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General information
2017-04-04, 1396/01/15
2017-07-06, 1396/04/15
2017-0407-0406 00:00:00
Protocol summary
Study aim
The aim of this study is to evaluate the effect of stabilization exercises focusing on pelvic floor on stress urinary incontinence and low back pain in postpartum women.
Design
Single-blind randomised linical trial with control group, community-based and pragmatic with parallel groups
Settings and conduct
This study was carried out with the participation of 80 women, aged 20 to 45 years old. The presence of SUI and mechanical LBP was verified by a gynecologist and a physiotherapist, respectively.
The eligible women were randomly assigned to control and intervention groups using Random Allocation Software (RAS). Allocation was blind and done by a third person. The evaluation was carried out at the beginning and the end of the study by a physiotherapist who was not involved in the research and was blind to allocation. In the intervention group, women participated in a 12-week program that involved performing a home based progressive stabilization exercises focusing on pelvic floor. The control group did not receive any treatment.
Place of study: Al-Zahra Hospital in Tabriz
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women who lived in Tabriz experienced stress urinary incontinence and back pain after 3-6 months of natural childbirth. Exclusion criteria: Caesarean section; urogenital diseases or infections; receiving other treatments for SUI or back pain; history of pelvic floor or spinal surgeries; malignancies; pelvic or spinal fractures; having twins or multiple children; specific low back pain; severe urinary incontinence.
Intervention groups
After initial assessment through the mentioned instruments, women of the intervention group received an exercise program focusing on pelvic floor muscles for 12 weeks. Women in the control group will not receive any treatment.
Main outcome variables
Pain; disability; urinary incontinence severity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT2017050618760N4
Registration date:2017-06-27, 1396/04/06
Registration timing:registered_while_recruiting
Last update:2019-04-11, 1398/01/22
Update count:2
Registration date
2017-06-27, 1396/04/06
Registrant information
Name
Fariba Ghaderi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1333 4647
Email address
ghaderif@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Tabriz University of Medical Sciences
Expected recruitment start date
2017-07-06, 1396/04/15
Expected recruitment end date
2017-12-21, 1396/09/30
Actual recruitment start date
2017-04-04, 1396/01/15
Actual recruitment end date
2017-12-21, 1396/09/30
Trial completion date
2017-12-21, 1396/09/30
Scientific title
Effects of stabilization exercises focusing on pelvic floor on postnatal Stress urinary incontinence and low back pain
Public title
Effects of stabilization exercises focusing on pelvic floor on postnatal Stress urinary incontinence and low back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women who lived in Tabriz experienced stress urinary incontinence and back pain after 3-6 months of natural childbirth. The urinary incontinence and back pain of pregnancy are those that start during the pregnancy period or after the childbirth.
Exclusion criteria:
Caesarean section
urogenital diseases or infections
receive other treatments for SUI or LBP
history of pelvic floor or spinal surgeries
malignancies
pelvic or spinal fractures
having twins or multiple children
specific low back pain
severe urinary incontinence
LBP or UI before pregnancy
Age
From 20 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
38
Actual sample size reached:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done through Random Allocation software (RAS).
Blinding (investigator's opinion)
Single blinded
Blinding description
Women's assessment at the beginning and end of the study will be conducted by a physiotherapist who is not present in the training process and is blind to women's allocation.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Vice Chancellor for Research of Tabriz University of Medical Science
Street address
Tabriz, daneshgah square, tabriz university of medical science
City
Tabriz
Province
East Azarbaijan
Postal code
5157635411
Approval date
2017-04-24, 1396/02/04
Ethics committee reference number
IR.TBZMED.REC.1396.65
Health conditions studied
1
Description of health condition studied
Stress urinary incontinence
ICD-10 code
N39.3
ICD-10 code description
Stress incontinence
2
Description of health condition studied
Low back pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain
Primary outcomes
1
Description
disability
Timepoint
Beginning and end of the study with an interval of 12 weeks
Method of measurement
Oswestry questionnaire
2
Description
Pain
Timepoint
Beginning and end of the study with an interval of 12 weeks
Method of measurement
VAS scale
3
Description
Intensity of stress urinary incontinence
Timepoint
Beginning and end of the study with an interval of 12 weeks
Method of measurement
Urinary incontinence questionnaire
Secondary outcomes
1
Description
strength of pelvic floor muscles
Timepoint
Beginning and end of the study with an interval of 12 weeks
Method of measurement
Manual muscle testing
2
Description
Endurance of pelvic floor muscles
Timepoint
Beginning and end of the study with an interval of 12 weeks
Method of measurement
Manual muscle testing
3
Description
strength of transverse abdominis
Timepoint
Beginning and end of the study with an interval of 12 weeks
Method of measurement
Pressure Biofeedback
Intervention groups
1
Description
Intervention group: women participated in a 12-week program that involved performing a home based progressive stabilization exercises focusing on pelvic floor. The first session was for educating the correct contraction of transverse abdominis muscle using pressure biofeedback and PFM contraction using vaginal examination. Pamphlet and a video CD were given to all participants in this group and the exercises were monitored weekly through telephone interviews. Each week, permission to start new exercises was given only if the participant had no problem performing the previous exercise.
Category
Rehabilitation
2
Description
Control group: no treatment
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra hospital in Tabriz
Full name of responsible person
Fahime Khorasani
Street address
Tabriz, Baghshomal four-way, Al-Zahra hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5138663134
Phone
+98 41 3553 9161
Email
alzahrahosp@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Tabriz University of Medical Sciences
Full name of responsible person
Dr Mohamad Reza Rashidi
Street address
Tabriz university of medical science, Tabriz, East Azarbayjan, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5138663134
Phone
+98 41 3334 4280
Email
research-vice@tbzmed.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 of Tabriz 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
Tabriz university of medical science
Full name of responsible person
Fahime Khorasani
Position
MSC student of physiotherapy
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Tabriz university of medical science, Tabriz, East Azarbayjan, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5157635411
Phone
+98 41 3331 1293
Fax
+98 41 3333 4647
Email
Fahime_khorasani71@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz university of medical sciences
Full name of responsible person
Dr. Fariba Ghaderi
Position
Phd of physiotherapy
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Valieasr, North Tavanir, school of rehabilitation
City
Tabriz
Province
East Azarbaijan
Postal code
5157635411
Phone
+98 33311392
Fax
Email
ghaderimailbox@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz university of medical sciences
Full name of responsible person
Fahime Khorasani
Position
MSC student of physiotherapy
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Iran, East Azarbayjan, North Tavanir, school of Rehabilitation
City
Tabriz
Province
East Azarbaijan
Postal code
5157635411
Phone
+98 33311392
Fax
Email
Fahime_khorasani71@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD