Microablative Radiofrequency in the Treatment of Urinary Symptoms Associated With Genitourinary Syndrome of Menopause: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Resolution or improvement of episodes of urinary loss assessed by pad test
研究概览
简要总结
Genitourinary Syndrome fo Menopause (GSM) is made up of a set of changes in the region of the vulva, vagina and lower urinary tract associated with a decrease in estrogen levels in the urogenital tissue, which leads to a reduction in blood supply, disorders in collagen metabolism and skin elasticity. The standard treatment for urinary incontinence during menopause is pelvic floor muscle training, associated or not with local hormone replacement therapy. Although low cost and easy to access, it is associated with low patient's adherence. Physical methods such as laser and radiofrequency in non-ablative, ablative and microablative forms are technologies that have recently been used in the vaginal mucosa to promote neoelastogenesis and neocollagenesis. It is hypothesized that menopausal women, who present symptoms of GSM, may benefit from this new, minimally invasive resource (microablative radiofrequency). This is a randomized clinical trial in which women aged between 40 and 65 years old will be included with clinical complaints of urinary symptoms associated with GSM. A basic anamnestic questionnaire will be used as the study instrument to collect sociodemographic, clinical data and symptoms, following the routine and standard of the service. To evaluate the treatment, the following will be used: voiding diary, pad test, vaginal cytology, histopathology, Female Sexual Function Index (FSFI), Short-Form Health Survey - SF-36 Questionnaire, King's Health Questionnaire, evolution of symptoms (dryness, pain during sexual activity, vaginal laxity, itching, burning sensation and pain in the vaginal introitus) and level of patient's satisfaction. Patients will be randomized into: group 1 or control group, which will perform pelvic floor muscle training, PFMT, with supervision (three times) and at home twice a day, and group 2 or test group, which will perform the same PFMT protocol associated with vaginal microablative radiofrequency. 10% lidocaine spray will be applied three minutes before the procedure and three applications will be made to the vagina/vaginal introitus, with an interval of 30 to 40 days. The purpose of this study is to test the efficacy and duration of effect of microablative radiofrequency in the treatment of urinary symptoms associated with GSM.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Clinical complaint of urinary incontinence associated to Genitourinary Syndrome of Menopause.
- •Negative cervical oncotic cytology, within the last 3 years.
排除标准
- •Patients with cognitive deficit;
- •Patients with chronic degenerative neurological diseases;
- •Post-void residue greater than 50 ml;
- •Carriers of a pacemaker and implantable cardioverter defibrillator;
- •Use of hormonal therapy (topical or systemic) starting in the 2 months prior to the initial assessment;
- •Patients undergoing brachytherapy or pelvic radiotherapy;
- •Patients that had reconstructive pelvic surgery;
- •Pregnant women.
结局指标
主要结局
Resolution or improvement of episodes of urinary loss assessed by pad test
时间窗: Before the beginning of the treatment, 30 days after the end of treatment and 12 months after the end of the treatment.
Participants will perform the one-hour Pad Test to diagnose and quantify urinary loss. Initially, the absorbent will be placed in a closed plastic bag and weighed on a precision electronic scale (Denver Instrument®). Then, the participant will be instructed to put on the pad, drink 500 ml of water in a maximum of 15 minutes and remain at rest for another 15 minutes, this phase represents 30 minutes of the test. In the other 30 minutes, the participant will be asked to perform certain standardized activities simulating activities of daily life (going up and down stairs, sitting down and standing up ten times, coughing ten times, picking up objects from the floor five times, running in the same place for one minute and washing the hands under running water for one minute).
Resolution or improvement of episodes of urinary loss assessed by urinary diary
时间窗: Before the beginning of the treatment, 30 days after the end of treatment and 12 months after the end of the treatment
Participants will be instructed to keep a voiding diary at home for three days to record water intake, urinary volume and the number of incontinence episodes, as well as episodes of urgency and nocturnal enuresis.
Number of patients with tolerability related to treatment assessed by Likert Scale.
时间窗: At each of the three sessions (every 30 to 40 days), 30 days after the end of treatment and 12 months after the end of the treatment.
Likert scale of 3 points will be asked to the patients: 1) impossible to tolerate the treatment, 2) not nice, but possible to tolerate, 3) very tolerable.
Number of patients with adverse effects related to treatment assessed by histopathology.
时间窗: Before the beginning of the treatment, 30 days after the end of treatment and 12 months after the end of the treatment.
To evaluate the safety in tissue effect of FRAXX, samples of vaginal tissue will be obtained through a biopsy taken from the lateral walls, in the middle third of the vagina, for histopathological study. Procedure carried out under colposcopic vision, using a 3mm loop attached to the radiofrequency device, "surgery" mode, removing a small vaginal fragment.
Resolution or improvement of episodes of urinary loss assessed by questionnaire.
时间窗: Before the beginning of the treatment, 30 days after the end of treatment and 12 months after the end of the treatment.
The questionnaire to be used will be International Consultation on Incontinence Questionnaire- Short Form (ICIQ-SF) which is a self-administered questionnaire that assesses the impact of UI on quality of life and the classification of urinary loss. The ICIQ-SF is composed of four questions that assess the frequency, severity and impact of UI, in addition to a set of eight self-diagnosis items, related to the causes or situations of UI experienced by patients. The higher the score, the greater the severity of urinary incontinence and the greater the impact on the patient's quality of life.
次要结局
- Improvement of Sexual Function assessed by Female Sexual Function Index(Before the beginning of the treatment, 30 days after the end of treatment and 12 months after the end of the treatment)
- Improvement of quality of life assessed by Short-Form Health Survey (SF-36)(Before the beginning of the treatment, 30 days after the end of treatment and 12 months after the end of the treatment)
- Recovery of vaginal health assessed by Vaginal Index Maturation(Before the beginning of the treatment, 30 days after the end of treatment and 12 months after the end of the treatment)
- Recovery of vaginal health assessed by vaginal pH(Before the beginning of the treatment, 30 days after the end of treatment and 12 months after the end of the treatment)
- Improvement or resolution of urinary incontinence and the impact on quality of life assessed by King's Health Questionnaire.(Before the beginning of the treatment, 30 days after the end of treatment and 12 months after the end of the treatment)
- Evolution of vaginal symptoms assessed by Visual Analogue Scale (VAS)(Immediately after the initial physical examination and at the end of each of the three session (every 30 to 40 days).)
- Degree of patient satisfaction using a five-point Likert scale.(Before the beginning of the treatment, 30 days after the end of treatment and 12 months after the end of the treatment)
研究者
Patricia Lordelo
Head of the CentroAAP
Centro de Atenção ao Assoalho Pélvico