Investigation of the effect of radiofrequency on improvement of vaginalaxity and loss of sexuality in women referring to Mashhad educational hospital clinics
Determining the effect of radiofrequency on improving vaginal laxity and reduced sexual desire in women referring to the Mashhad educational hospital clinics
Design
Clinical trial with no control or parallel groups, not blinded and not randomized, and conducted on 30 patients
Settings and conduct
This study will be performed on 30 women referring to the hospital clinic with complaints of vaginal laxity. A gynecology resident performs vaginal examination on patients and based on inclusion criteria, patients enter the study. The treatment is ambulatory and is conducted in a clinic. Patients are treated with a radiofrequency device in three sessions and each session lasts 30 minutes.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age between 25-50 years; having complaints of vaginal laxity; not having breastfed within the the three months before the study; sexual activity; normal Pap test result; negative pregnancy test before entering the study. Exclusion criteria: pelvic organ prolapse has exceeded the hymenal ring; active sexually transmitted disease; chronic vulvar pain or vulvar dystrophy; using known medications that affect sexual function; daily use of anti-inflammatory drugs which can affect collagen in healing; chronic skin disorder including vulvar involvement; medical problem that interferes with wound healing; thin rectovaginal septum; being under treatment for hypoactive sexual dysfunction (HSDD) or orgasmic disorder; detected IBS
Intervention groups
Patients are treated with a radiofrequency device in three sessions and each session lasts 30 minutes within 1 to 3 months. This thermotherapy device uses radiofrequency technology to treat vaginal laxity and rejuvenate the external genitalia in women.
Main outcome variables
Sexual function, vaginal laxity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201006048949N1
Registration date:2021-08-10, 1400/05/19
Registration timing:registered_while_recruiting
Last update:2021-08-10, 1400/05/19
Update count:0
Registration date
2021-08-10, 1400/05/19
Registrant information
Name
Azimeh Golzar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3727 9757
Email address
golzarta961@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-28, 1400/05/06
Expected recruitment end date
2022-02-25, 1400/12/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the effect of radiofrequency on improvement of vaginalaxity and loss of sexuality in women referring to Mashhad educational hospital clinics
Public title
The effect of radiofrequency on improvement of vaginalaxity and loss of sexuality in women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 25-50 years
Having complaints of vaginal laxity
Not having breastfed within the the three months before the study
Sexual activity (vaginal sex at least once a month)
Normal Pap test result
Negative pregnancy test before entering the study
Exclusion criteria:
Pelvic organ prolapse has exceeded the hymenal ring (grade 3 and 4 prolapse)
Active sexually transmitted disease (Condylomata acuminata / herpes)
Chronic vulvar pain or vulvar dystrophy
Using known medications that affect sexual function (antihypertensive and psychotropic drugs / chemotherapeutic agents)
Daily use of anti-inflammatory drugs which can affect collagen in healing (ibuprofen / aspirin / steroids)
Chronic skin disorder including vulvar involvement
Medical problem that interferes with wound healing.
Thin rectovaginal septum
Under treatment for Hypoactive Sexual Desire Disorder (HSDD) or orgasmic disorder
Irritable bowel syndrome (IBS)
Age
From 25 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
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
Ethics Committee of Mashhad University of Medical Sciences
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Approval date
2020-09-26, 1399/07/05
Ethics committee reference number
IR.MUMS.REC.1399.458
Health conditions studied
1
Description of health condition studied
Vaginalaxity
ICD-10 code
N81
ICD-10 code description
Female genital prolapse
Primary outcomes
1
Description
Sexual function
Timepoint
Before the intervention, at months 1, 2, 3 during the study before each treatment session, and 3and 6 months after the intervention
Method of measurement
Female Sexual Function Index
2
Description
Vaginal laxity
Timepoint
Before the intervention, at months 1, 2, 3 during the study before each treatment session, and 3and 6 months after the intervention
Method of measurement
Vaginal Laxity Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group, treatment was ambulatory and was done in a clinic. Patients are treated with a radiofrequency device in three sessions and each session lasts 30 minutes within 1 to 3 months. This thermotherapy device uses radiofrequency technology to treat vaginal laxity and rejuvenate the external genitalia in women. This device can work with four different frequencies (420,500,720,1000), which allows changing the depth of penetration of the waves according to the type of patient's problem and the type of treatment needed.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Mashhad educational hospital clinics
Full name of responsible person
Nafiseh Saghafi
Street address
Ahmadabad St., Ghaem Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3841 7493
Email
saghafiN@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
91388-13944
Phone
+98 51 3841 2081
Email
ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Azimeh Golzar
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
NO. 31, Haft Tir 3 St., Vakilabad Blvd.,
City
Mashhad
Province
Razavi Khorasan
Postal code
9178864689
Phone
+98 51 3727 9757
Email
golzarta961@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Nafiseh Saghafi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Ahmadabad Blvd., Ghaem Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3841 7493
Email
SaghafiN@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Saghafi Nafiseh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Ghaem Hospital, Ahmadabad Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3841 7493
Email
SaghafiN@mums.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 patients are made unidentifiable.
When the data will become available and for how long
Data can be accessible 6 months after results are published.
To whom data/document is available
Data can be accessible through an email to the corresponding author.
Under which criteria data/document could be used
Data will be available for researchers in universities and other scientific institutes.
From where data/document is obtainable
After sending a request email to the corresponding author, data will be sent in 1 month.
What processes are involved for a request to access data/document