Determine and compare the effects of tolterodine treatment with oxybutynin in the treatment of enuretic children resistant to Desmopressin
Design
Triple blind randomized clinical trial without control group, community-based, with parallel groups, alternately randomization of the patients and a sample size of 61 ones.
Settings and conduct
Primary nocturnal enuresis patients who did not respond to desmopressin therapy and referred to the Booali hospital pediatric nephrology clinic are randomly divided into two groups of tolterodine + desmopressin or oxybutynin + desmopressin for three months. The patients' response to treatment will be checked 6 weeks after the start of treatment and at the end of the 12th week in the form of telephone follow-up or in-person interviews and complications of the drug will be recorded. The patient, investigator and the data analyser will not be aware of the drug.
Participants/Inclusion and exclusion criteria
Inclusion criteria: primary enuresis; no evidence of secondary enuresis in clinical examinations and urinalysis and sonography; no response to Nasal Desmopressin.
Exclusion criteria: secondary enuresis; underlying genitourinary system anomalies; interruption of follow up of the patient
Intervention groups
Group 1 children that will recieve Oxybutinin besides desmopressin and Group 2 children that will recieve tolterodin besides desmopressin.
Main outcome variables
The frequency of enuresis in night; frequency of enuresis in a week; response to treatment in a week; response to treatment in a night; drug side effect
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141224020419N3
Registration date:2019-07-02, 1398/04/11
Registration timing:registered_while_recruiting
Last update:2019-07-02, 1398/04/11
Update count:0
Registration date
2019-07-02, 1398/04/11
Registrant information
Name
Hamid Mohammadjafari
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3331 3866
Email address
hmjafari@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-22, 1397/09/01
Expected recruitment end date
2019-11-22, 1398/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of comparison of the efficacy of Tolterodine versus Oxybutynin in treatment of enuretic children resistant to Desmopressin
Public title
Efficacy of Tolterodine versus Oxybutynin in treatment of enuresis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Primary enuresis
No evidence of secondary enuresis in clinical examination, urine analysis and sonography
No response to nasal desmopressine
Exclusion criteria:
Secondary enuresis
Underlying genitourinary system anomalies
Interruption of follow up of the patient
Age
From 5 years old to 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
61
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be divided into two groups with statistical software receiving Tolterodine plus desmopressin or oxybutynin plus desmopressin for three months by simple randomization method
Blinding (investigator's opinion)
Triple blinded
Blinding description
The patient, investigator, and data analyzer will not be aware about the type of drug
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Māzandarān University of Medical Sciences
Street address
Moalem
City
Sari
Province
Mazandaran
Postal code
4818856361
Approval date
2019-05-18, 1398/02/28
Ethics committee reference number
IR.mazums.rec.1398.219
Health conditions studied
1
Description of health condition studied
Noctural enuresis
ICD-10 code
R32
ICD-10 code description
Unspecified urinary incontinence
Primary outcomes
1
Description
Noctural enuresis in night
Timepoint
Beginning of the study, 6 and 12 weeks after beginning of the study
Method of measurement
The frequency of wetting every night
2
Description
Noctural enuresis in week
Timepoint
Beginning of the study, 6 and 12 weeks after beginning of the study
Method of measurement
The frequency of wetting in week
Secondary outcomes
empty
Intervention groups
1
Description
Intervention first group: The group receiving tolterodine (Made by Iran Daroo Co, 05-4 mg every night) 0.5 mg every night after dinner than could be titrated to 4 mg + desmopressin (Made by Iran Daroo Co, with dose of one 10 microgram puff on one side of the nose every night before bed which increase to two puffs of 20 microgram on every nose based on clinical response) for 12 weeks
Category
Treatment - Drugs
2
Description
The second intervention group: The group receiving oxybutynin (Made by Iran Daroo Co, 0.2 mg/kg every night before bed)+ desmopressin (Made by Iran Daroo Co, with dose of one 10 microgram puff on one side of the nose every night before bed which increase to two puffs of 20 microgram on every nose based on clinical response) for 12 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Nephrology clinic of Bouali Hospital of Sari
Full name of responsible person
Hamid Mohammad Jaafari, MD
Street address
Booali hospital, Pasdaran boulevard, Sari, Iran
City
Sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 11 3334 2334
Fax
+98 11 3334 2334
Email
hamidmjaafari@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Majid Saeedi
Street address
Vice chancellor for research of Mazandaran university of medical sciences, Moalem square, Sari, Iran
City
Sari
Province
Mazandaran
Postal code
4818856361
Phone
+98 11 3334 2334
Fax
+98 11 3448 4800
Email
saeedi_m_2001@yahoo.com
Grant name
Majid Saeedi
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sari University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Hamid Mohammadjaafari
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Booali hospital, Pasdaran boulevard, Sari
City
Sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 11 3334 2334
Email
hamidmjaafari@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Neda Ezoddin
Position
Resident of Pediatrics
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Booali hospital, Sari, Iran
City
Sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 11 3334 2334
Email
nezoddin@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Neda Ezoddin
Position
Resident of Pediatrics
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Booali hospital, Pasdaran Boulevard, Sari
City
Sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 11 3334 2334
Email
nezoddin@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available