Objective: Determine the effect of pelvic floor muscle training for urinary incontinence and quality of life in patients with multiple sclerosis. Design: This study is a clinical trial, quasi-experimental , before and after. How to do: The study included 50 male and female patients with multiple sclerosis MS clinic of Imam Khomeini Hospital in Tehran that the patient will be done after obtaining written consent. Sampling methods are available . Before the intervention, demographic questionnaire , urinary incontinence, quality of life and Depression, Anxiety and Stress will be completed . Patients in relation to the pelvic floor muscles will be trained by the researcher . The exercises 3 times a day for 12 consecutive weeks will be patient at first contraction for 3 seconds and subsequent 5 seconds sleep then gradually term contractions increase and the number of contractions to 90 to 100 contractions per day will brings. Educational pamphlets regarding urinary incontinence and pelvic floor muscle training in multiple sclerosis and its Czech list report will be given to patients . Patient questionnaires for urinary incontinence and quality of life will be complete by the end of the third month. During the study, researcher will attend one day a week at the MS Clinic and per week in the first month, the second month and the third month following the end of the telephone with the patient will be contacted.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014010416063N1
Registration date:2014-03-25, 1393/01/05
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-03-25, 1393/01/05
Registrant information
Name
Habib Shareinia
Name of organization / entity
Gonabad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 53 3722 9878
Email address
h-shareinia@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2014-02-17, 1392/11/28
Expected recruitment end date
2014-07-21, 1393/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of pelvic floor muscle exercise training on urinary incontinence and quality of life in patients with multiple sclerosis
Public title
The effect of pelvic floor muscle exercises on urinary incontinence and quality of life in patients with multiple sclerosis
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
The risk of urinary incontinence due to multiple sclerosis according to the neurologist diagnosed , having a degree of disability (EDSS: Expanded disability status scale) is less than 7 according to the diagnosis of neurologist, literacy , age 50-18 years , no severe cognitive problems , lack of patient suffering from the disease attacks during the past three months , the patient is not pregnant, the unchanged drug effects on urinary incontinence if you take a month before the study , no use of diuretics and antihypertensive drugs , lack of chronic heart and lung disease , no menopause , no urinary tract infection , history of diabetes , history of prostate and gynecologic surgery , no history of cesarean section or vaginal delivery during the last six months .
Exclusion criteria : Unwillingness to continue participation in the study for any reason, an acute medical condition during the study, to develop an acute attack of the disease, having an excessive fatigue so that the patient can not exercise and the patients drugs affecting urinary incontinence it is changed during the study.
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Sixth Floor, Central Organization of University, Qods St, Keshavarz Blvd
City
Tehran
Postal code
Approval date
2014-02-17, 1392/11/28
Ethics committee reference number
130/2715/د/92
Health conditions studied
1
Description of health condition studied
urinary incontinence
ICD-10 code
N39.4
ICD-10 code description
Other specified urinary incontinence
Primary outcomes
1
Description
Urinary incontinence
Timepoint
Before training and after three months of training
Method of measurement
Questionnaire ICIQ-UI SF
Secondary outcomes
1
Description
Quality of life
Timepoint
Before training and after three months of training
Method of measurement
Questionnaire Qualiveen
2
Description
Stress, Anxiety and Depression
Timepoint
Before training and three months After training
Method of measurement
Questionnaire DASS-21
Intervention groups
1
Description
Patients in relation to the pelvic floor muscles will be trained by the researcher. The exercise consists of a series of pelvic floor muscle contractions in different modes, including lying on his back with knees bent, sitting and standing which patients will be advised at the beginning of the contraction for 3 seconds, followed by 5 seconds of rest have done and duration of contractions gradually increased to reach 10 seconds. The exercises 3 times a day for 12 consecutive weeks and will increase gradually until contractions reached 90 to 100 contractions per day.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
MS clinic of Imam Khomeini Hospital in Tehran
Full name of responsible person
Habib Shareinia
Street address
Imam Khomeini Hospital, Dr Mirkhani St, Tohid Sq
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Council of Tehran University of Medical Sciences
Full name of responsible person
Doctor Masood Younesian - Vice President of Research and Technology
Street address
Keshavarz St, Qods St., Central Building, Sixth Floor, Tehran University of Medical Sciences, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Council of Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Habib Shareinia
Position
Nursing Graduate Student
Other areas of specialty/work
Street address
School of Nursing and Midwifery Tehran University of Medical Sciences, Dr Mirkhani St, Tohid Sq Tehran
City
Tehran
Postal code
Phone
+98 21 6692 7171
Fax
Email
shareinia.msn@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Doctor Forough Rafii
Position
PhD in Nursing-Associate Professor
Other areas of specialty/work
Street address
School of Nursing and Midwifery Iran University of Medical Sciences, Vali Asr St, Vanak Sq , Rashid Yasami St
City
Tehran
Postal code
Phone
+98 21 8888 2886
Fax
Email
foroughrafii@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Habib Shareinia
Position
Nursing Graduate Student
Other areas of specialty/work
Street address
School of Nursing and Midwifery Tehran University of Medical Sciences, Dr Mirkhani St, Tohid Sq Tehran
City
Tehran
Postal code
Phone
00
Fax
Email
shareinia.msn@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)