Protocol summary
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Study aim
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Determining the effect of Kegel exercise on Urinary Incontinence, Frailty Index, and Self-esteem in the elderly after Prostatectomy
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Design
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The study has a control group and an intervention group, each group of 38 people and a total of 76 patients will be present in the study.
Balance-block randomization with 4 permutations will be used for random allocation. Blocks used include: 1.CCII, 2. CICI, 3. CIIC, 4. IICC, 5. ICIC and 6. ICCI in which the letter I(Intervention) and the letter C (control) will be. RAS (Research Analysis and Statistics) software was used to generate random blocks.
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Settings and conduct
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The study site is the patient's place of residence. The study method will include 60 Kegel exercises daily for 12 weeks. But no softening will be done for the control group.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Transurethral Resection of Prostate (TURP), no history of other pelvic surgeries, no diagnosis of prostate cancer after surgery according to biopsy and pathology results, living in Ilam province, obtaining a score of 24 and above in MMSE, a score of 4 and above In the Urinary Incontinence Diagnosis Questionnaire, a score higher than 5 in the Edmonton Frailty Scale Questionnaire
Exclusion criteria: Any hospitalization after the intervention, Urinary Tract Infection immediately after surgery, use of drugs to control urinary incontinence, candidate for chemotherapy after surgery due to diagnosis of other types of cancer
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Intervention groups
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The intervention group will perform 60 Kegel exercises daily for 12 weeks after surgery. The control group will not perform any exercises.
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Main outcome variables
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Decreased Urinary Incontinence; Increase Self-esteem; decreased frailty; positive effect of increased Self-esteem on decrease frailty
General information
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Reason for update
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Change of writing in the title of the article for printing
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20211110053030N1
Registration date:
2021-12-27, 1400/10/06
Registration timing:
registered_while_recruiting
Last update:
2022-11-05, 1401/08/14
Update count:
1
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Registration date
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2021-12-27, 1400/10/06
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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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2021-12-11, 1400/09/20
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Expected recruitment end date
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2022-03-11, 1400/12/20
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Actual recruitment start date
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2021-12-22, 1400/10/01
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Actual recruitment end date
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2022-03-01, 1400/12/10
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Trial completion date
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2022-06-22, 1401/04/01
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Scientific title
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Effects of Kegel exercise effect on urinary incontinence, frailty index and self-esteem in elderly men after Transurethral Resection of Prostate (TURP) in Ilam county in 2021 (a randomized, single-blinded, controlled clinical trial)
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Public title
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Kegel exercise effect on incontinence, Frailty index, and Self-esteem in elderly men after Prostatectomy
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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Inclusion criteria:
Transurethral Resection of Prostate (TURP) in at least one day and at most 3 days
Age 65 years and older
Lack of other history of pelvic surgery
Failure to diagnose prostate cancer after surgery based on biopsy and pathology
Willingness to participate in research and to have Informed Consent
Primary and higher literacy rates
Achieving a score of 24 and above in the Mini-Mental State Examination (MMSE) to determine whether he is teachable and has no dementia
Score 4 or higher on the Urinary Incontinence Diagnosis Questionnaire (QUID)
Score higher than 5 on the Edmonton Frailty Scale (EFS)
Exclusion criteria:
Having a urinary tract infection immediately after surgery
Having a heart attack and stroke after entering the intervention
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Age
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From 65 years old
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Gender
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Male
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
76
Actual sample size reached:
76
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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After entering the research based on the inclusion criteria, Balance-block randomization with 4 permutations will be used to assign individuals to control and intervention groups as random allocation 1.CCII, 2. CICI, 3. CIIC, 4. IICC, 5. ICIC and 6. ICCI were in which the letter C (control) and the letter I (intervention). RAS (Research Analysis and Statistics) software will be used to generate random blocks, and a random number table will be used to select each block. Envelopes will be embedded to hide the created sequence, which will be exactly the same. They are written random codes and each code will represent a type of a block that will contain 4 letters (P or G). The list of codes prepared for each envelope will be determined by the research team and the final list will be at the discretion of the lead researcher. This method will ensure that the doctor or nurse prescribing the training does not know the type of intervention.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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We blind interviewers the have rule for data gathering form participants as he/she just access of codes prepared for each envelope (randomization step) and no other information may lead to leak of random sequences.
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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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Ethics committees
1
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Ethics committee
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Approval date
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2021-12-06, 1400/09/15
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Ethics committee reference number
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IR.MEDILAM.REC.1400.167
Health conditions studied
1
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Description of health condition studied
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Urinary Incontinence
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ICD-10 code
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N39.4
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ICD-10 code description
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Other specified urinary incontinence
2
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Description of health condition studied
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Frailty Index
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ICD-10 code
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ICD-10 code description
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3
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Description of health condition studied
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Self esteem
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Urinary incontinence
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Timepoint
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Before enrollment, 8 weeks after enrollment, one month after enrollment
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Method of measurement
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Abridged Form of the International Urinary Incontinence Counseling Questionnaire (ICIQ)
2
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Description
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Frailty Index
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Timepoint
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Before enrollment, 8 weeks after enrollment, one month after enrollment
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Method of measurement
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Edmonton Frailty scale(EFS)
3
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Description
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Self-esteem
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Timepoint
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Before enrollment, 8 weeks after enrollment, one month after enrollment
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Method of measurement
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Rosenberg Self-Esteem Scale (RSES)
Intervention groups
1
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Description
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Intervention group: Kegel exercise includes a series of contractions that target the pelvic floor muscles (bladder muscles, valvular muscles, pelvic muscles). After being eligible for the study, the people in the intervention group will be asked how to do the Kegel exercise. First, to identify the location of the pelvic floor muscles, we explain to the person that when you are urinating, try to cut off and connect your urine flow. It is the pelvic floor muscles that cut and connect the flow of your urine. Do this for two or three times to find out the exact location and work of these muscles. Then, after the patient identifies his pelvic floor muscles, we ask him to contract these muscles for five seconds (count from one thousand and one to one thousand and five) and relax these muscles after counting. This move is a Kegel sport. The intervention group will perform sixty of these contractions daily three times a day (20 in the morning, 20 at noon, and 20 at bedtime) for 12 weeks. In the eighth week of the intervention group, the questionnaires on fragility, self-esteem, and urinary incontinence will be completed again. Then, one month after the end of the Kegel exercise, in the twelfth week of the presence of individuals in the intervention group, the three mentioned questionnaires will be completed again and the data will be entered into SPSS V.21 software for analysis. The intervention group will receive a pamphlet introducing the pelvic floor muscles and how the Kegel exercise was performed by the research team using credible sources, as well as a checklist in which the Kegel exercise is expected to be counted and counted. Placed, will receive. In addition, the members of the intervention group will have the contact number of the researcher to contact him in case of questions or need guidance. The researcher will also be in contact with the members of the intervention group on a weekly basis to check the manner and number of Kegel exercises performed to check the eligibility of individuals to participate in the continuation of the study.In addition, the informed consent form will be obtained from individuals at the beginning of the research.
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Category
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Treatment - Other
2
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Description
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Control group: The subjects in the control group did not do any kegel exercises after entering the study, and the subjects in this group after the eighth week and one month after the twelfth week of the study, fragility questionnaires, self-esteem, and urinary incontinence were complete the option and the data will be entered into SPSS V.21 software for analysis. Of course, in order not to be deprived of the benefits of research, the pamphlet will receive how to do Kegel exercise, with the difference that in this pamphlet, the number of Kegel exercises to do, the reason for doing Kegel exercise is not written. In addition, people in the control group will have the contact number of the researcher to contact him in case of questions or need guidance. The researcher will also check the absence of Kegel exercise and the control group's awareness of the existence of such exercise by being in contact with the control group on a weekly basis to check the eligibility of individuals to participate in the continuation of the research.In addition, the informed consent form will be obtained from individuals at the beginning of the research.
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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No - possible costs are paid by the student himself.
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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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Private
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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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Persons
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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No - There is not 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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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available
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Title and more details about the data/document
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All potential data can be shared after identifying individuals.
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When the data will become available and for how long
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Access period starts 6 months after the results are published
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To whom data/document is available
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Doctors, nurses, surgeons, and staff of health centers
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Under which criteria data/document could be used
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Prerequisites for submitting an application include use for referral for reference, faculty or student being a researcher or working in a hospital or surgical clinic.
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From where data/document is obtainable
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The responsible author can be contacted at the email address: mozafaric@yahoo.com and the student's email address: rezawest10@gmail.com
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What processes are involved for a request to access data/document
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After completing the study and publishing the results, by sending an email to the responsible author, he can access the documents for a maximum of 6 weeks.
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Comments
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