Determine the effect of behavioral interventions program on urinary incontinence in the elderly in Urmia
Design
quasi-experimental type with the design of before and after intervention
Settings and conduct
A Quasi-Experimental Study on Elderly Men in Urmia Elderly Centers
Participants/Inclusion and exclusion criteria
Elderly men with with acute urinary incontinence
Intervention groups
The intervention included pelvic floor and bladder exercises and lifestyle modification training, individually.
Main outcome variables
The frequency of urinary leakage
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180808040742N2
Registration date:2019-10-28, 1398/08/06
Registration timing:retrospective
Last update:2019-10-28, 1398/08/06
Update count:0
Registration date
2019-10-28, 1398/08/06
Registrant information
Name
Yaser Moradi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3336 7978
Email address
y.moradi@edu.umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-07-12, 1396/04/21
Expected recruitment end date
2017-10-05, 1396/07/13
Actual recruitment start date
2017-08-06, 1396/05/15
Actual recruitment end date
2017-11-16, 1396/08/25
Trial completion date
2018-05-01, 1397/02/11
Scientific title
Determining the Effect of the Pelvic Floor Muscles Training, Bladder Exercises, and Lifestyle Modification on the Urinary Incontinence in Elderly Men
Public title
The effect of behavioral interventions program on urinary incontinence in the elderly
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Elderly men with urinary incontinence who their disease certainly was diagnosed by a physician.
Not using the urinary catheter
They had the cognitive ability to receive the training.
They had the possibility of mobility and going to the toilet alone or needed the least help.
Exclusion criteria:
Age
From 60 years old to 80 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Actual sample size reached:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Quasi-experimental type with the design of before and after intervention
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee of Urmia University of Medical
Street address
Resalat Boulevard,Vice-chancellor for research of Urmia University of Medical Sciences
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2017-04-21, 1396/02/01
Ethics committee reference number
IR.UMSU.REC.1391.31
Health conditions studied
1
Description of health condition studied
Urinary Incontinence
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The frequency of urinary leakage
Timepoint
At the beginning of the study and after its completion
Method of measurement
The standard ICIQ-SF questionnaire
Secondary outcomes
1
Description
Urinary leakage rate
Timepoint
At the beginning of the study and after its completion
Method of measurement
The standard ICIQ-SF questionnaire
Intervention groups
1
Description
Intervention group: The intervention included pelvic floor and bladder exercises and lifestyle modification training, individually.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
مراکز سالمندان شهر ارومیه
Full name of responsible person
Yaser Moradi
Street address
Farhangh street, first 16 meters, P20
City
Urmia
Province
West Azarbaijan
Postal code
9842563214
Phone
+98 44 3336 7978
Email
yasermoradi1045@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Vice-chancellor for research
Street address
Vice chancellor for research, Urmia University of Medical Sciences, Resalat Boulevard, Urmia, Iran
City
Urmia
Province
West Azarbaijan
Postal code
9842563214
Phone
+98 44 3336 7978
Email
yasermoradi1045@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Yaser Moradi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Farhangh street, first 16 meters, P20
City
Urmia
Province
West Azarbaijan
Postal code
9842563214
Phone
+98 44 3336 7978
Email
yasermoradi1045@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Yaser Moradi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Farhangh street, first 16 meters, P20
City
urmia
Province
West Azarbaijan
Postal code
9842563214
Phone
+98 44 3336 7978
Email
yasermoradi1045@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Yaser Moradi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Farhangh street, first 16 meters, P20
City
Urmia
Province
West Azarbaijan
Postal code
9842563214
Phone
+98 44 3339 7978
Email
yasermoradi1045@yahoo.com
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
No - There is not 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