The effect of dynamic neuromuscular stabilization exercises on urinary incontinence in patients with multiple sclerosis
Design
In this study, due to the small number of samples, in consultation with a statistician, it was decided to use the random blocking method. Blocking is usually used to balance the number of samples assigned to each of the groups studied. The statistician used the website https://www.sealedenvelope.com/simple-randomiser/v1/lists, considering that we had 2 groups, to design a suitable blocking table. Divides patients according to this table is unaware of the study.
Settings and conduct
The place of this study is Isfahan, Ayatollah Kashani St., Kashani Hospital, physiotherapy ward and the time of its conduct is 2021.Study begins with obtaining permission from the ethics committee. Volunteers attend the physiotherapy department of Kashani Hospital. All stages of the work and the purpose of the research for patients are described in detail and the consent form is completed by them. In this study, patients are unaware of the groups. In both experimental and control groups, exercise therapy is performed, but the exercises are different.Also, the person doing the assessments is unaware of the groups.
Participants/Inclusion and exclusion criteria
Women diagnosed with multiple sclerosis (by a neurologist) who have urinary incontinence. Inclusion criteria include having a low disability to participate in the study and having at least one urinary incontinence in the past month. Exclusion from the study is other neurological diseases.
Intervention groups
In this study, the control group of Kegel exercises and the experimental group of dynamic neuromuscular stabilization receive.
Main outcome variables
Pelvic floor muscle strength, urinary incontinence, quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200101045970N5
Registration date:2021-10-27, 1400/08/05
Registration timing:registered_while_recruiting
Last update:2021-10-27, 1400/08/05
Update count:0
Registration date
2021-10-27, 1400/08/05
Registrant information
Name
Ehsan Ghasemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3669 3089
Email address
eghasemi@rehab.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-23, 1400/07/01
Expected recruitment end date
2022-03-16, 1400/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of dynamic neuromuscular stabilization exercises on stress and combined urinary incontinence in women with multiple sclerosis
Public title
The effect of stabilizing exercises on urinary incontinence in patients with MS
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women between the ages of 18 and 55.
Diagnosis of multiple sclerosis relapsing-remitting whose disease condition has stabilized (in the last 4 months. No change in symptoms)
According to the EDSS questionnaire, their disability should be less than or equal to 5.5.
Women who have experienced stress incontinence at least once in the past month.
Exclusion criteria:
Pregnancy
Existence of any neurological disease (except multiple sclerosis) or kidney disease
History of childbirth in the last 6 months
History of gastrointestinal surgery and abdominal surgery in less than 6 months
Infection of the lower urinary tract
Recurrence of the disease during the project
Existence of musculoskeletal pain such as back pain
Taking the drug for urinary incontinence (in case of discontinuation of the drug can be included in the study with the opinion of a doctor)
Being a virgin
Age
From 18 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, due to the small number of samples, in consultation with a statistician, it was decided to use the random blocking method. Blocking is usually used to balance the number of samples assigned to each of the groups studied. The statistician used the website https://www.sealedenvelope.com/simple-randomiser/v1/lists, considering that we had 2 groups, to design a suitable blocking table. Divides patients according to this table is unaware of the study.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, patients are unaware of the groups. In this study, exercise therapy is presented in both experimental and control groups, but they are different. In this study, patients try to come at different times and do not even contact each other so that they do not know the details of each other's exercises. Also, the person doing the assessments is unaware of the groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Faculty of Nursing, Management and Rehabilitation - Isfahan University of Medical Sciences (Research
Street address
Hezar Jirib
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2021-10-01, 1400/07/09
Ethics committee reference number
IR.MUI.NUREMA.REC.1400.130
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 muscle strength
Timepoint
Before treatment, after 3 weeks from the beginning of the sessions, after the end of the sessions and 2 months after the end of the last treatment session
Method of measurement
The modified Oxford Scale, a 6-point scale, is used to assess pelvic floor muscle strength.
2
Description
The rate of urinary incontinence
Timepoint
Before treatment, after 3 weeks from the beginning of the sessions, after the end of the sessions and 2 months after the end of the last treatment sessio
Method of measurement
The severity index of urinary incontinence in women is used to assess the rate of urinary incontinence
Secondary outcomes
1
Description
Quality of Life
Timepoint
Before treatment, after 3 weeks from the beginning of the sessions, after the end of the sessions and 2 months after the end of the last treatment session
Method of measurement
The LUTS-QOL questionnaire is used to assess the effect of urinary incontinence on the quality of life of these people.
Intervention groups
1
Description
Intervention group: Receive dynamic neuromuscular stabilization exercises. These exercises are performed in different positions that are actually modeled on the positions of the growing baby. Exercises start with simple situations and gradually become more complex. In fact, the exercises start with the supine and then progress to the rolling, sitting, bear and squat-like postures. The workout lasts for 6 weeks. The patient goes to physiotherapy twice a week.
Category
Rehabilitation
2
Description
Control group: Receive Kegel exercises. This exercise involves the patient contracting the pelvic floor muscles under the supervision of a therapist. In each session, moderate and intense exercises are performed. Moderate-intensity exercises last between 6 and 10 seconds, and high-intensity exercises last between 1 and 3 seconds. The exercises start from the supine position and are gradually taught in different positions such as sitting and standing. The patient is treated twice a week for 6 weeks.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashani Hospital
Full name of responsible person
Ehsan Ghasemi
Street address
kashani
City
Isfahan
Province
Isfehan
Postal code
8183983434
Phone
+98 31 3233 0091
Fax
Email
kashani@mui.ac.ir
Web page address
https://kashani.mui.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
shaghayegh haghjoo
Street address
Hezar Jreeb
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 7898
Email
research@mui.ac.ir
Web page address
https://research.mui.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Ehsan Ghasemi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Hezar Jreeb
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3669 3089
Email
eghasemi@rehab.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ehsan Ghasemi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Hezar Jreeb
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3669 3089
Email
eghasemi@rehab.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ehsan Ghasemi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Hezar Jreeb
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3669 3089
Email
eghasemi@rehab.mui.ac.ir
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
Because of confidentiality
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
-
When the data will become available and for how long
-
To whom data/document is available
-
Under which criteria data/document could be used
-
From where data/document is obtainable
-
What processes are involved for a request to access data/document