Radiofrequency Female External Genital Region: a Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 主要终点
- clinical response
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •were included women aged between 18 and 60 years with unsatisfied the appearance of the external genital, attending the clinical physiotherapy, Bahia, Brazil
排除标准
- •Pregnant women, women that were using copper IUD, as well as other with skin lesions in the genital region were excluded from this trial.
结局指标
主要结局
clinical response
时间窗: 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
时间窗: 2 months
Patient satisfaction: The response to treatment will be categorized in the absence of improvement; improvement or worsening .
次要结局
- Function Sexual(2 months)