Assessment of the impact of radiofrequency in improving symptoms in women with the pelvic floor muscle spasm
Design
This is a pre-and post-interventional study performed on 22 women with painful spasms of the pelvic floor muscle.
Settings and conduct
In this interventional study, 22 women with painful spasms of the pelvic floor muscle in Yas and Imam Khomeini hospitals are selected by convenience sampling.
Participants/Inclusion and exclusion criteria
Inclusion criteria included women aged 18 to 40 years with painful spasm of the pelvic floor muscle. Exclusion criteria: women with metal implants such as intrauterine device (IUD), women with active infection, vaginal unhealed tears, smokers, patients with pelvic floor anatomical disorders
and withdraw to participate.
Intervention groups
For all participants, radiofrequency is performed using the Dynamic Quadripolar Radiofrequency device. This device continuously produces variable and dynamic electromagnetic waves in its four electrodes, allowing the relevant diathermic effect to concentrate and penetrate the posterior pelvic tissues without requiring invasive needles. The four-ring electrodes of this device work between 1.0 and 1.3 MHz and their maximum output power are 55 watts. For all participants, at least one treatment session is done. Then according to the patient's compliance and urogynecology fellowship opinion, the total number of treatment sessions required for each patient is determined. The treatment session is planned every two weeks.
Main outcome variables
Pain and pelvic floor dysfunction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220620055225N2
Registration date:2022-07-15, 1401/04/24
Registration timing:prospective
Last update:2022-07-15, 1401/04/24
Update count:0
Registration date
2022-07-15, 1401/04/24
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
2022-08-23, 1401/06/01
Expected recruitment end date
2023-08-23, 1402/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the impact of radiofrequency in improving symptoms in women with the pelvic floor muscle spasm
Public title
The impact of radiofrequency on the pelvic floor muscle spasm
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Aged 18 to 40 years
Women with painful spasm of the pelvic floor muscle
Exclusion criteria:
Women with metal implants such as intrauterine device (IUD)
Women with active infection
Vaginal unhealed tears
Smoker
Patients with pelvic floor anatomical disorders
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:
22
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
2022-05-10, 1401/02/20
Ethics committee reference number
IR.TUMS.IKHC.REC.1401.034
Health conditions studied
1
Description of health condition studied
Painful spasm of the pelvic floor muscle
ICD-10 code
G89.4
ICD-10 code description
Chronic pain syndrome
Primary outcomes
1
Description
Pain
Timepoint
Twice, at the initiation and at the end of the study
Method of measurement
Visual analog scale
2
Description
The pelvic floor dysfunction
Timepoint
Twice, at the initiation and at the end of the study
Method of measurement
Physical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For all participants, radiofrequency is performed using the Dynamic Quadripolar Radiofrequency device. This device continuously produces variable and dynamic electromagnetic waves in its four electrodes, allowing the relevant diathermic effect to concentrate and penetrate the posterior pelvic tissues without requiring invasive needles. The four-ring electrodes of this device work between 1.0 and 1.3 MHz and their maximum output power are 55 watts. For all participants, at least one treatment session is done. Then according to the patient's compliance and urogynecology fellowship opinion, the total number of treatment sessions required for each patient is determined. The treatment session is planned every two weeks.
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 St., North Nejatollahi Str., 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
Dr. Akbar 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
Yas hospital, Next to the Sarv St., North Nejatollahi Str., Karim khan Ave.
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
Yas hospital, Next to the Sarv St., North Nejatollahi Str., Karim khan Ave.
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
Yas hospital, Next to the Sarv St., North Nejatollahi Str., Karim khan Ave.
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
The anonymous study data is potentially shareable.
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.