Comparison of desmopressin plus tolterodine with desmopressin plus indomethacin for the treatment of pediatric enuresis
Design
Two arm phase 2 parallel group randomized open-label trial of 40 patients, with randomization done using the Random Allocation software.
Settings and conduct
This open-label randomized clinical trial included children aged >5 and <18 years with mono- or disymptomatic enuresis referred to the Nephrology Clinic of Bandar Abbas Children's Hospital. Children in the desmopressin plus tolterodine group received 60 mcg desmopressin plus 2 mg tolterodine every night before bedtime and children in the desmopressin plus indomethacin group received 60 mcg desmopressin plus 50 mg indomethacin every night before bedtime. Response to treatment was compared between groups 1, 3, and 5 months after the initiation of treatment.
Participants/Inclusion and exclusion criteria
Inclusion: Age >5 and <18 years, diagnosis of mono- (nocturnal) or disymptomatic (nocturnal and diurnal) enuresis
Exclusion: Having previously received any treatment for enuresis, secondary causes of enuresis
Intervention groups
Desmopressin plus tolterodine group: 60 mcg desmopressin and 2 mg tolterodine every night before bedtime
Desmopressin plus indomethacin group: 60 mcg desmopressin and 50 mg indomethacin every night before bedtime
Main outcome variables
Response to treatment in the form of the number of dry nights per month
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210613051564N1
Registration date:2021-07-19, 1400/04/28
Registration timing:retrospective
Last update:2021-07-19, 1400/04/28
Update count:0
Registration date
2021-07-19, 1400/04/28
Registrant information
Name
Maryam Esteghamati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 7690
Email address
maryamesteghamati@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-21, 1397/01/01
Expected recruitment end date
2019-03-21, 1398/01/01
Actual recruitment start date
2018-03-21, 1397/01/01
Actual recruitment end date
2019-03-21, 1398/01/01
Trial completion date
2019-03-21, 1398/01/01
Scientific title
Comparison of combination therapy with desmopressin plus tolterodine and desmopressin plus indomethacin for the treatment of pediatric enuresis
Public title
Desmopressin plus tolterodine versus desmopressin plus indomethacin for pediatric enuresis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age >5 years and <18 years
Diagnosis of mono- or disymptomatic enuresis
Exclusion criteria:
Having previously received any treatment for enuresis
Secondary causes of enuresis, including anatomic disorders of the urinary system, trauma, constipation, diabetes mellitus, diabetes insipidus, urinary tract infection, and the like.
Age
From 6 years old to 17 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
40
Actual sample size reached:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was done by simple randomization using the randomization table generated by the Random Allocation software with individuals as the unit of randomization. This table contained numbers from 1 to 40 and in front of each number the name of either of the groups were randomly mentioned. Based on this table, the study groups were written in sealed envelopes numbered from 1 to 40 and each envelope was allocated to a single patient in order of their entrance to the study.
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 Hormozgan University of Medical Sciences
Street address
Technology and Research Vice-chancellery, East side of Payambar Azam Hospital, Bandar Abbas
City
Bandar Abbas
Province
Hormozgan
Postal code
7919915519
Approval date
2018-05-13, 1397/02/23
Ethics committee reference number
IR.HUMS.REC.1397.070
Health conditions studied
1
Description of health condition studied
Pediatric enuresis
ICD-10 code
N39.44
ICD-10 code description
Nocturnal enuresis
Primary outcomes
1
Description
Response to treatment in the form of the number of dry nights per month
Timepoint
1, 3, and 5 months after the initiation of treatment
Method of measurement
By asking the children's parents
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Desmopressin plus tolterodine: A 60 mcg desmopressin tablet from Ferring Pharmaceuticals Ltd., United Kindgdom, and a 2 mg tolterodine tablet from Alhavi Pharmaceutical Co., Iran, every night before bedtime
Category
Treatment - Drugs
2
Description
Intervention group: Desmopressin plus indomethacin: A 60 mcg desmopressin tablet from Ferring Pharmaceuticals Ltd., United Kindgdom, and two 25 mg indomethacin capsules from Loghamn Pharmaceutical & Hygienic Co., Iran, every night before bedtime
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Bandar Abbas Children's Hospital
Full name of responsible person
Maryam Esteghamati
Street address
Bandar Abbas Children's Hospital, Imam Khomeini Blvd., Bandar Abbas
City
Bandar Abbas
Province
Hormozgan
Postal code
7366579158
Phone
+98 76 3366 6242
Email
maryamesteghamati@gmail.com
Sponsors / Funding sources
1
Sponsor
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
empty
Title of funding source
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Technology and Research Vice-chancellery, Hormozgan University of Medical Sciences
Full name of responsible person
Nasrin Davari Dolatabadi
Street address
Technology and Research Vice-chancellery, East side of Payambar Azam Hospital, Bandar Abbas
City
Bandar Abbas
Province
Hormozgan
Postal code
7919915519
Phone
+98 76 3333 7379
Email
n.davari@hums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Technology and Research Vice-chancellery, Hormozgan 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
Bandar Abbas Children's Hospital
Full name of responsible person
Seyedeh Elaheh Mousavipour
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Bandar Abbas Children's Hospital, Imam Khomeini Blvd., Bandar Abbas
City
Bandar Abbas
Province
Hormozgan
Postal code
7366579158
Phone
+98 76 3366 6242
Email
mansor110110@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bandar Abbas Children's Hospital
Full name of responsible person
Seyedeh Elaheh Mousavipour
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Bandar Abbas Children's Hospital, Imam Khomeini Blvd., Bandar Abbas
City
Bandar Abbas
Province
Hormozgan
Postal code
7366579158
Phone
0098763366242
Email
masor110110@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Bandar Abbas Children's Hospital
Full name of responsible person
Seyedeh Elaheh Mousavipour
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Bandar Abbas Children's Hospital, Imam Khomeini Blvd., Bandar Abbas
City
Bandar Abbas
Province
Hormozgan
Postal code
7366579158
Phone
00987366579158
Email
mansor110110@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All collected data will be available after deidentification.
When the data will become available and for how long
Data will be available in 2022.
To whom data/document is available
People working in academic institutions
Under which criteria data/document could be used
Eligible individuals will be able to use the data for pooled analysis
From where data/document is obtainable
Via an email address: maryamesteghamati@gmail.com to Dr. Maryam Esteghamati
What processes are involved for a request to access data/document
Within a month of presenting a valid identification card