The aim of this study is to compare treatment of monosymptomatic nocturnal enuresis with combination of Desmopressin and Tolterodin versus Desmopressin alone. The key inclusion criteria is be to have primary nocturnal enuresis and the key exclusion criteria are occurrence of side effects or missing the intake of more than two doses of the prescribed medication. One hundred patients with primary nocturnal enuresis from both genders aged between 5 to 16 referring to the urology clinic of Emam Reza hospital, Tabriz, Iran in a randomized unicentral double blinded clinical trial are assigned to receive Tolterodin 2 mg/day orally plus nasal Desmopressin 1 puff/night (two-drug regimen group) for 4 weeks or to receive nasal Desmopressin 1 puff/night and placebo (one-drug regimen group) with the same shape, size and color of the Tolterodin in a similar dose and duration. Individuals would be visited for occurrence of probable side effects and regularity of drug intake at the end of each week and number of nocturnal urination would be recorded to make comparison between the groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012090610758N1
Registration date:2012-09-24, 1391/07/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-09-24, 1391/07/03
Registrant information
Name
Fahimeh Kazemi Rashed
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1658 4153
Email address
kazemirashedf@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2012-04-04, 1391/01/16
Expected recruitment end date
2012-10-06, 1391/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of treatment of monosymptomatic nocturnal enuresis with combination of Desmopressin and Tolterodin versus Desmopressin alone
Public title
Comparison of two regimens in the treatment of nocturnal enuresis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: (having primary nocturnal enuresis; not having secondary nocturnal risk factors such as urinary tract infection, constipation, Diabetes Mellitus, Diabetes Insipidus, obstruction of the urinary tract, neurogenic bladder and positive history of seizure; to be between 5 to 16 years old)
Exclusion criteria: (having abnormal sonographic or urine analysis results; occurrence of side effects or missing the intake of more than two doses of the prescribed drugs)
Age
From 5 years old to 16 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
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
2011-10-05, 1390/07/13
Ethics committee reference number
9183
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 four weeks
Method of measurement
Using a questionnaire
Secondary outcomes
1
Description
Occurrence of side effects
Timepoint
Weekly for four weeks
Method of measurement
Physical examination by a specialist
Intervention groups
1
Description
In two-drug regimen group: Tolterodin 2 mg/day orally plus nasal Desmopressin 1 puff/night for 4 weeks
Category
Treatment - Drugs
2
Description
In one-drug regimen group: nasal Desmopressin 1 puff/night and placebo with the same shape, size and color of the Tolterodin once per night orally for 4 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza hospital
Full name of responsible person
Fahimeh Kazemi Rashed
Street address
Emam Reza hospital, Golgasht ave.
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
Adorreza Otofat
Position
Residet of urology
Other areas of specialty/work
Street address
Urology ward, Emam Reza hospital, Golgasht ave.
City
Tabriz
Postal code
Phone
+98 41 1658 4305
Fax
Email
dr.otofat@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
Fahimeh Kazemi Rashed
Position
Associate professor of urology
Other areas of specialty/work
Street address
Urology ward, Emam Reza hospital, Golgasht ave.
City
Tabriz
Postal code
Phone
+98 41 1658 4305
Fax
Email
kazemirashedf@tbzmed.ac.ir
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
City
Tabriz
Postal code
Phone
+98 41 1658 4305
Fax
Email
mehdi.hemmati@rocketmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)