Comparison of the Effects of Isolated Pelvic Floor Muscles Training, Deep Abdominal Muscles Training and Their Combination in Quality of Life of Females with Stress Urinary Incontinence.
The aim of this study is to investigate the effects of pelvic floor muscles (PFM) training, deep abdominal muscles training and their combination on the quality of life of females with stress urinary incontinence (SUI). This study is a double – blind (subjects and examiners), randomized controlled trial. 54 females with SUI will be included in this study. Subjects will be excluded if they have a history of surgery involving the pelvic floor; neurological or psychiatric disease or a major medical condition, current pregnancy or less than 3 months postpartum and prolapse. Patients will be randomly assigned into 3 treatment groups; the first group receives a conventional treatment with focus of the PFM, the second group will perform only transverse abdominal (TrA) muscle exercises and third; cocontraction of both PFM and TrA. Exercises progress from simple to functional. Physiotherapist will instruct and monitor exercises 1 day a week and will check exercises using telephone calls twice a week for 8 weeks. To record the quality of life, Incontinence Quality of Life (I-QOL) Questionnaire and to access maximal voluntary contraction (MVC) and endurance of pelvic floor muscles perinometer will be used before and after treatment interventions. Main outcome measures such as I-QOL scale, MVC and endurance of PFM will be reported.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017082218362N2
Registration date:2017-10-19, 1396/07/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-10-19, 1396/07/27
Registrant information
Name
Fateme Esfandiarpour
Name of organization / entity
School of Rehabilitation Sciences,Ahvaz Jundishupur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61337431013 ext. 259
Email address
esfandiarpour_f@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2017-07-24, 1396/05/02
Expected recruitment end date
2017-09-21, 1396/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effects of Isolated Pelvic Floor Muscles Training, Deep Abdominal Muscles Training and Their Combination in Quality of Life of Females with Stress Urinary Incontinence.
Public title
Comparison of the Effects of Isolated Pelvic Floor Muscles Training, Deep Abdominal Muscles Training and Their Combination in Management of Stress Urinary Incontinence.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Females with SUI in the age range of 18-60 years will be included in this study if they have complaint of involuntary leakage of urine on effort or on sneezing or coughing. Exclusion Criteria: Subjects will be excluded if they have a history of surgery involving the pelvic floor; neurological or psychiatric disease or a major medical condition; current pregnancy or less than 3 months postpartum; prolapse; severe low back pain or pelvic pain; ongoing urinary tract infections and undergoing concurrent treatment for SUI.
Age
From 18 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Table of random numbers will be used to simply assign the subjects in three groups of treatment. The examiner will not be aware of which intervention will be administered to which subject. The patients do not aware of other groups.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Central Office, University Campus, Golestan
City
Ahvaz
Postal code
Approval date
2017-07-22, 1396/04/31
Ethics committee reference number
IR.AJUMS.REC.1396.453
Health conditions studied
1
Description of health condition studied
stress urinary incontinence
ICD-10 code
N39.3
ICD-10 code description
Stress incontinence
Primary outcomes
1
Description
Incontinence Quality of Life Questionnaire scale
Timepoint
Before and after treatment interventions
Method of measurement
Incontinence Quality of Life Questionnaire
Secondary outcomes
1
Description
maximal voluntary contraction of pelvic floor muscles
Timepoint
Before and post treatment intervention
Method of measurement
perinometer
2
Description
endurance of pelvic floor muscles
Timepoint
Before and post treatment intervention
Method of measurement
perinometer
Intervention groups
1
Description
Intervention 1: Participants in the pelvic training group will be instructed to contract PFM .Vaginal palpation will be applied for the valid evaluation of vaginal squeeze pressure. Contraction of PFM will be progressed by positioning in: 1st session: crook; 2nd: supine; 3rd: side lying; 4th: sitting; 5th: standing; 6th, 7th: walking and last: ADL. Individuals will meet physiotherapist once a week to be instructed new exercise and physiotherapist will check exercises using telephone calls twice a week for 8 weeks. Participants will perform exercises 3 sets, 2 times a day .Each set contains 10 repetition of isolated MVC of PFM as long as possible (maximum: 10 seconds) and 5 fast contraction(contraction: 1 second, rest:1second).
Category
Rehabilitation
2
Description
Intervention 2: Participants in the deep abdominal muscles training group will be instructed to contract Transversus Abdominis. Contraction of TrA will be progressed by positioning in: 1st session: crook; 2nd: crook with flexion and extension of knee; 3rd: crook with flexion and extension of shoulder; 4th: sitting; 5th: standing; 6th, 7th: walking and last: ADL. Individuals will meet physiotherapist once a week to be instructed new exercise and physiotherapist will check exercises using telephone calls twice a week for 8 weeks. Participants will perform exercises 3 sets, 2 times a day .Each set contains 10 repetition of isolated maximum voluntary contraction of TrA as long as possible (maximum: 10 seconds) and 5 fast contraction (contraction: 1 second, rest:1second ).
Category
Rehabilitation
3
Description
Intervention 3 : Participants in the combination of pelvic and abdominal muscles training group will be instructed to contract PFM and TrA. Vaginal palpation will be applied for the evaluation of vaginal squeeze pressure. Cocontraction of PFM and TrA will be progressed by positioning in: 1st session: crook; 2nd: supine; 3rd: side lying; 4th: sitting; 5th: standing; 6th, 7th: walking and last: ADL. Individuals will meet physiotherapist once a week to be instructed new exercise and physiotherapist will check exercises using telephone calls twice a week for 8 weeks. Participants will perform exercises 3 sets, 2 times a day .Each set contains 10 repetition of isolated maximum voluntary Cocontraction of PFM and TrA as long as possible (maximum: 10 seconds) and 5 fast contraction (contraction: 1 second, rest:1second ).
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Rehabilitation Clinics of School of Rehabilitation Sciences, Ahvaz Jundishapur University of Medica
Full name of responsible person
Dr. Fateme Esfandiarpour
Street address
School of Rehabilitation Sciencesُ, University Campus, Golestan
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences, Vice Chancellor for Research Development and Techn
Full name of responsible person
Dr. Behzad Sharif Makhmalzadeh
Street address
The office of Vice Chancellor for Research Development and Technology, University Campus, Golestan
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundishapur University of Medical Sciences, Vice Chancellor for Research Development and Techn
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
Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
Full name of responsible person
Dr. Fateme Esfandiarpour
Position
Assistant Professor, Ph.D. in Physical Therapy
Other areas of specialty/work
Street address
School of Rehabilitation Sciences, University Pardis, Golestan
City
Ahvaz
Postal code
Phone
+98 61 3374 3108
Fax
Email
esfandiarpour_f@ajums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
Full name of responsible person
Dr. Fateme Esfandiarpour
Position
Assistant Professor, Ph.D. in Physical Therapy
Other areas of specialty/work
Street address
School of Rehabilitation Sciences, University Pardis, Golestan
City
Ahvaz
Postal code
Phone
+98 61 3374 3108
Fax
Email
esfandiarpour_f@ajums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishupur University of Medical Sciences, Ahvaz, Iran
Full name of responsible person
Zahra Sarikhani
Position
MSc. Student in Physical Therapy
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
sarikhanyz@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)