Objective: 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 after 3 months. Design: RCT. Method: women with SUI and back pain associated with pregnancy that are in 3-6th month after their childbirth with desire to participate enter the study and are randomly divided into two groups of intervention or control. The assessment criteria in the first session, including the strength and endurance of the pelvic floor muscles through the vaginal examination, as well as applying the oswestry questionnaire to check the severity of disability caused by the back pain and UI questionnaire to examine the severity of urinary incontinence. 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. Interventions: 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. Primary outcome measures: pain, disability and severity of SUI.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017050618760N4
Registration date:2017-06-27, 1396/04/06
Registration timing:registered_while_recruiting
Last update:
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
2017-04-04, 1396/01/15
Expected recruitment end date
2017-12-21, 1396/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of stabilization exercises focusing on pelvic floor on stress urinary incontinence and low back pain in postpartum women
Public title
The effects of stabilization exercises focusing on pelvic floor on stress urinary incontinence and low back pain in postpartum women
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 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.
* The number of vaginal delivery and body mass index, as confounding factors, will be controlled and compared.
Age
From 15 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
37
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The randomization is by table of random numbers.
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
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
Intervention groups
1
Description
Intervention group: Progressive stabilization exercises focusing on pelvic floor daily and once a week under supervision of physiotherapist for 12 weeks
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
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
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
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
Tabriz university of medical science
Full name of responsible person
Fahime Khorasani
Position
MSC student of physiotherapy
Other areas of specialty/work
Street address
Tabriz university of medical science, Tabriz, East Azarbayjan, Iran
City
Tabriz
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
Other areas of specialty/work
Street address
Valieasr, North Tavanir, school of rehabilitation
City
Tabriz
Postal code
5157635411
Phone
+98 33311392
Fax
+41 33334647
Email
ghaderimailbox@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Fahime Khorasani
Position
MSC student of physiotherapy
Other areas of specialty/work
Street address
Iran, East Azarbayjan, North Tavanir, school of Rehabilitation
City
Tabriz
Postal code
5157635411
Phone
+98 33311392
Fax
+41 33334647
Email
Fahime_khorasani71@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)