Comparison the effect of Swiss ball and Kegel exercise on pelvic floor muscles strength and severity of urinary incontinence in women with multiple sclerosis
Comparison the effect of Swiss ball and Kegel exercise on pelvic floor muscles strength and severity of urinary incontinence in women with multiple sclerosis
Design
This study is a controlled clinical trial, single-blind and with parallel groups. 56 female MS patients with urinary incontinence will be randomly assigned to one of two groups:
G1(28Swiss ball);G2(28Kegel).
Settings and conduct
In this study among patients admitted to the MS socity of Ahvaz Golestan Hospital, their selection will be done based on inclusion criterai. All of the patients are blind to the randomization and are randomly allocated to one of the two groups: Intervention and control group .The intervention will be performed for 12 weeks in both groups. Evaluation with Pelvic floor muscles testing (By Prenometer) and ICIQ-UI SF questionnaire completion will be done for the two groups before intervention and at the end of the third month.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women with definitive diagnosis of MS; have symptoms of urinary incontinence; expanded disability status scale less than 5; being married; 18-45 years old; relapsing--remitting form of MS; no history of delivery during the last 6 months. Exclusion criteria: Severe cognitive problems; MS attack relapsed over the past three months; pregnancy; postmenopausal; urinary tract infection; having fatigue too; pelvic organ prolapse.
Intervention groups
Intervention : Swiss ball group
control:Kegel group
Comparison the effect of Swiss ball and Kegel exercise on pelvic floor muscles strength and severity of urinary incontinence in women with multiple sclerosis
Public title
The effect of exercise on urinary incontinence
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
women with definitive diagnosis of MS
Have symptoms of urinary incontinence
Expanded disability status scale (EDSS) score less than 5(According to the diagnosis of the neurologist)
Being married
18-45 years of age
Relapsing--remitting form of MS
No history of cesarean section or vaginal delivery during the last 6 months
Having the reading and writing literacy
Exclusion criteria:
Severe cognitive problems
MS attack relapsed over the past three months
pregnancy
Use diuretics and hypotensive drugs
postmenopausal
urinary tract infection
history of diabetes
Having fatigue too(increased muscle weakness)
pelvic organ prolapse and previous gynecological surgery
BMI Above 30
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 56 women with MS and urinary incontinence will be selected based on inclusion criteria. All of the patients are randomly assigned to one of the following two groups according to a computer-generated randomization list: G1 Swiss ball (n=28 ) and G2 Kegel exercise (n=28)
Blinding (investigator's opinion)
Single blinded
Blinding description
It is a single- blind study. In this study, the researcher after obtaining informed consent from the patients, will design two intervention groups for them.These two groups are: G1(Swiss ball) and G2(Kegel exercise), So 56 MS patients with urinary incontinence are randomly assigned to one of two groups and all of the patients are blind to the randomization.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University Of Medical Sciences and Health Services
Street address
Ahvaz Jundishapur University Of Medical Sciences and Health Services,Golestan Blvd, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2018-08-01, 1397/05/10
Ethics committee reference number
IR.AJUMS.REC.1397.312
Health conditions studied
1
Description of health condition studied
Multiple sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
Primary outcomes
1
Description
pelvic floor muscles strength
Timepoint
Before the start of the intervention and 12 weeks after the beginning of the exercises
Method of measurement
Perineometer
2
Description
urinary incontinence
Timepoint
Before the start of the intervention and 12 weeks after the beginning of the exercises
Method of measurement
ICIQ - UI SF questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: the Swiss ball group will perform pelvic floor muscle exercises with assistance of Swiss ball and in the rehabilitation clinic of Ahvaz University of Medical Sciences under the supervision of the researcher. These exercises will be performed three times per week for 12 weeks and each session lasts 45 minutes. All patients are evaluated and compared before the intervention and at the end of the third month. These evaluations are include: Pelvic floor muscles testing (By Prenometer) and ICIQ- UI SF questionnaire completion.
Category
Treatment - Devices
2
Description
Control group: In the Kegel group, the patients will be trained how to perform pelvic floor muscle exercises. These exercises are include: sleeping on the back with bended knees, Sitting and standing and will be done at home. These contractions start at 3 seconds and gradually takes up to 10 seconds. These exercises are performed three times per day for 12 consecutive weeks. All patients are evaluated and compared before the intervention and at the end of the third month. These evaluations are include: Pelvic floor muscles testing (By Prenometer) and ICIQ- UI SF questionnaire completion.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Khuozestan MS socity
Full name of responsible person
Nosrat Zaheryan
Street address
Khuozestan MS socity , School of Rehabilitation, Ahvaz Jundishapur University Of Medical Sciences, Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3374 3101
Fax
+98 61 3336 1984
Email
ms_ahwaz@yahoo.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr Mohammad Badvi
Street address
Ahvaz Jundishapur University Of Medical Sciences and Health Services,Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3336 1984
Fax
+98 61 3336 1984
Email
itc@ajums.ac.ir
Web page address
http://vchrducation.ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Nosrat Zaheryan
Position
Masters student Of Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School Of Nursing and Midwifery, Ahvaz Jundishapur University Of Medical Sciences, Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3446 2503
Fax
+98 61 3336 1984
Email
zaheryan_n@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Nosrat Zaheryan
Position
Masters student Of Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School Of Nursing and Midwifery, Ahvaz Jundishapur University Of Medical Sciences, Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3446 2503
Fax
+98 61 3336 1984
Email
zaheryan_n@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Nosrat Zaheryan
Position
Masters student Of Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School Of Nursing and Midwifery, Ahvaz Jundishapur University Of Medical Sciences, Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3446 2503
Fax
+98 61 3336 1984
Email
zaheryan_n@ajums.ac.ir
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
Undecided - It is not yet known if there will be 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