Comparison of additive effect of solifenacin or tolterodine to desmopressin in treatment of children with primary nocturnal enuresis
Design
40 patients with primary nocturnal enuresis who has the inclusion criteria will be included. Patients will be randomly assigned to one of the two different therapeutic protocols and any participants will be given a specific code.
Settings and conduct
The study will be conducted in Urology clinic of Imam Khomeini hospital, Ahvaz, Iran. Patients were Randomly Selected. All participants will be evaluated monthly regarding treatment response and drug side effects for 6 months , after which the outcomes will be compared in both groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 5-15 years old children with primary nocturnal enuresis
Exclusion criteria: Neurogenic bladder, CNS disorders and/or urine-concentrating defects
Intervention groups
Group A: Will take Intranasal Desmopressin spray 1 puff/night plus Tolterodine 1 mg tablet/oral/night
Group B: Will take Intranasal Desmopressin spray 1 puff/night plus solifenacin 5 mg tablet/oral/night.
Main outcome variables
The main outcomes will be treatment response.
Treatment response will be regarded as full response (complete dry), good response (90- 99% reduction in wet nights), or partial response (50- 90% reduction).
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170509033894N3
Registration date:2018-01-31, 1396/11/11
Registration timing:retrospective
Last update:2018-01-31, 1396/11/11
Update count:0
Registration date
2018-01-31, 1396/11/11
Registrant information
Name
Seyedeh parvin Mosavi ghanavati
Name of organization / entity
univercity
Country
Iran (Islamic Republic of)
Phone
+98 61 3445 2149
Email address
ghanavati.p@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research deputy, Ahvaz Jundishapur Univercity of Medical Sciences
Expected recruitment start date
2017-05-22, 1396/03/01
Expected recruitment end date
2017-12-22, 1396/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comprasion of additive effect of solifenacin with tolterodine to desmopressin in treatment of children with primary nocturnal enuresis
Public title
Comparison of two treatment method in children with primary nocturnal enuresis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
children with primary nucturnal enurises
Exclusion criteria:
patients with neurogenic bladder
CNS disorders
urine-concentrating defects
Age
From 5 years old to 15 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly (blocking method) divided intwo groups
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 Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz, Golestan, Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Approval date
2017-05-11, 1396/02/21
Ethics committee reference number
IR.AJUMS.REC.1396.72
Health conditions studied
1
Description of health condition studied
nocturnal enuresis
ICD-10 code
F98.0
ICD-10 code description
Nonorganic enuresis
Primary outcomes
1
Description
Response to treatment
Timepoint
Monthly regarding during 6 months
Method of measurement
According things that their parents and children say, patients will be classified to full response (complete dry), good response (90 to 99% reduction in wet nights), and partial response (50 to 90% reduction).
Secondary outcomes
1
Description
Abdominal pain
Timepoint
Monthly during 6 months
Method of measurement
Clinical symptoms
2
Description
Vomiting
Timepoint
Monthly during 6 months
Method of measurement
Clinical symptoms
Intervention groups
1
Description
Intra nasal Desmopressin 1 puff/Qhs plus Tolterodine 1mg daily during 6 month
Category
Treatment - Drugs
2
Description
Intra nasal Desmopressin 1 puff/Qhs plus solifenacin 5 mg daily during 6 month
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahwaz Imam Khomeini hospital
Full name of responsible person
Seyedea parvin mosavi ghanavati
Street address
Sharifezadeh ave.,24metry
City
Ahwaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3445 2149
Email
sp.mg90@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology of Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Mohammad Badavi
Street address
Ahvaz, Golestan, Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3373 8594
Email
info@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research and Technology of Ahvaz Jundishapur University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
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
Ahvaz University of Medical Sciences
Full name of responsible person
Seyedeh Parvin Mosavi Ghanavati
Position
Medical student
Latest degree
Bachelor
Other areas of specialty/work
General Practitioner
Street address
Azadegan blv, Imam khomeni hospital
City
Ahvaz
Province
Khouzestan
Postal code
6785498765
Phone
+98 61 3221 6104
Fax
Email
sp.mg90@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dinyar Khazaeli
Position
Urologist
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Azadegan blv, Imam khomeni hospital
City
Ahvaz
Province
Khouzestan
Postal code
1234587659
Phone
+98 61 3221 6104
Fax
Email
drdyniar@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Seyyedeh Parvin Mousavi Ghanavati
Position
Medical Student
Latest degree
Bachelor
Other areas of specialty/work
General Practitioner
Street address
No.16,2th Ave.,saheli Blvd.,kinpars Town
City
Ahvaz
Province
Khouzestan
Postal code
6723456890
Phone
+98 61 3221 6104
Fax
Email
sp.mg90@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available