Radiofrequency Female External Genital Region: a Clinical Trial
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Dissatisfaction Appearance of the External Genitalia
- Sponsor
- Centro de Atenção ao Assoalho Pélvico
- Enrollment
- 42
- Primary Endpoint
- clinical response
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
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 .
Secondary Outcomes
- Function Sexual(2 months)