Radiofrequency Female External Genital Region: a Clinical Trial

Phase 2

Completed

• Conditions: Dissatisfaction Appearance of the External Genitalia
• Interventions: Device: Radiofrequency; Device: Radiofrequency - OFF

• Registration Number: NCT02611791
• Lead Sponsor: Centro de Atenção ao Assoalho Pélvico

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Primary Completion: 2013-12
• Study Completion: 2014-06
• Status Verified: 2015-11
• Study First Submitted: 2015-11-04
• Study First Submitted QC: 2015-11-19
• Last Update Submitted: 2015-11-19
• Study First Posted: 2015-11-23
• Last Update Posted: 2015-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 42

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Radiofrequency	Radiofrequency	Eight RF sessions were performed, with an interval of seven days between them. The application of Radiofrequency in the external genitalia.
Radiofrenquency Off	Radiofrequency - 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

Primary Outcome Measures

Name	Time	Method
clinical response	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	2 months	Patient satisfaction: The response to treatment will be categorized in the absence of improvement; improvement or worsening .

Secondary Outcome Measures

Name	Time	Method
Function Sexual	2 months	To evaluate the sexual response after treatment by radio frequency changes in the values of the scores(FSFI) before treatment and at the end.