuj University of Medical Sciences
Full name of responsible person
Sadrollah Mehrabi
Position
Associate Professor, Fellowship of endourology.
Other areas of specialty/work
Street address
Motahari street, Yasuj university of medical science Yasuj
City
Yasuj
Postal code
7591741417
Phone
+98 74 1333 7228
Fax
+98 74 1222 6517
Email
mehrabi390@yahoo.com and dr mehrabiyums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)