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Comparison of the efficacy and side effects of Desmopressin melting tablets and nasal spray in the treatment of primary enuresis in children aged 6 to 12 years

Protocol summary

Study aim
Determining the effectiveness and side effects of melt tablets compared to desmopressin spray in the treatment of primary enuresis in children aged 6 to 12 years.
Design
It is a randomized parallel study, without blinding, with a sample size of 110 people in the intervention group and 110 people in the control group. The intervention group uses sublingual tablets and the control group uses desmopressin spray. Blocked method is used for randomization
Settings and conduct
People aged 6 to 12 with primary enuresis who refer to Dr. Sheikh's Nephrology Clinic.
Participants/Inclusion and exclusion criteria
Participants: 6 to 12-year-olds with single-symptom nocturnal enuresis Exclusion from the study: having a history of organic urological disease, daily urinary incontinence, diabetes insipidus, persistent urinary tract infection, kidney, liver, digestive, pulmonary, cardiovascular, endocrine, or neurological diseases that are clinically important in the evaluation of disorders. and patients with lower urinary system symptoms who have bladder dysfunction.
Intervention groups
The group using sublingual tablets with a dose of 60 micrograms under 7 years and 120 micrograms over seven years.
Main outcome variables
Reducing the frequency of nocturnal urination

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230902059325N1
Registration date: 2024-03-07, 1402/12/17
Registration timing: prospective

Last update: 2024-03-07, 1402/12/17
Update count: 0
Registration date
2024-03-07, 1402/12/17
Registrant information
Name
Sara Ghasemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3661 9585
Email address
ghasemis4002@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-20, 1403/01/01
Expected recruitment end date
2025-05-22, 1404/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy and side effects of Desmopressin melting tablets and nasal spray in the treatment of primary enuresis in children aged 6 to 12 years
Public title
Comparison of the efficacy and side effects of Desmopressin melting tablets and nasal spray in the treatment of primary enuresis in children aged 6 to 12 years
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
6 to 12 years old Single-symptom nocturnal enuresis Able to use nasal spray or sublingual tablets Completion of the informed consent form by the guardian or legal guardian At least two weeks before the start of the study, he did not receive any medicine
Exclusion criteria:
Having a history of organic urological disease, daily urinary incontinence, diabetes insipidus, or persistent urinary tract infection Having clinically significant renal, hepatic, gastrointestinal, pulmonary, cardiovascular, endocrine, or neurological disease that interferes with evaluation Using antibiotics, diuretics or any medicine that affects the concentration of urine Failure to complete the informed consent form
Age
From 6 years old to 12 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 220
Randomization (investigator's opinion)
Randomized
Randomization description
In the present study, the randomization method will be used. These blocks include 6, 8, 10, and 14 blocks, which have an equal number of each group in each block. (For example, in a block of 6, 3 patients will be in the control group and three patients will be in the intervention group). This method creates a balance in the number of patients assigned to each of the intervention and control groups. Random sequence generation using the site www.sealedenvelop.com will be done
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 Mashhad University of Medical Sciences
Street address
Faculty of Medicine, Mashhad University of Medicine, Kalantari Highway
City
Mashhad
Province
Razavi Khorasan
Postal code
9189956458
Approval date
2023-04-18, 1402/01/29
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1402.077

Health conditions studied

1

Description of health condition studied
Enuresis
ICD-10 code
F98.0
ICD-10 code description
nonorganic enuresis

Primary outcomes

1

Description
Nocturia frequency
Timepoint
The period before the study, during one month after starting the drug and the follow-up period three months later
Method of measurement
Recording wet or dry nights in a notebook, by parents

Secondary outcomes

empty

Intervention groups

1

Description
Desmopressin Acetate tablets are used sublingually from FERRING Company under the brand name of MELT , for patients under 7 years of age, the dose is 60 micrograms, and for patients over 7 years old, 120 micrograms is used sublingually half an hour before going to sleep. Our study includes an examination before The study will be a two-week period without treatment, a basic assessment of patients in terms of nutritional status and response to alarm therapy, and then the start of drug treatment for one month and follow-up for the next three months. The effect of the drug will be checked one month after the start of the drug. Within one month after the start of the drug and the follow-up period of three months after that, they will be checked in terms of drug side effects and response to treatment.​
Category
Treatment - Drugs

2

Description
Control group: Desmopressin Acetate nasal spray under the brand name Desmex from Sinadaroo Company is used for children under seven years of age with a dose of 10 to 20 micrograms and for children over seven years of age with a dose of more than 20 micrograms at night half an hour before going to sleep. Our study includes a pre-study examination, a two-week period without treatment, a basic assessment of patients in terms of nutritional status and response to alarm therapy, and then the start of drug treatment for one month and follow-up in the next three months.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Dr Sheykh hospital
Full name of responsible person
Sara Saadat
Street address
Dr Sheikh Hospital. 3, Dr Sheykh Alley. 6, Gharani Ave. Gharani Blvd. Mashhad city
City
Mashhad
Province
Razavi Khorasan
Postal code
9139963185
Phone
+98 51 3724 9423
Email
saadats@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Mashhad Medical Science and Research Deputy, Qureishi Building, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9139963185
Phone
+98 51 3727 3943
Email
Ramresearch@mums.ac.ir
Web page address
https://www.mums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Sara Saadat
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Dr Sheikh Hospital. 3, Dr Sheykh Alley. 6, Gharani Ave. Gharani Blvd. Mashhad city
City
Mashhad
Province
Razavi Khorasan
Postal code
9139963185
Phone
+98 51 3724 9423
Email
Saadats@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Sara Saadat
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Dr Sheikh Hospital. 3, Dr Sheykh Alley. 6, Gharani Ave. Gharani Blvd. Mashhad city
City
Mashhad
Province
Razavi Khorasan
Postal code
9139963185
Phone
+98 51 3724 9423
Email
Saadats@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Sara Saadat
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Dr Sheikh Hospital. 3, Dr Sheykh Alley. 6, Gharani Ave. Gharani Blvd. Mashhad city
City
Mashhad
Province
Razavi Khorasan
Postal code
9139963185
Phone
+98 51 3724 9423
Email
saadats@mums.ac.ir

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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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