The effect of dynamic stabilization exercises on emergency urinary incontinence and quality of life in patients with multiple sclerosis
Design
Clinical trial with control group, with parallel groups, double-blind, randomized
Settings and conduct
Women with a diagnosis of multiple sclerosis (by a neurologist) who have urinary incontinence are referred to the physiotherapy department of Kashani Hospital for inclusion in the study.Patients are then randomly assigned to two groups. Patients do not know which group they or other patients belong to.One group receives Kegel exercises and the other group receives dynamic neuromuscular stabilization exercises.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women between the ages of 18 and 55 with a diagnosis of multiple sclerosis whose disease status is stable.
Exclusion criteria: other neurological diseases.
Intervention groups
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. In each training session, 3 different situations are taught. Each exercise is maintained 3 times for 10 seconds and the patient is given 10 seconds of rest between each.
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 exercise lasts between 6 and 10 seconds, and high-intensity exercise lasts between 1 and 3 seconds. The rest period between two contractions lasts between 1 and 12 seconds.
Both groups go to physiotherapy for 6 weeks and twice a week for training and exercises under the supervision of a physiotherapist.
Main outcome variables
Pelvic floor muscle strength, urinary incontinence and quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200101045970N6
Registration date:2022-05-29, 1401/03/08
Registration timing:prospective
Last update:2022-05-29, 1401/03/08
Update count:0
Registration date
2022-05-29, 1401/03/08
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
2022-06-20, 1401/03/30
Expected recruitment end date
2022-09-20, 1401/06/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of dynamic neuromuscular stabilization exercises on overactive bladder and quality of life in women with multiple sclerosis
Public title
Evaluation of exercise therapy on quality of life in patients with multiple sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of relapsing-remitting multiple sclerosis whose disease condition has stabilized (in the last 4 months. No change in symptoms)
According to the Expanded Disability Status Scale (EDSS) questionnaire, their disability should be less than or equal to 5.5.
Women who have experienced emergency incontinence at least once in the past month.
Exclusion criteria:
Pregnancy
Presence 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
Existence of musculoskeletal pain such as back pain
Taking the drug for urinary incontinence (in case of discontinuation of the drug with the opinion of a doctor can be included in the study)
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, patients are randomly divided into one of two experimental and control groups after examining the inclusion and exclusion criteria. 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, they designed 15 two-person blocks. . A person who divides patients into two groups based on 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
Ethics Committee of the School of Nursing, Management and Rehabilitation - Isfahan University of Med
Street address
Vice Chancellor for Research and Technology, Building No. 4, Isfahan University of Medical Sciences and Health Services, Hezar Jerib St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2022-04-08, 1401/01/19
Ethics committee reference number
IR.MUI.NUREMA.REC.1401.028
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
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 Lower urinary tract symptom-quality of life questionnaire is used to assess the effect of urinary incontinence on the quality of life of these people.
Secondary outcomes
1
Description
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
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. In each training session, 3 different situations are taught. Each exercise is maintained 3 times for 10 seconds and the patient is given 10 seconds of rest between each. The workout lasts for 6 weeks. The patient goes to physiotherapy twice a week.
Category
Rehabilitation
2
Description
Control group: Receive Kegel exercises. Kegel exercises strengthen the pelvic floor muscles, which support the uterus, bladder, small intestine and rectum.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
Isfahan Kashani Hospital
Full name of responsible person
Ehsan Ghasemi
Street address
Ayatollah Kashani Hospital, Main Street of Ayatollah Kashani
City
Isfahan
Province
Isfehan
Postal code
8183983434
Phone
+98 31 3233 0091
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
Mansour Siavash Dastjerdi
Street address
Vice Chancellor for Research and Technology, Building No. 4, Isfahan University of Medical Sciences and Health Services, Hezar Jerib St.
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
Faculty of Rehabilitation Sciences, Isfahan University of Medical Sciences and Health Services, Hezar Jerib St.
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
Faculty of Rehabilitation Sciences,Isfahan University of Medical Sciences and Health Services, Hezar Jerib St.
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
Faculty of Rehabilitation Sciences, Isfahan University of Medical Sciences and Health Services, Hezar Jerib St.
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
Study protocol, informed consent form and clinical study report
When the data will become available and for how long
The study protocol and consent form are now available in the proposal. The clinical study report will be published after the work is completed.
To whom data/document is available
All researchers working in scientific institutes can access the proposal.
Under which criteria data/document could be used
To be aware of the study conditions and get acquainted with scientific concepts.
From where data/document is obtainable
Contact Dr. Ehsan Ghasemi via email or mobile.
What processes are involved for a request to access data/document
Immediately after sending the email and receiving the request.