Radiofrequency Female External Genital Region: a Clinical Trial

NCT02611791 | Completed Phase 2

• 1 other identifier: U1111-1148-8313
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Dissatisfaction Appearance of the External Genitalia

Keywords

Treatment by Pulsed Radio Frequency, Collagen, Female

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Function Sexual

  2 months

Study Arms (2)

Radiofrequency

EXPERIMENTAL

Eight RF sessions were performed, with an interval of seven days between them. The application of Radiofrequency in the external genitalia.

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

Device: Radiofrequency - OFF

Interventions

Radiofrequency DEVICE

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

Radiofrequency - OFF DEVICE

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.

Radiofrenquency Off

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Centro de Atenção ao Assoalho Pélvico: lead

Study Officials

• Patricia V Lordelo, PhD

  Centro de Atenção ao Assoalho Pélvico - BAHIANA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2015
• First Posted: November 23, 2015
• Study Start: October 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: June 1, 2014
• Last Updated: November 23, 2015

Record last verified: 2015-11