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IRCT20160521027998N10 IRCT 2023-04-17 Esfahan University of Medical Sciences Hifo effect in rectocele and cystocele Investigating the effectiveness of High Intensive Focused Ultrasound (HIFO) in the treatment of urinary and fecal symptoms caused by rectocele and cystocele 2023-04-21 anticipated 100 Complete https://irct.ir/trial/65792 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization was done with the help of a random number table, in the order in which people entered the study, with the help of a random number table, they were assigned a number. N/A Condition 1: Rectocele and Cyctocele. Condition 2: Rectocele. Intervention 1: Intervention group: HIFU. In the treatment in this study, HIFU device is used using a 4.5 mm cartridge that penetrates to the fascia and can strengthen the pelvic muscles, and the energy produced is 1.5 joules. To shoot, the area from the end of the vagina to the front is divided into 3 parts, and shots are taken at intervals of 2.5 cm and less than 1 mm between each shot in each line. The frequency of the device for the 4.5 mm cartridge is 4 MHz. Two weeks, two months and six months later, patients are visited. Intervention 2: Intervention group: Kegel exercises. Kegel exercises are explained orally to the patients and the patients will practice three times a day for up to 6 months. The way to follow up the exercises in the follow-up sessions will be two weeks, two months and six months later. Yes - There is a plan to make this available What will be shared: All data can be shared after de-identification When: 1402 To whom: academic institutes Conditions: academic researches Where to obtain: dr. Maryam hajhashemi. 09132137267 How to obtain: all application will be reviewed up to 1 month Comments:
public Maryam Hajihashemi
Hezar Jarib St., Isfahan
Isfahan Iran (Islamic Republic of) 7346181746 +98 31 3776 6578 m_hajihashemy@med.mui.ac.ir Isfahan University of Medical Sciences scientific Maryam Hajihashemi
Hezar Jarib St., Isfahan
Isfahan Iran (Islamic Republic of) 7346181746 +98 31 3776 6578 m_hajihashemy@med.mui.ac.ir Isfahan University of Medical Sciences Iran (Islamic Republic of) grade 1 and 2 rectocele and cystocele no limit no limit Female lack of consent N81.1 N81.6 Cystocele Rectocele Treatment - Devices Rehabilitation Intervention group: HIFU. In the treatment in this study, HIFU device is used using a 4.5 mm cartridge that penetrates to the fascia and can strengthen the pelvic muscles, and the energy produced is 1.5 joules. To shoot, the area from the end of the vagina to the front is divided into 3 parts, and shots are taken at intervals of 2.5 cm and less than 1 mm between each shot in each line. The frequency of the device for the 4.5 mm cartridge is 4 MHz. Two weeks, two months and six months later, patients are visited. Intervention group: Kegel exercises. Kegel exercises are explained orally to the patients and the patients will practice three times a day for up to 6 months. The way to follow up the exercises in the follow-up sessions will be two weeks, two months and six months later. Pain. Timepoint: 2 week.2 month, 6 month. Method of measurement: visual analogue scale (VAS). Esfahan University of Medical Sciences Approved 2022-08-23 Ethics comittee of isgahan university of medical science Hezar Jarib Isfahan Isfehan Iran (Islamic Republic of)