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The effect of eight weeks of yoga training program on pelvic floor muscle strength, bladder neck descent,urinary control, urogenital hiatus diameter and urethral rotation angles in female athletes with stress urinary incontinence due to training intensity.

Protocol summary

Study aim
Investigating the effect of eight weeks of yoga training program on muscle strength,bladder neck descent,urinary control and hiatus diameter, urethral rotation angles in female athletes
Design
After the evaluation according to the entry criteria, 20 people were selected for this study and then randomly divided into two control and experimental groups. People in the experimental group will continue their routine for eight weeks of practice and control.
Settings and conduct
Examination of the severity and type of urinary incontinence and quality of life with ICIQ-UI-SF, IQOL questionnaires and assessment of bladder neck descent and hiatus diameter and urethral rotation angles with ultrasound, assessment of pelvic floor muscle strength by clinical assessment of vaginal palpation by a gynecologist in Taleghani Hospital Tehran was done..
Participants/Inclusion and exclusion criteria
Entry: Female aged 20-35 suffering from stress urinary incontinence with a history of sports. not entering: diabetes, urinary tract infection, eating disorders. Pregnancy less than ten years,
Intervention groups
Experimental group (yoga exercises): After evaluating the patients, 10 people were selected for this group and after obtaining a written consent and information form including age and sports history, among these people, pre-tests of the ICIQ-UI-SF questionnaire and IQOL, ultrasound and vaginal touch evaluation will be done from them, and after eight weeks, the post-test exercise will be done like the pre-test. Written letter and information form including age and sports history, etc., of these people, pre-tests of ICIQ-UI-SF and IQOL questionnaires, ultrasound and vaginal palpation evaluation will be done from them and finally the post-test will be done
Main outcome variables
Urinary control intensity, bladder neck descent, hiatus diameter, urethral rotation angles, pelvic floor muscle strength.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230113057119N1
Registration date: 2023-03-04, 1401/12/13
Registration timing: retrospective

Last update: 2023-03-04, 1401/12/13
Update count: 0
Registration date
2023-03-04, 1401/12/13
Registrant information
Name
Maryam Shirzad
Name of organization / entity
Shahid Rajaee Teacher Training University
Country
Iran (Islamic Republic of)
Phone
+98 21 2250 0149
Email address
maryam90_sh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-16, 1401/10/26
Expected recruitment end date
2023-02-15, 1401/11/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of eight weeks of yoga training program on pelvic floor muscle strength, bladder neck descent,urinary control, urogenital hiatus diameter and urethral rotation angles in female athletes with stress urinary incontinence due to training intensity.
Public title
The effect of yoga training program on pelvic floor muscle strength, bladder neck descent,urinary control, urogenital hiatus diameter and urethral rotation angles in female athletes with stress urinary incontinence due to training intensity.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
be a woman Suffering from stress urinary incontinence Sports history Have not done yoga for at least six months
Exclusion criteria:
Having diabetes Lack of cooperation smoking urinary tract infection hormonal drugs Menopause high BMI taking contraceptives eating disorders pregnancy less than ten years and more than twice history of pelvic floor surgery in the previous year pelvic pain in digital examination
Age
From 20 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 20
Randomization (investigator's opinion)
Randomized
Randomization description
Simple random - lottery (in this method, the researcher gives a code or a special number to each member of the society. Then he writes down the number of each of them on a piece of paper, then he pours them into a container and shakes them. Then the papers are separated one by one. take them out, write down their numbers and divide them into experimental and control groups)
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shahid Beheshti University
Street address
Unit 1 , East First Floor , NO 32,Moosavi Alley , South Kerman Sq , Qassem Soleimani Highway
City
Tehran
Province
Tehran
Postal code
1634666416
Approval date
2022-03-12, 1400/12/21
Ethics committee reference number
IR.SBU.REC.1400.267

Health conditions studied

1

Description of health condition studied
Stress Urinary Incontinence (SUI)
ICD-10 code
N39.3
ICD-10 code description
Stress incontinence (female) (male)

Primary outcomes

1

Description
Urinary Incontinence
Timepoint
Before eight weeks of yoga and after eight weeks of yoga.
Method of measurement
Incontinence Questionnaire–Urinary Incontinence Short Form (ICIQ-UI SF)

Secondary outcomes

1

Description
Urinary Incontinence Quality Of Life
Timepoint
Before and after eight weeks of yoga.
Method of measurement
Incontinence Quality Of Life(IQOL)

2

Description
Bladder neck descent
Timepoint
Before and after eight weeks of yoga
Method of measurement
Ultrasound

3

Description
The diameter of the urogenital hiatus
Timepoint
Before and after eight weeks of yoga
Method of measurement
Ultrasound

4

Description
Pelvic floor muscle strength
Timepoint
Before and after eight weeks of yoga
Method of measurement
Vaginal touch clinical test

5

Description
Angles of rotation of the urethra
Timepoint
Before and after eight weeks of yoga
Method of measurement
Ultrasound

Intervention groups

1

Description
Intervention: Yoga exercises group. After checking the records and evaluation using the form to collect information such as age, sports history, pregnancy history, disease history and drug use, etc and the international form of urinary incontinence from the patients,10 people will be selected with stress urinary incontinence. Then these people will be invited by signing the consent form. until the pre-test (quality of life questionnaire, two-dimensional ultrasound of pelvic floor muscles and clinical assessment of vaginal touch) and after the implementation of yoga rehabilitation exercise program to strengthen pelvic floor muscles and core muscles and breathing exercises for eight weeks in three sessions An hour and a quarter per week and in each session, a post-test (quality of life questionnaire, two-dimensional ultrasound of the pelvic floor muscles and clinical assessment of vaginal palpation) is performed.
Category
Rehabilitation

2

Description
Intervention: Yoga exercises group. After checking the records and evaluation using the form to collect information such as age, sports history, pregnancy history, disease history and drug use, etc and the international form of urinary incontinence from the patients,10 people will be selected with stress urinary incontinence. Then these people will be invited by signing the consent form. until the pre-test (quality of life questionnaire, two-dimensional ultrasound of pelvic floor muscles and clinical assessment of vaginal touch) and in these four weeks he continued with his routine activities and finally a post-test (quality of life questionnaire, two-dimensional ultrasound of the pelvic floor muscles and clinical assessment of vaginal palpation) is performed.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Sport Clubs
Full name of responsible person
Maryam Shirzad
Street address
Unit 1 , East First Floor , NO 32,Moosavi Alley , South Kerman Sq , Qassem Soleimani Highway
City
Tehran
Province
Tehran
Postal code
1634666416
Phone
+98 21 2250 0149
Email
maryam90_sh@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshar Jafari
Street address
School of Sport and Health Sciences, Shahid Beheshti Univercity, Shahid Dr , Shahriari Square (Univercity Square), Rashiduddin Fazlulla St.,Yaman St., Velenjak,Chamran Highway,Tehran
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 58 2429 9021
Email
Af_jafari@sbu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Other

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fariborz Hovanlo
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physical Education
Street address
School of Sport and Health Sciences, Shahid Beheshti Univercity, Shahid Dr , Shahriari Square (Univercity Square), Rashiduddin Fazlulla St.,Yaman St., Velenjak,Chamran Highway,Tehran
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2990 5821
Email
f_hovanloo@sbu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fariborz Hovanlo
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physical Education
Street address
School of Sport and Health Sciences, Shahid Beheshti Univercity, Shahid Dr , Shahriari Square (Univercity Square), Rashiduddin Fazlulla St.,Yaman St., Velenjak,Chamran Highway,Tehran
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2990 5821
Email
f_hovanloo@sbu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fariborz Hovanlo
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physical Education
Street address
School of Sport and Health Sciences, Shahid Beheshti Univercity, Shahid Dr , Shahriari Square (Univercity Square), Rashiduddin Fazlulla St.,Yaman St., Velenjak,Chamran Highway,Tehran
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2990 5821
Email
f_hovanloo@sbu.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
The information about the subjects is personal and will not be shared with others.
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
No - There is not a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All information expcept the personal information.
When the data will become available and for how long
Six months after the results are published.
To whom data/document is available
All researchers
Under which criteria data/document could be used
The use of research result is unimpeded by acquiring the source
From where data/document is obtainable
maryam90_sh@yahoo.com
What processes are involved for a request to access data/document
At least two working days.
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