Radiofrequency Non-ablative in the Treatment of Genitourinary Syndrome of Menopause
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Change in Cell maturation index
研究概览
简要总结
The study is conducted in women at the menopause with a clinical diagnosis of Genitourinary Syndrome, which presents symptoms in of vulvovaginal atrophy and tract urinary and were treated with radiofrequency non ablative technique for capacitive transfer in intra-vaginal. All participants were evaluated by a physical therapist and did the exam of PH vaginal, cell maturation index and questionnaires. The participants made five sessions of Radio Frequency (RF) with an interval of seven days between them. The application of RF was performed by physical therapist trained in the technique of radio frequency through the Capenergie brand device with capacitive transfer method using non-ablative handle with active electrode intra-vaginal and coupling electrode placed on the participant's back. For application, the participants were in gynecological position. The session had an average duration above 20 minutes. The temperature was measured by an infrared thermometer when it reached 41graus radiofrequency was maintained for 2 minutes in the anterior wall and 2 minutes more in the posterior wall of vagina.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •will be women in menopause until 65 years of age with clinical complaints of Genitourinary Syndrome of Menopause and who agree to voluntarily participate in the research.
排除标准
- •will be excluded from the study participants with limited understanding, with neurological degenerative chronic diseases, sensory deficit in the genital region, users of pacemaker and intrauterine device of cooper and women under hormone therapy under six months
结局指标
主要结局
Change in Cell maturation index
时间窗: Each 3 months pos treatment, until one year
% cells parabasal, % intermediate cells and superficial cells
Change in Vaginal PH
时间窗: Each 3 months pos treatment, until one year
During the fertile years of life, the vaginal pH ranges from 3.5 to 4.5. At menopause, vaginal Ph increases to above 4.5. The higher the vaginal Ph, the greater the degree of atrophy
次要结局
- Female Genital Self-image Scale(one week, one month, three months, six months, nine months and one year)
- Questionnaire of quality of life specified urinary incontinence(one week, one month, three months, six months, nine months and one year)
- Numeric Visual Scale(one week, one month, three months, six months, nine months and one year)
- Female Sexual Function Index(one week, one month, three months, six months, nine months and one year)