Evaluation of the effect of radiofrequency in the repair of pelvic floor disorders in postpartum women
Design
This is a pre-and post-interventional study performed on 50 postpartum women.
Settings and conduct
In this interventional study, 50 postpartum women in Yas and Imam Khomeini hospitals are selected by convenience sampling.
Participants/Inclusion and exclusion criteria
Inclusion criteria include age 18 to 40 years, postpartum women (with at least 6 weeks after their vaginal delivery), by diagnosing pelvic floor dysfunction based on the women's history and clinical examination. Criteria for not entering: women with metal implants such as intrauterine device (IUD), women with active infection, vaginal unhealed tears, smoker and withdrawal to participate.
Intervention groups
For all participants, radiofrequency therapy is performed using a Votiva bipolar RF device implanted in the vagina. The Urogynecology Fellowship determines the number of treatment sessions. Also, pelvic floor muscle tone at rest and at maximal pelvic muscle contractions is measured by a musculoskeletal simulator 3 times (before the first and second sessions of RF treatment and two weeks after) for each patient regardless of the number of RF sessions.
Main outcome variables
Rest pelvic floor muscle tone and maximal pelvic muscle contractions
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220620055225N1
Registration date:2022-06-22, 1401/04/01
Registration timing:prospective
Last update:2022-06-22, 1401/04/01
Update count:0
Registration date
2022-06-22, 1401/04/01
Registrant information
Name
Khadijeh Adabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8894 8217
Email address
kh_adabi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-23, 1401/05/01
Expected recruitment end date
2023-07-23, 1402/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of radiofrequency in the repair of pelvic floor disorders in postpartum women
Public title
The effect of radiofrequency in the repair of pelvic floor disorders in postpartum women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Aged 18 to 40 years
Postpartum women (with at least 6 weeks after their vaginal delivery)
By diagnosing pelvic floor dysfunction based on the women's history and clinical examination
Exclusion criteria:
Women with metal implants such as intrauterine device (IUD)
Women with active infection
Vaginal unhealed tears
Smoker
Withdrawal to participate
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Imam Khomeini Hospital Complex- Tehran University of Medical Sciences
Street address
Research Ethics Committees of Imam Khomeini Hospital Complex, Dr. Gharib Street, Keshavarz Boulevard.
City
Tehran
Province
Tehran
Postal code
1419733141
Approval date
2022-02-27, 1400/12/08
Ethics committee reference number
IR.TUMS.IKHC.REC.1400.476
Health conditions studied
1
Description of health condition studied
Postpartum care
ICD-10 code
Z39
ICD-10 code description
Encounter for maternal postpartum care and examination
Primary outcomes
1
Description
Rest pelvic floor muscle tone
Timepoint
3 times, before the first and second sessions of RF treatment and two weeks after
Method of measurement
Musculoskeletal simulator
2
Description
Maximal pelvic muscle contractions
Timepoint
3 times, before the first and second sessions of RF treatment and two weeks after
Method of measurement
Musculoskeletal simulator
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For all participants, radiofrequency therapy is performed using a Votiva bipolar RF device implanted in the vagina. The Urogynecology Fellowship determines the number of treatment sessions. Also, pelvic floor muscle tone at rest and at maximal pelvic muscle contractions is measured by a musculoskeletal simulator 3 times (before the first and second sessions of RF treatment and two weeks after) for each patient regardless of the number of RF sessions.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Yas hospital
Full name of responsible person
Khadijeh Adabi
Street address
Yas hospital, Next to the sarv street , North Nejatollahi street , karim khan ave
City
Tehran
Province
Tehran
Postal code
1597856511
Phone
+98 21 8608 9089
Email
kh_adabi@sina.tums.ac.ir
2
Recruitment center
Name of recruitment center
Imam Khomeini Hospital Complex
Full name of responsible person
Khadijeh Adabi
Street address
Imam Khomeini Hospital Complex, Dr. Gharib Street, Keshavarz Boulevard.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2047
Email
kh_adabi@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Vice-Dean of Research of Tehran University of Medical Sciences, Dr. Fotouhi
Street address
Vice-Dean of Research, Tehran University of Medical Sciences, Floor 6, Qods St., Keshavarz Blvd, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1416634793
Phone
+98 21 6381 9836
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Khadijeh Adabi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Karim Khan Blvd., North Nejat Elahi St., Yas Hospital
City
Tehran
Province
Tehran
Postal code
1598718311
Phone
+98 21 8894 8217
Fax
Email
kh_adabi@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Khadijeh Adabi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Karim Khan Blvd., North Nejat Elahi St., Yas Hospital
City
Tehran
Province
Tehran
Postal code
1598718311
Phone
+98 21 8894 8217
Fax
Email
kh_adabi@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Khadijeh Adabi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Karim Khan Blvd., North Nejat Elahi St., Yas Hospital
City
Tehran
Province
Tehran
Postal code
1598718311
Phone
+98 21 8894 8217
Fax
Email
kh_adabi@sina.tums.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
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
All data is potentially shareable after unidentified participants.
When the data will become available and for how long
After the manuscript is published.
To whom data/document is available
No limitations.
Under which criteria data/document could be used
The data is only available to the project manager, Dr. Khadijeh Adabi, and any analysis must be done with her opinion.
From where data/document is obtainable
Dr. Khadijeh Adabi
What processes are involved for a request to access data/document
Any request must be sent by e-mail with its proposal to Dr. Khadijeh Adabi.