Photobiomodulation Effect on Vulvovaginal Atrophy in Postmenopausal Women: Randomized and Controlled Trial.
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Objective assessment of improvement in vulvovaginal atrophy symptoms.
研究概览
简要总结
Menopause is a physiological event and is defined as the loss of ovarian follicular activity, with consequent permanent cessation of menstrual cycles. Its diagnosis is made retrospectively after 12 months of amenorrhea, with no pathological cause involved. This period is marked by several changes in the female organism, mainly the genitourinary syndrome (GUS), which is a collection of signs and symptoms resulting from the state of hypoestrogenism. Almost half of postmenopausal women will experience symptoms of GUS, with vaginal dryness being the most prevalent, followed by dyspareunia and vulvovaginal irritation. The aim of the study is to evaluate the effect of photobiomodulation with red LED (ligth emitting diode) on the symptoms of vulvovaginal atrophy in postmenopausal women. A randomized and controlled clinical trial will be developed, which will include postmenopausal women with signs and symptoms of vulvovaginal atrophy. Participants will be allocated into two groups: those who will undergo photobiomodulation with intravaginal LED, and those who will receive vaginal cream with estriol. Objective and subjective improvement of atrophy will be assessed using the Vaginal Health Index and the visual analog scale, respectively. Vaginal pH, cell maturation index and changes in sexual function through the Female Sexual Function Index questionnaire will also be assessed. The variables will be analyzed at the time of admission, in one and three months after the intervention.
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
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •postmenopausal women (amenorrhea for less than 12 months);
- •presence one or more symptoms of vulvovaginal atrophy (dyspareunia, dryness, irritation and vaginal burning);
- •Vaginal Heath Index ≤ 15 (signs of atrophy);
- •normal cytopathology of uterine cervix in the last year.
排除标准
- •previous or current history of gynecological neoplasia;
- •who used hormonal or non-hormonal treatment for vulvovaginal symptoms of menopause;
- •current or recent genitourinary lesions or infectious processes in the genitourinary tract (last month);
- •current or recent (last month) systemic treatment with antifungals, antibiotics or corticosteroids;
- •presence of genital prolapse;
- •presence of contraindications to the use of vaginal estrogen (current, previous or suspected diagnosis of breast cancer, malignant estrogen-dependent tumors, uninvestigated uterine bleeding, untreated endometrial hyperplasia, deep venous thrombosis and current or previous pulmonary thromboembolism, known thrombophilia, recent or active arterial disease, acute liver disease, porphyria, use of drugs that may interact with estriol and hypersensitivity to the components of the vaginal cream formula).
研究组 & 干预措施
Estrogen vaginal cream group (group A)
22 participants will be included in this group. The participants selected for group A will be provided with estriol 0.01% vaginal cream, which should be applied at home.
干预措施: Estrogen vaginal cream group (group A) (Drug)
Photobiomodutation group (group B)
22 participants will be included in this group. The participants selected for group B will be undergo photobiomodulation with red LED.
干预措施: Photobiomodutation group (group B) (Radiation)
结局指标
主要结局
Objective assessment of improvement in vulvovaginal atrophy symptoms.
时间窗: 6 months
Vaginal Health Index: an objective assessment will be performed using the parameters of the Vaginal Health Index, in which elasticity, fluid volume, pH, epithelial integrity and moisture are evaluated. Each aspect evaluated receives a score, which varies from 1 to 5. The score can vary from 5 to 25, being considered a diagnosis of vulvovaginal atrophy when the values are less than or equal to 15. This evaluation will be performed by a qualified gynecologist during the exam physicist.
Subjetive assessment of improvement in vulvovaginal atrophy symptoms.
时间窗: 6 months
Visual Analog scale: the assessment of vulvovaginal atrophy symptoms will be made using the visual analog scale. The patient will receive a ruler with markings from 0 to 10, one end of which indicates complete absence of symptoms and the other indicates the worst possible symptom. This assessment will be applied to each of the symptoms: dyspareunia, dryness, irritation.
次要结局
- Female Sexual Function Index(6 months)
- Vaginal Cell Maturation Index(6 months)
- Vaginal pH(6 months)
研究者
Anna Carolina Ratto Tempestini Horliana
INVESTIGATOR
University of Nove de Julho