Randomized Multicenter Clinical Trial for Evaluating the Efficacy of Temperature-controlled Radiofrequency Compared With Topical Estriol in the Treatment of Vulvovaginal Atrophy in Postmenopausal Women
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The change value of vaginal maturation index (VMI) compared with baseline
研究概览
简要总结
This project will be a prospective, multicenter, randomized cohort study. The investigators will select patients with vulvovaginal atrophy who have indications for treatment, and set up the experimental group (Peninsula temperature-controlled radiofrequency therapeutic apparatus group) and the control group (promestriene vaginal soft capsules group). Changes in vaginal exfoliated cell maturity index (MV), score of vaginal symptoms and signs, vaginal health index score (VHIS), female sexual function index score (FSFI), visual analogue score (VAS) before and after treatment, and adverse effects will be observed to analyze the safety and efficacy of temperature-controlled radiofrequency therapy for vulvovaginal atrophy in postmenopausal women.
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
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Menopausal time at least one year.
- •Genitourinary Syndrome of Menopause (GSM) related symptoms with moderate or severe intensity, such as dryness and dyspareunia, etc.
- •Blood FSH≥30 IU/L (30mIU/mL)。
- •Clinical symptoms and signs of vaginal atrophy score≥
- •Breast ultrasound examination was grade 1-3 within 9 months before the study.
- •Voluntary participation in clinical trials and signed informed consent.
- •Patients followed the treatment regimen and completed the study.
- •Exclusion Criteria (one of the following criteria is excluded) :
- •The patients who did not meet the inclusion criteria
- •Received Estrogen replacement therapy (including local and systemic medication) within 3 months.
- •Received any medicine (such as Baofukang suppository) to treat vulvovaginal atrophy within 3 months.
- •Corticosteroids were used within 6 weeks. Long-term corticosteroids were used (intermittent nasal or skin application, eye drops and ears are allowed).
- •Other experimental drugs were used within 1 month.
- •Received vaginal laser therapy within 6 months.
- •Patients with acute urinary tract infection;
- •Patients with acute genital tract infection (genital herpes, trichomonad, fungal vaginitis; gonococcus, mycoplasma, chlamydia infection and bacterial vaginosis, etc.);
- •Patients with pelvic organ prolapse greater than or equal to stage II;
- •Patients with metal intrauterine device (IUD)；
- •Patients with precancerous lesions or malignant tumors of vagina and cervix;
- •Patients with serious heart, liver, brain, kidney, endocrine diseases, etc.
- •Allergic to control drug and excipients.
- •Other malignancies are known or suspected.
- •With estrogen-dependent neoplasm.
- •Confirm a history of depression or serious mental illness.
- •There were consciousness barriers and communication barriers that could not cooperate with the experiment.
- •Patients considered unsuitable for this clinical trial.
排除标准
- 未提供
研究组 & 干预措施
Estriol group
the group who treated with promestriene vaginal soft capsules
干预措施: promestriene vaginal soft capsules (Drug)
TRF group
the group who treated with temperature controlled radiofrequency
干预措施: high frequency fulguration equipment (Device)
结局指标
主要结局
The change value of vaginal maturation index (VMI) compared with baseline
时间窗: The two groups will be visited on day 0, 1 month and 3 months after the last treatment.
The Vaginal Maturation Index (VMI) is an assessment done to establish the oestrogen effect in the body. The vaginal cytology specimens were collected from the mid-vaginal-wall before treatment and fixed in ThinPrep solution. The VMI is a ratio obtained with three main cell types found in the vaginal walls: parabasal cells(P), Intermediate cells (I) and superficial cells(S). The findings will be presented in a 0/0/0 format. VMI = \[1 × (% superficial cells)\] + \[0.6 × (% intermediate cells)\] + \[0.2 × (% parabasal cells)\]. This index enabled us to objectively evaluate the differential count of each cell group expressed as a percentage. The greater the degree of vaginal atrophy, the greater the estrogen deficiency. When at most 30% of the deep cells were present in the vaginal smears, mild hypoestrogenism was diagnosed. A deep cell percentage between 30% and 49% indicated moderate hypoestrogenism and a more than 50% deep cell percentage indicated hypoestrogenism.
the changes of vaginal symptoms and signs scores compared with baseline
时间窗: The two groups will be visited on day 0, day 20（the control group is day 21），1 month and 3 months after the last treatment.
Symptoms (vaginal dryness, pruritus, burning, pain, shallow dyspareunia, deep dyspareunia) will be individually scored by women and signs (vaginal mucosa and petechia, vaginal elasticity, mucosal luster) will be individually scored by the investigators as 0 = absence, 1 = mild, 2 = moderate, and 3 = severe alteration. In addition, a composite score of symptoms and signs will calculated by the addition of the intensity scores of all individual symptoms and signs (range, 0-27: The higher the score is, the more severe the genitourinary atrophy is.). Symptoms and signs score (SSC) will be obtained at each visiting to assess the effect of treatment on all individual.
次要结局
- The changes of vaginal health index score (VHI) compared with baseline(The two groups will be visited on day 0, day 20（the control group is day 21），1 month and 3 months after the last treatment.)
- The changes of female sexual function index score (FSFI) compared with baseline(The two groups will be visited on day 0, 1 month and 3 months after the last treatment.)
- The changes of visual analogue score (VAS) compared with baseline(The two groups will be visited on day 0, day 20（the control group is day 21），1 month and 3 months after the last treatment.)
研究者
Zhaolijun
associate professor
Peking University People's Hospital