Protocol summary
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Study aim
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Comparison of the effectiveness of Kegel exercises and Paula method on the severity of stress urinary incontinence in elderly women
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Design
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The clinical trial have a control group, with parallel groups, without blinding, randomized, on 114 patients. www.randomizer.org site was used for randomization
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Settings and conduct
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Participants are elderly women complaining of stress urinary incontinence referred to health centers. They will be selected based on inclusion and exclusion criteria. They will be followed in the first, third, ninth and thirteenth weeks. They will be evaluated by ICIQ-UI SF questionnaire, pad weighting, and ultrasonography before and after the intervention.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Women over 60-year-old; moderate to severe score of stress urinary incontinence based on the ICIQ-UI SF questionnaire; Leakage of urine at least one gram over an hour with pad test; MMSE score above 12
Exclusion criteria: Treatment with other similar exercises in a recent year; Taking medications that have side effects that affect bladder function; History of previous surgery for urinary incontinence; History of pelvic radiotherapy during the last 5 years; Uterine prolapse or cystocele grade 3 or higher; History of pelvic surgery; Heart or respiratory disease or movement disorders; Hysterectomy; Neurological diseases such as multiple sclerosis, Parkinson's, brain tumor, Stroke or spinal cord injury; urinary tract or urinary stones; Chronic constipation
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Intervention groups
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Intervention Group 1: Paula method; Strengthen the pelvic floor muscles by contracting and expanding the circular muscles in other parts of the body.
Intervention Group 2: Kegel exercises; Strengthen the pelvic floor muscles by Contraction and expansion them.
Control Group: Routine Measures
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Main outcome variables
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ICIQUI-SF Score; Pad Weight; Bladder neck descent; The amount of VLPP
General information
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Reason for update
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Due to the corona virus epidemic and personal problems of the researcher, the sampling process started with a delay
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20210219050410N1
Registration date:
2021-07-20, 1400/04/29
Registration timing:
prospective
Last update:
2023-10-22, 1402/07/30
Update count:
2
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Registration date
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2021-07-20, 1400/04/29
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2023-04-04, 1402/01/15
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Expected recruitment end date
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2023-11-25, 1402/09/04
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparing the Effectiveness of Kegel Exercises and Paula Method on the Severity of Stress Urinary Incontinence in Aged Women in Virtual Training: A Parallel Randomized Clinical Trial
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Public title
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Comparing the Effectiveness of Kegel Exercises and Paula Method on the Severity of Stress Urinary Incontinence in Aged Women in Virtual Training: A Parallel Randomized Clinical Trial
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
All 60-year-old and above female cases referred to health centers
Women with moderate to severe stress urinary incontinence based on ICIQ-UISF questionnaire
Women with MMSE scores above 12 for cognitive abilities
Women with urine leakage at least one gram/hour in the pad test
Exclusion criteria:
Women treated with other similar exercises over the last year
Women under medications with side-effect on bladder function
Women diagnosed cases of oregonomegaly
Women with a previous history of surgery for urinary incontinence
Women with a history of pelvic radiation therapy during the last 5 years
Women with uterine prolapse or cyctocel, grade 3 or above
Women with a history of pelvic surgery
Women with cardiac, respiratory or motor disorders
Women with a history of hysterectomy
Women with urinary tract infections or urinary stones
Women with chronic constipation
Women with some neurological diseases such as multiple sclerosis, Parkinson's, brain tumor, stroke, and spinal cord injury
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Age
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From 60 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
114
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Patients will be divided into three groups (two in intervention groups and one in control group) through randomization and based on the production of random numbers strings through software. (www.randomizer.org)
In order for the number of assignments to each group to be equal, the block method of volume 6 is used to create a random allocation sequence because participants are gradually entered into the study.
The allocation concealment will be done centrally. In this way, the assignment sequence will be done by someone outside the research team. Upon each person entering the study, the researcher will contact the person and assign the person to the group.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Training instructions and follow-ups will be implemented virtually.
Ethics committees
1
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Ethics committee
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Approval date
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2021-06-21, 1400/03/31
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Ethics committee reference number
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IR.SHMU.REC.1400.074
Health conditions studied
1
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Description of health condition studied
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Stress urinary incontinence
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ICD-10 code
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N39.3
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ICD-10 code description
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Stress incontinence (female)
Primary outcomes
1
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Description
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The amount of Bladder neck descent
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Timepoint
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Before the intervention and one week after the intervention in the Kegel group (ninth week) and one week after the intervention in the Paula and control groups (13th week)
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Method of measurement
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Sonography
2
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Description
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The amount of pressure in which urine leakage occurs. (VLPP)
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Timepoint
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Before the intervention and one week after the intervention in the Kegel group (ninth week) and one week after the intervention in the Paula and control groups (13th week)
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Method of measurement
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Sonography
Secondary outcomes
1
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Description
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Pad weight
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Timepoint
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Before the intervention and one week after the intervention in the Kegel group (ninth week) and one week after the intervention in the Paula and control groups (13th week)
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Method of measurement
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Notebook Digital scale machine
2
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Description
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Stress urinary incontinence score in ICIQ-UI SF questionnaire
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Timepoint
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Before the intervention and one week after the intervention in the Kegel group (ninth week) and one week after the intervention in the Paula and control groups (13th week)
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Method of measurement
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ICIQ-UI SF Questionnaire
Intervention groups
1
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Description
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Intervention group: Paula method, which includes a group of circular muscle exercises to return proper functioning of the body, allows to strengthen the pelvic floor muscles by contracting and expanding the circular muscles in other parts of the body such as the eyes, lips, hands and nose. Paula method will be taught to the elderly people via CD and a link to download educational videos and brochures, and the elderly people will be asked to do this method for 12 weeks and every week for 45 minutes. People are encouraged to perform this method daily for 15-45 minutes. Treatment companions can also contact the person in charge of the investigation in case of any questions or problems
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Category
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Rehabilitation
2
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Description
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Intervention group: Kegel exercises is the contraction and expansion of the pelvic floor muscles and leads to strengthening of the pelvic floor muscles. These exercises last for 8 weeks and 10 sets a day. Each time involves 10-12 seconds of contraction and 10-12 seconds of rest
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Category
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Rehabilitation
3
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Description
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Control group will receive the routine intervention in treatment centers
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Category
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N/A
1
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Sponsor
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Grant name
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Research
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Grant code / Reference number
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924
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shahroud University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Some of the patients' demographic information can be shared after unidentifying individuals. All the results of the pad test, ultrasound and urinary incontinence questionnaire can be shared with caregivers after unidentified individuals.
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When the data will become available and for how long
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After publishing the article
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To whom data/document is available
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Project partners
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Under which criteria data/document could be used
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People who do similar research
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From where data/document is obtainable
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It will be done by email with the person in charge of the project
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What processes are involved for a request to access data/document
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The data will be available to individuals via email
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Comments
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