Dissatisfaction Appearance of the External GenitaliaPhase 2NCT02611791
Radiofrequency Female External Genital Region: a Clinical Trial
A Phase 2 study testing Radiofrequency and Radiofrequency - OFF in people with Dissatisfaction Appearance of the External Genitalia, run by Centro de Atenção ao Assoalho Pélvico.
Trial summary
OBJECTIVES: The aim of the study is to evaluate the clinical response of the non-ablative radiofrequency (RF) in the outcome cosmetic female external genital and its effect in the sexual function. METHODS: Single blind randomized controlled trial. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dissatisfaction Appearance of the External Genitalia
- What is being tested?
- Radiofrequency and Radiofrequency - OFF
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- Oct 2012to Jun 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- were included women aged between 18 and 60 years with unsatisfied the appearance of the external genital, attending the clinical physiotherapy, Bahia, Brazil
Who cannot join
- Pregnant women, women that were using copper IUD, as well as other with skin lesions in the genital region were excluded from this trial.
About this study
OBJECTIVES: The aim of the study is to evaluate the clinical response of the non-ablative radiofrequency (RF) in the outcome cosmetic female external genital and its effect in the sexual function. METHODS: Single blind randomized controlled trial. Sample of 43 women (29 sexual active) with insatisfaction appearance of the external genitalia, 21 (14) in the study group and 22 (15) in the control group. The protocol consisted in 8 sessions of RF once a week. The instruments of evaluation were photo (taken before the first session and eight days after the last session), which were evaluated by the patient and by three health professional (that did not know the group); by the 3 points Likert scale (unsatisfied, unchanged, satisfied) and (worst, unchanged, improved). The sexual function was evaluated by the Female Sexual Function Index (FSFI) before and after, and analyzed by the T Test of Student. The patients' satisfaction and the health professionals' evaluation were analyzed by the chi-squared test and by binomial comparison inter-group and intra-group.
- Being tested
- Radiofrequency, Radiofrequency - OFF
- Keywords
- Treatment by Pulsed Radio Frequency, Collagen, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiofrequencyDevice
The application of RF was through Tecatherap-VIP unit (VIP-Eletromedicina, Argentina) with bipolar method, using a gauntlet of 2cm, and the coupling electrode, which was located in the sacral region (fig x). For the application, participants were placed in a supine position with legs in lithotomy position, it was used water soluble gel for coupling and slide of the gauntlet. The application in external labia majora was made in the caudal-cranial direction, with constant movement and electrode lightly pressed. (fig) During the session, the heat level was monitored verbally and by infrared digital thermometer. The intensity was gradually increased, and at the time when the temperature reached values between 39-41ºC, the intensity was reduced two points and the procedure was maintained for two minutes.
Radiofrequency - OFFDevice
The treatment protocol for the control group was identical, differing only in relation to the RF equipment, which was turned off, but a water-soluble gel was used, heated by a resistor, preventing the patient from knowing to which group she belonged. Just the physiotherapist who performed the procedure knew which group the patient belonged to.
| Study group | Role | What they receive |
|---|---|---|
| Radiofrequency | Experimental | Eight RF sessions were performed, with an interval of seven days between them. The application of Radiofrequency in the external genitalia. Receives: Device: Radiofrequency |
| Radiofrenquency Off | Sham comparator | Eight RF sessions were performed, with an interval of seven days between them. The application of Radiofrequency in the external genital which was turned off, but a water-soluble gel was used Receives: Device: Radiofrequency - OFF |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical response
To evaluate the clinical response at radio frequencies of large labia region through the pictures before and after ( assessed by a physiotherapist , gynecologist and dermatologist ).
Measured: 2 months
Patient satisfaction
Patient satisfaction: The response to treatment will be categorized in the absence of improvement; improvement or worsening .
Measured: 2 months
Secondary outcomes (1)
Function Sexual
To evaluate the sexual response after treatment by radio frequency changes in the values of the scores(FSFI) before treatment and at the end.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2015 (estimated)
- Study startOct 2012
- Primary completionDec 2013
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dissatisfaction Appearance of the External GenitaliaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro de Atenção ao Assoalho Pélvico
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patricia V Lordelo, PhD, Principal investigator, Centro de Atenção ao Assoalho Pélvico - BAHIANA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02611791
- Sponsor's protocol ID
- U1111-1148-8313
- Status last verified
- Nov 2015
- First submitted
- 4 Nov 2015
- Last updated
- 23 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiofrequency Female External Genital Region: a Clinical Trial
- ClinicalTrials.gov ID
- NCT02611791
- Acronym / sponsor ID
- U1111-1148-8313
- Keywords
- Treatment by Pulsed Radio Frequency, Collagen, Female
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Centro de Atenção ao Assoalho PélvicoUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 23 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
OBJECTIVES: The aim of the study is to evaluate the clinical response of the non-ablative radiofrequency (RF) in the outcome cosmetic female external genital and its effect in the sexual function. METHODS: Single blind randomized controlled trial. Sample of 43 women (29 sexual active) with insatisfaction appearance of the external genitalia, 21 (14) in the study group and 22 (15) in the control group. The protocol consisted in 8 sessions of RF once a week. The instruments of evaluation were photo (taken before the first session and eight days after the last session), which were evaluated by the patient and by three health professional (that did not know the group); by the 3 points Likert scale (unsatisfied, unchanged, satisfied) and (worst, unchanged, improved). The sexual function was evaluated by the Female Sexual Function Index (FSFI) before and after, and analyzed by the T Test of Student. The patients' satisfaction and the health professionals' evaluation were analyzed by the chi-squared test and by binomial comparison inter-group and intra-group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiofrequency | Experimental | Device: RadiofrequencyEight RF sessions were performed, with an interval of seven days between them. The application of Radiofrequency in the external genitalia. |
| Radiofrenquency Off | Sham comparator | Device: Radiofrequency - OFFEight RF sessions were performed, with an interval of seven days between them. The application of Radiofrequency in the external genital which was turned off, but a water-soluble gel was used |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- were included women aged between 18 and 60 years with unsatisfied the appearance of the external genital, attending the clinical physiotherapy, Bahia, Brazil
Key exclusion criteria (1 listed)
- Pregnant women, women that were using copper IUD, as well as other with skin lesions in the genital region were excluded from this trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RadiofrequencyThe application of RF was through Tecatherap-VIP unit (VIP-Eletromedicina, Argentina) with bipolar method, using a gauntlet of 2cm, and the coupling electrode, which was located in the sacral region (fig x). For the application, participants were placed in a supine position with legs in lithotomy position, it was used water soluble gel for coupling and slide of the gauntlet. The application in external labia majora was made in the caudal-cranial direction, with constant movement and electrode lightly pressed. (fig) During the session, the heat level was monitored verbally and by infrared digital thermometer. The intensity was gradually increased, and at the time when the temperature reached values between 39-41ºC, the intensity was reduced two points and the procedure was maintained for two minutes. | Device | Radiofrequency |
| Radiofrequency - OFFThe treatment protocol for the control group was identical, differing only in relation to the RF equipment, which was turned off, but a water-soluble gel was used, heated by a resistor, preventing the patient from knowing to which group she belonged. Just the physiotherapist who performed the procedure knew which group the patient belonged to. | Device | Radiofrenquency Off |
Primary outcome
clinical response
Time frame: 2 months
To evaluate the clinical response at radio frequencies of large labia region through the pictures before and after ( assessed by a physiotherapist , gynecologist and dermatologist ).
Patient satisfaction
Time frame: 2 months
Patient satisfaction: The response to treatment will be categorized in the absence of improvement; improvement or worsening .
1 secondary outcome
Function Sexual
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia V Lordelo, PhD principal investigator
Centro de Atenção ao Assoalho Pélvico - BAHIANA
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Radiofrequency and Radiofrequency - OFF in people with Dissatisfaction Appearance of the External Genitalia, run by Centro de Atenção ao Assoalho Pélvico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical response (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2015.