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IRCT20210928052626N1 IRCT 2022-11-27 Esfahan University of Medical Sciences Evaluation of the efficacy of using the pelvic floor muscle training application in comparison with physiotherapy Evaluation of the efficacy of using the pelvic floor muscle training application in comparison with physiotherapy in patients with urinary incontinence 2022-10-23 anticipated 70 Complete https://irct.ir/trial/66391 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: first the participants are grouped by degree of urinary incontinence in three groups, then the patient's names are sorted by the alphabetic order, and each of them assigned a number. Patients are randomly assigned to control and intervention groups by random allocation software in individual units. Block randomization will be used with a block size of 6, Blinding description: n this study, the patients and the clinical caregiver providing physiotherapy services and the person who teaches the use of the app are aware of which group they belong to. However, the researcher and the analyst do not know about the division of the patients. N/A stress or mixed urinary incontinence. Intervention 1: intervention group: our designed application is used to train the intervention group with kegel exercises for three months and 30 minutes each day. Intervention 2: Control group: these patients are prescribed 10-15 physiotherapy sessions for pelvic floor muscle training. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is I will decide after finishing the study
public Maede Safari
Hazar Jarib St., Isfahan University of Medical Sciences and Health Services
Isfahan Iran (Islamic Republic of) 73461-81746 +98 31 3668 0048 safari.maede@yahoo.com Esfahan University of Medical Sciences scientific Maede Safari
No. 46, Shadab Alley, West Sharif Avenue, Ghadir Blvd., Kharazmi 3, Sepahanshahr
Isfahan Iran (Islamic Republic of) 8179975514 +98 31 3650 7377 safari.maede@yahoo.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Age : 18-70 y/o Female Urinary incontinence for at least once a week Diagnosed stress or mixed incontinence Vaginal prolapse grade 1 or 2 BMI=20-30 18 years 70 years Female Difficulty urinating Pregnancy Macroscopic hematuria Urinary symptoms related to grade 3 or 4 of POP N39.3 Stress incontinence (female) (male) Rehabilitation Rehabilitation intervention group: our designed application is used to train the intervention group with kegel exercises for three months and 30 minutes each day. Control group: these patients are prescribed 10-15 physiotherapy sessions for pelvic floor muscle training The score obtained in the International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life. Timepoint: The beginning of the study (before the start of the intervention) and three months after its start. Method of measurement: The ICIQ-LUTS-qol questionnaire. The score obtained in the International Consultation on Incontinence Questionnaire - Short Form. Timepoint: The beginning of the study (before the start of the intervention) and three months after its start. Method of measurement: International Consultation on Incontinence Questionnaire - Short Form questionnaire. Esfahan University of Medical Sciences Approved 2022-10-19 Ethics committee of Isfahan University of Medical sciences Kharazmi 3 avenue, Sepahanshahr Isfahan Isfehan Iran (Islamic Republic of)