Investigating the effectiveness of High Intensive Focused Ultrasound (HIFO) in the treatment of urinary and fecal symptoms caused by rectocele and cystocele
Determining the effectiveness of High Intensive Focused Ultrasound (HIFO) in the treatment of pain caused by rectocele and cystocele
Design
A clinical trial with a control group with parallel groups, no-blinded, randomized on 100 patients and randomization via random number table.
Settings and conduct
The study was conducted in 1401 in Isfahan city. People are randomly placed in one of the two groups of Kegel and Haifu exercises, and the patients' symptoms and their condition are evaluated in two and six months. Kegel exercises are explained orally to the patients and they will practice 3 times a day for six months. 4.5 mm cartridge is also used for Hifo. For shots, 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 between each line and less than 1 mm between each shot. The frequency of the device for the 4.5 mm cartridge is 4 MHz.
Participants/Inclusion and exclusion criteria
The inclusion criteria are women aged between 18 and 60 who have symptomatic grade 1 and 2 rectocele and cystocele.
Exclusion criteria are people who do not consent to participate in the study
Intervention groups
HIFU and Kegel
Main outcome variables
pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160521027998N10
Registration date:2023-04-17, 1402/01/28
Registration timing:prospective
Last update:2023-04-17, 1402/01/28
Update count:0
Registration date
2023-04-17, 1402/01/28
Registrant information
Name
Maryam Hajihashemi
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3776 6578
Email address
m_hajihashemy@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-21, 1402/02/01
Expected recruitment end date
2023-06-22, 1402/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effectiveness of High Intensive Focused Ultrasound (HIFO) in the treatment of urinary and fecal symptoms caused by rectocele and cystocele
Public title
Hifo effect in rectocele and cystocele
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
grade 1 and 2 rectocele and cystocele
Exclusion criteria:
lack of consent
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics comittee of isgahan university of medical science
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
7346181746
Approval date
2022-08-23, 1401/06/01
Ethics committee reference number
IR.MUI.MED.REC.1401.211
Health conditions studied
1
Description of health condition studied
Rectocele and Cyctocele
ICD-10 code
N81.1
ICD-10 code description
Cystocele
2
Description of health condition studied
Rectocele
ICD-10 code
N81.6
ICD-10 code description
Rectocele
Primary outcomes
1
Description
pain
Timepoint
2 week.2 month, 6 month
Method of measurement
visual analogue scale (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Treatment - Devices
2
Description
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.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati hospital
Full name of responsible person
Maryam Hajheshemy
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3668 0048
Email
m_hajihashemy@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr.Amir Rahimi
Street address
Hezar Jarib street,
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3668 0048
Email
m_hajihashemy@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Maryam Hajihashemi
Position
associated professor
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Hezar Jarib St., Isfahan
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3776 6578
Fax
+98 31 3236 4210
Email
m_hajihashemy@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Maryam Hajihashemi
Position
Associated professor
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Hezar Jarib St., Isfahan
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3776 6578
Fax
+98 31 3236 4210
Email
m_hajihashemy@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Maryam Hajihashemi
Position
Associated professor
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Hezar Jarib St., Isfahan
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3776 6578
Fax
+98 31 3236 4210
Email
m_hajihashemy@med.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be shared after de-identification
When the data will become available and for how long
1402
To whom data/document is available
academic institutes
Under which criteria data/document could be used
academic researches
From where data/document is obtainable
dr. Maryam hajhashemi. 09132137267
What processes are involved for a request to access data/document