Recurrence of primary enuresis after treatment with desmopressin compare with combination therapy desmopressin and tolterodine in children aged 5-16 years
Determination of primary nocturnal enuresis recurrence in Desmopressin treatment compared to combination therapy of Desmopressin and Toltrudin in children 5-16 years old.
Design
A clinical trial with a control group, with parallel groups, double-blind, randomized, phase 2 on 124 patients. Patients will be randomly divided into two groups by random allocation with permuted blocks then order selected with random numbers generated by the computer. The therapist and the patient will be unaware of the treatment allocation.
Settings and conduct
Nephrology clinic of Qods hospital in Qazvin.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with primary monosymptomatic enuresis; No underlying disease or any anatomical abnormalities of the kidney on ultrasound; Age 5 to 16 years; Have informed consent to participate or withdraw from the study; nocturnal enuresis at least three nights a week.
Exclusion criteria: Patients with nocturnal enuresis with daily urinary disorder symptoms, such as emergency urinary incontinence, frequent urination or reduced frequency of urine per day, everyday urination holding maneuvers; Patients with urinary tract infection (positive urine culture), fasting blood sugar, kidney dysfunction (high creatinine), anatomical disorders of kidney in ultrasonography.
Intervention groups
The intervention group receives ِDesmopressin, and Toltrudin and the control group receives Desmopressin and placebo.
Main outcome variables
Early enuresis recurrence
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210714051893N1
Registration date:2021-08-22, 1400/05/31
Registration timing:prospective
Last update:2021-08-22, 1400/05/31
Update count:0
Registration date
2021-08-22, 1400/05/31
Registrant information
Name
Fereshteh Sobhani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8849 5179
Email address
fereshteh.sobhani23@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-23, 1400/07/01
Expected recruitment end date
2022-09-22, 1401/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Recurrence of primary enuresis after treatment with desmopressin compare with combination therapy desmopressin and tolterodine in children aged 5-16 years
Public title
"Combination therapy in recurrence of enuresis"
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients have monosymptomatic primary enuresis.
Patients without any anatomical disorder of kidney in sonography
Patients aged 5 -16 years
Knowledgeably compliance for entry or exit from research
Exclusion criteria:
Patients with enuresis with symptoms of daily urinary disorders, such as urgent urinary incontinence, frequent urination, or reduced urination frequency per day, urinary retention maneuvers during the day.
Patients with urinary tract infection (positive urine culture),
fasting blood sugar,
renal dysfunction (high creatinine),
Anatomical abnormalities of the kidney on ultrasound,
patients previously treated for enuresis
patients with incomplete information, and no referrals
if the child does not have enuresis (has gained control of urination) and later has enuresis
secondary enuresis
Age
From 5 years old to 16 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
124
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided into two groups. (By random allocation method with variable blocks that creates six different states (TCCT). TCTC TTCC. CTTC. CTCT. CCTT). Then the order will be selected by random numbers created by the computer). The therapist and the patient do not know about the group allocation. In addition, the Quickcals graphpad program is used for randomization.
Blinding (investigator's opinion)
Double blinded
Blinding description
Double-blind, Patients and the therapist are not aware of the type of allocation. For this purpose, the drugs are divided into packages containing codes 1 or 2. Only the principal investigator is aware of the type of intervention.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Qazvin University of Medical Sciences
Street address
Qods hospital,Qods square
City
Qazvin
Province
Qazvin
Postal code
3415914595
Approval date
2021-06-23, 1400/04/02
Ethics committee reference number
IR.QUMS.REC.1400.138
Health conditions studied
1
Description of health condition studied
Primary monocympetic nocturnal enuresis
ICD-10 code
N39.44
ICD-10 code description
Nacturnal enuresis
Primary outcomes
1
Description
Nocturnal enuresis
Timepoint
After starting treatment, patients will be visited monthly. If there is a partial or no response up to two weeks after treatment, possible factors of resistance to treatment such as constipation, bladder disorders or not taking the drug properly will be investigated. Failure to respond to treatment refers to one or more night wetting in two consecutive weeks during treatment and response to treatment is defined as dryness in two consecutive weeks.After three months of treatment, the drugs are discontinued overnight for one month. Re-visits are performed two weeks after treatment and recurrence of nocturnal enuresis (more than three nights wetting per week) will be checked.
Method of measurement
Response to treatment questionnaire.
Secondary outcomes
1
Description
Early enuresis recurrence
Timepoint
En After starting treatment, patients will be visited monthly. If there is a partial or no response up to two weeks after treatment, possible factors of resistance to treatment such as constipation, bladder disorders or not taking the drug properly will be investigated. Failure to respond to treatment refers to one or more night wetting in two consecutive weeks during treatment and response to treatment is defined as dryness in two consecutive weeks.After three months of treatment, the drugs are discontinued overnight for one month. Re-visits are performed two weeks after treatment and recurrence of nocturnal enuresis (more than three nights wetting per week) will be checked.
Method of measurement
En Response to treatment questionnaire.
Intervention groups
1
Description
Control group: Patients will be randomly divided into two groups: (CCTT) by random allocation with variable blocks that create six different states. CTCT. CTTC. TTCC TCTC. (TCCT) and then the blocks are selected with random numbers generated by the computer. The therapist and the patient are not aware of the therapeutic allocation. The first group is given 10 micrograms of Desmopressin nasal spray (one puff) one hour before bedtime and patients will be visited after the start of monthly treatment.If there is a partial or no response within two weeks of treatment, possible factors for resistance to treatment, such as constipation, bladder disorders, or improper medication, are evaluated. Failure to respond to treatment to one or more overnight wetting for two consecutive weeks during treatment and response to treatment refers to being dry for two consecutive weeks (provided the medication is used continuously). Night in between and then cut off.Re-visit two weeks after treatment and recurrence of enuresis (wetting more than three nights a week) will be checked. It is used as an active ingredient and each puff contains 10 micrograms of desmopressin acetate. The following recommendations will be made to patients in both groups.1. Adequate fluid intake during the day by limiting fluids to two hours before bedtime 2. Do not drink caffeinated beverages in the afternoon and evening 3. Empty the bladder before bedtime.
Category
Treatment - Drugs
2
Description
Intervention group: The second group given 10 microgram of Desmopressin nasal spray (one puff)with Tolterodine tablets (1/2 of tablet)(Sanamad Pharmaceutical Company) one hour before bedtime. will also be prescribed to the second group of patients.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Qods hospital
Full name of responsible person
Fereshteh Sobhani
Street address
Qods hospital,Qods square
City
Qazvin
Province
Qazvin
Postal code
3415914595
Phone
+98 28 3333 4807
Email
fereshteh.sobhani23@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Fereshteh Sobhani
Street address
Qods hospital,Qods square
City
Qazvin
Province
Qazvin
Postal code
3415914595
Phone
+98 28 3333 4807
Email
fereshteh.sobhani23@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Fereshteh Sobhani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Qods hospital,Qods square
City
Qazvin
Province
Qazvin
Postal code
3415914595
Phone
+98 28 3333 4807
Email
fereshteh.sobhani23@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Fereshteh Sobhani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Qodshospital,Qods square
City
Qazvin
Province
Qazvin
Postal code
3415914595
Phone
+98 28 3333 4807
Email
fereshteh.sobhani23@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Fershteh Sobhani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Qods hospital,Qods square
City
Qazvin
Province
Qazvin
Postal code
3415914595
Phone
+98 28 3333 4807
Email
fereshteh.sobhani23@gmaile.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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
The analysis result of all data can be detected and tracked.
When the data will become available and for how long
6 months after printing the results.
To whom data/document is available
All researchers.
Under which criteria data/document could be used
To conduct further research in the future.
From where data/document is obtainable
To Research Center of Qazvin University of Medical Sciences.
What processes are involved for a request to access data/document
Administrative and academic process according to university rules.