Aim: Efficacy and comparing of biofeedback and combination biofeedback with abdominal exercise in stress incontinence in grade 2 - 4 score urinary incontinence.
Methods: 60 subject with stress incontinence will be selected. They will be divided in two group. One group will be treated with electromyography biofeedback and the other group will receive biofeedback with abdominal exercise. Before and after 3 month, they will be evaluated with muscle test and self-administration international consultation incontinence quastionnaire (ICIQ).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201506246083N9
Registration date:2015-07-21, 1394/04/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-07-21, 1394/04/30
Registrant information
Name
Abbas Ali Pourmomeny
Name of organization / entity
School of Rehabilitation Sciences, Isfahan University of Medical Sciences, Isfahan, Iran
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 2024
Email address
pourmomeny@rehab.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Department of physical therapy, School of Rehabilitation Sciences, Isfahan University of Medical Sciences
Expected recruitment start date
1993-01-01, 1371/10/11
Expected recruitment end date
1995-01-01, 1373/10/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the efficacy of biofeedback and exercise in treatment urinary incontinence
Public title
Efficacy of biofeedback in urinary incontinence
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: stress incontinence; age more than 18 years. Exclusion criteria: history of surgery in pelvic organ
Age
From 18 years old to 70 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences
City
Isfahan
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
4/ 10 / 93 - 262 / م / پ
Health conditions studied
1
Description of health condition studied
incontinence
ICD-10 code
N39.3
ICD-10 code description
Stress incontinence
Primary outcomes
1
Description
muscle test
Timepoint
before and after treatment
Method of measurement
Physical examination
2
Description
Questionnaire(ouality of life)
Timepoint
before & after
Method of measurement
Questionnaire (ICIQ)
Secondary outcomes
empty
Intervention groups
1
Description
group 1:biofeedback therapy
Category
Rehabilitation
2
Description
group2: biofeedback with abdominal exercise
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of physical therapy, School of Rehabilitation Sciences, Isfahan University of Medical Sci
Full name of responsible person
Abbas ali Pourmomeny
Street address
Department of physical therapy, School of Rehabilitation Sciences,Hazar garib Ave. Isfahan University of Medical Sciences
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Isfahan University of Medical Sciences
Full name of responsible person
Peyman Adibi
Street address
Vice Chancellor for research of Isfahn University of Medical Sciences - Hazargrib Ave. Isfahan University
City
Isfahan
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 of Isfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Department of physical therapy, School of Rehabilitation Sciences, Isfahan University of Medical Sci
Full name of responsible person
Abbas Ali Pourmomeny
Position
PhD
Other areas of specialty/work
Street address
Department of physical therapy, School of Rehabilitation Sciences, Hazar grib Ave. Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 31 3792 2024
Fax
Email
pourmomeny@rehab.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of physical therapy, School of Rehabilitation Sciences, Isfahan University of Medical Sci
Full name of responsible person
Abbas Ali Pourmomeny
Position
PhD
Other areas of specialty/work
Street address
Department of physical therapy, School of Rehabilitation Sciences, Isfahan University of Medical Sciences, Hazar grib Ave.
City
Isfahan
Postal code
Phone
+98 31 3792 2024
Fax
Email
pourmomeny@rehab.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)