Comparison of the Effectiveness of Hydrochlorothiazide with Nasal Spray of Desmopressin in Treatment of Nocturia in Children Referring to Pediatric Nephrology Clinic in hamadan in first 6 month of 2019
Determining the efficacy of hydrochlorothiazide in the treatment of nocturnal enuresis children in Hamadan province
Design
All patients with a diagnosis of primary nocturnal enuresis
according to the age and sex enrolled to study Based on the inclusion criteria for entry and absence of exclusion criteria, and after obtaining informed consent, they are included in the study and according to the protocol on treatment of nocturnal enuresis in two groups, the control group and the case group are based on gradual and sequential outcome by simple randomization and double blind The control group is based on the current protocol of nasal spray desmopressin 10-20 micrograms athe bed time .In the case group patients undergoing thiazide diuretics hydrochlorothiazide 1mg/kg at the morning in single dose placed.
Settings and conduct
A clinical trial study performed in Hamedan in girls over 5 years of age and boys over 6 years of age with primary nocturnal enuresis
Participants/Inclusion and exclusion criteria
Having inclusioncriteria and no exclusion hcriteria
Intervention groups
Use of hydrochlorothiazide in the case group for the treatment of enuresis in children
The control group is based on the current protocol of nasal spray desmopressin 10-20 micrograms athe bed time .In the case group patients undergoing thiazide diuretics hydrochlorothiazide 1mg/kg at the morning in single dose placed.
Main outcome variables
Resolved of Enoresis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181212041936N1
Registration date:2019-01-23, 1397/11/03
Registration timing:registered_while_recruiting
Last update:2019-01-23, 1397/11/03
Update count:0
Registration date
2019-01-23, 1397/11/03
Registrant information
Name
rahimpour amiri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3264 0042
Email address
r.amiri@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-22, 1397/06/31
Expected recruitment end date
2019-03-19, 1397/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of Hydrochlorothiazide with Nasal Spray of Desmopressin in Treatment of Nocturia in Children Referring to Pediatric Nephrology Clinic in hamadan in first 6 month of 2019
Public title
Comparison of the Effectiveness of Hydrochlorothiazide with Nasal Spray of Desmopressin in Treatment of Nocturia in Children Referring to Pediatric Nephrology Clinic in hamadan in first 6 month of 2019
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All girls aged more than 5 years old and all boys over 6 years of age with diagnosis of primary monosymptomatic nocturnal enuresis referred to the nephrology clinic of children
Exclusion criteria:
Anatomical disorders lead to urinary incontinence such as neurogenic bladder, posterior ureteral valve and anatomical disorders of the ureter
Metabolic disorders leading to polyuria such as diabetes mellitus and diabetes insipid
secondary nocturnal enuresis
polysymptomatic nocturnal enuresis
Parental dissatisfaction
adverse effects of drugs
Age
From 5 years old to 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
208
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization, block
Blinding (investigator's opinion)
Double blinded
Blinding description
The two groups of the control group and the case group are included in the study according to the simple sequential randomization method. The investigator and the patients do not know how to enter the groups, and the individuals enter the group with the code. The control and case groups are also coded and only Analysts are aware
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamadan University of Medical Sciences
Street address
Hamedan university of medical sciences., No. 65178, Shahid fahmide Ave., Hamadan Province., Hamedan Town, Iran
City
Hamadan
Province
Hamadan
Postal code
6514845471
Approval date
2018-11-30, 1397/09/09
Ethics committee reference number
IR.UMSHA.REC.1397.627
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
Resolved of Enuresis
Timepoint
Patients are followed up for a period of 6 months, and the outcome of the disease is the drying up of the child during sleep during medication three months and within three months after it, after discontinuation of drugs, in addition to monthly monitoring during the monthly visits to the families It will be explained if the child reports wetting the next day and if the child remains dry. Meanwhile, after the discontinuation of the medications within the next three months, follow-up and drying or returning of the enuresis will be considered.