Radiofrequency Female External Genital Region: a Clinical Trial

Centro de Atenção ao Assoalho Pélvico

Status and phase: Completed; Phase 2

Conditions: Dissatisfaction Appearance of the External Genitalia

Treatments: Device: Radiofrequency; Device: Radiofrequency - OFF

Study type: Interventional

Funder types: Other

Identifiers

NCT02611791

U1111-1148-8313

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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42 participants in 2 patient groups

Radiofrequency

Experimental group

Description:

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

Treatment:

Device: Radiofrequency

Radiofrenquency Off

Sham Comparator group

Description:

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

Treatment:

Device: Radiofrequency - OFF