Radiofrequency Female External Genital Region: a Clinical Trial

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 Overview

• Status: Completed
• Conditions: Dissatisfaction Appearance of the External Genitalia
• Intervention / Treatment: Device: Radiofrequency; Device: Radiofrequency - OFF

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• were included women aged between 18 and 60 years with unsatisfied the appearance of the external genital, attending the clinical physiotherapy, Bahia, Brazil

Exclusion Criteria:

• Pregnant women, women that were using copper IUD, as well as other with skin lesions in the genital region were excluded from this trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Radiofrequency; Eight RF sessions were performed, with an interval of seven days between them. The application of Radiofrequency in the external genitalia.	Device: Radiofrequency; 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.
Sham Comparator: Radiofrenquency Off; 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	Device: Radiofrequency - OFF; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 ).	2 months
Patient satisfaction	Patient satisfaction: The response to treatment will be categorized in the absence of improvement; improvement or worsening .	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 months

Collaborators and Investigators

• Sponsor: Centro de Atenção ao Assoalho Pélvico
• Investigators: Principal Investigator: Patricia V Lordelo, PhD, Centro de Atenção ao Assoalho Pélvico - BAHIANA

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: November 4, 2015
• First Submitted That Met QC Criteria: November 19, 2015
• First Posted (Estimate): November 23, 2015

Study Record Updates

• Last Update Posted (Estimate): November 23, 2015
• Last Update Submitted That Met QC Criteria: November 19, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: Treatment by Pulsed Radio Frequency, Collagen, Female
• Other Study ID Numbers: U1111-1148-8313

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No