Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000156785
Ethics application status
Approved
Date submitted
4/02/2013
Date registered
8/02/2013
Date last updated
8/02/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
A questionnaire - based study assessing if urinary control during childhood associated with voiding habits in adult life?
Scientific title
Does maturation of sphincter control in childhood affect voiding habits in adult life? A questionnaire - based study.
Secondary ID [1] 281887 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Childhood urinary control 288287 0
Condition category
Condition code
Renal and Urogenital 288630 288630 0 0
Normal development and function of male and female renal and urogenital system

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Completion of a questionnare (The questionnare is going to be completed by medical students of Aristotle University of Thessaloniki. This questionnaire is going to be mailed to students and after asking their parents, they will be asked to complete it within a week and send it back). The type of questions included in the questionnaire is about at what age did you start controlling passing urine, stool during the day, night, about nocturnal enuresis, related family history and about existing of of incontince and voiding difficulties at present time. An individual needs about 30 minutes in order to complete it.
Intervention code [1] 286450 0
Not applicable
Comparator / control treatment
Single group trial
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288783 0
To assess if the process of maturation of sphincter control during childhood is associated with voiding habits during adult life. This is going to be assesed by completing a questionnaire. The questionnaire consists of three parts: a) demographic-somatometric data, b) information on the maturation process of sphincter control of both the students and their families and c) information about the voiding habits during adult life and their various disorders.
Timepoint [1] 288783 0
The questionnare is going to be completed by medical students of Aristotle University of Thessaloniki. This questionnaire is going to be mailed to students and after asking their parents, they will be asked to complete it within a week and send it back.
Secondary outcome [1] 300990 0
To assess if there is statistically significant correlation between nocturnal enuresis in students and their parents, impling genetic predisposition. This is going to be assesed by completing a questionnaire. The questionnaire consists of three parts: a) demographic-somatometric data, b) information on the maturation process of sphincter control of both the students and their families and c) information about the voiding habits during adult life and their various disorders.
Timepoint [1] 300990 0
The questionnare is going to be completed by medical students of Aristotle University of Thessaloniki. This questionnaire is going to be mailed to students and after asking their parents, they will be asked to complete it within a week and send it back.

Eligibility
Key inclusion criteria
Medical Students that can acquire information from their parents about their childhood urinary control habits.
Minimum age
18 Years
Maximum age
30 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
A chronic health problem affecting voiding habits (e.g neurologic disease, urogenital anomaly)

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment outside Australia
Country [1] 4836 0
Greece
State/province [1] 4836 0

Funding & Sponsors
Funding source category [1] 286673 0
Self funded/Unfunded
Name [1] 286673 0
Country [1] 286673 0
Greece
Primary sponsor type
Hospital
Name
Gennimatas General Hospital of Thessaloniki
Address
41 Ethnikis Aminis, Thessaloniki, 54643
Country
Greece
Secondary sponsor category [1] 285447 0
None
Name [1] 285447 0
Address [1] 285447 0
Country [1] 285447 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Nocturnal enuresis and delayed urinary control during childhood are common entities. Not every child is ready for complete urinary control by 5 years of age, and it is difficult to predict their ability to gain this control. It would seem to be a continuous developmental situation with most problems resolving as the child grows older. Often, it seems to be a family trait with a parent, brother or sister late in developing complete urinary control. It is also unknown the impact of these problems in adult life and possible association with pathologic urinary conditions. The purpose of this study is to answer some of these questions.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37594 0
Dr Kampantais Spyridon
Address 37594 0
41 Ethnikis Aminis Street, Thessaloniki, 54643
Country 37594 0
Greece
Phone 37594 0
+30 6945375525
Fax 37594 0
Email 37594 0
[email protected]
Contact person for public queries
Name 37595 0
Dr Kampantais Spyridon
Address 37595 0
41 Ethnikis Aminis Street, Thessaloniki, 54643
Country 37595 0
Greece
Phone 37595 0
+30 6945375525
Fax 37595 0
Email 37595 0
[email protected]
Contact person for scientific queries
Name 37596 0
Dr Kampantais Spyridon
Address 37596 0
41 Ethnikis Aminis Street, Thessaloniki, 54643
Country 37596 0
Greece
Phone 37596 0
+30 6945375525
Fax 37596 0
Email 37596 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.