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IRCT20210219050410N1 IRCT 2021-07-20 Shahroud University of Medical Sciences 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 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 2023-04-04 anticipated 114 Complete https://irct.ir/trial/54439 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: Training instructions and follow-ups will be implemented virtually, Randomization description: 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. N/A Stress urinary incontinence. Intervention 1: 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. Intervention 2: 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. Intervention 3: Control group will receive the routine intervention in treatment centers. Yes - There is a plan to make this available What will be shared: 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 unidentiļ¬ed individuals. When: After publishing the article To whom: Project partners Conditions: People who do similar research Where to obtain: It will be done by email with the person in charge of the project How to obtain: The data will be available to individuals via email Comments:
public Haniyeh Ezzatmoghaddam
Haft-e Tir Sq, Shahroud University of Medical Sciences, Shahroud, Iran
Shahroud Iran (Islamic Republic of) 3614773947 +98 23 3239 5054 h.moghadam@shmu.ac.ir Shahroud University of Medical Sciences scientific Ali Dadgari
Haft-e Tir Sq, Shahroud University of Medical Sciences, Shahroud, Iran
Shahroud Iran (Islamic Republic of) 3614773947 +98 23 3239 5054 dadgari@shmu.ac.ir Shahroud University of Medical Sciences Iran (Islamic Republic of) 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 60 years no limit Female 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 N39.3 Stress incontinence (female) Rehabilitation Rehabilitation N/A 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 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 Control group will receive the routine intervention in treatment centers The amount of Bladder neck descent. Timepoint: 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). Method of measurement: Sonography. The amount of pressure in which urine leakage occurs. (VLPP). Timepoint: 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). Method of measurement: Sonography. Pad weight. Timepoint: 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). Method of measurement: Notebook Digital scale machine. Stress urinary incontinence score in ICIQ-UI SF questionnaire. Timepoint: 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). Method of measurement: ICIQ-UI SF Questionnaire. Shahroud University of Medical Sciences Approved 2021-06-21 Ethics committee of Shahroud University of Medical Sciences Haft-e Tir Sq, Shahroud University of Medical Sciences, Shahroud, Iran Shahroud Semnan Iran (Islamic Republic of)