Evaluating the Efficacy of Temperature-controlled Radiofrequency (TRF) in the Treatment of Vulvovaginal Atrophy.

NCT04657536 | Unknown

• 1 other identifier: Version 2.0；20200221
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postmenopausal Vulvovaginal Atrophy

Keywords

vulvovaginal atrophy; temperature-controlled radiofrequency; postmenopausal woman; Genitourinary Syndrome of Menopause

Outcome Measures

Primary Outcomes (2)

• The change value of vaginal maturation index (VMI) compared with baseline

  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 two groups will be visited on day 0, 1 month and 3 months after the last treatment.

• the changes of vaginal symptoms and signs scores compared with baseline

  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.

  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.

Secondary Outcomes (3)

• 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.

Study Arms (2)

TRF group

EXPERIMENTAL

the group who treated with temperature controlled radiofrequency

Device: high frequency fulguration equipment

Estriol group

ACTIVE COMPARATOR

the group who treated with promestriene vaginal soft capsules

Drug: promestriene vaginal soft capsules

Interventions

high frequency fulguration equipment DEVICE

All subjects will be carried out with 3 standard protocol TRF treatments to the vulvovaginal tissue using the high frequency fulguration equipment (Shenzhen Peninsula Medical co., Ltd) at 10-day to 15-day intervals. Radiofrequency energy was applied to the vaginal canal through a specialized probe combining monopolar and bipolar treatment modes. Monopolar treatment mode is for 15 minutes. Aim the three indication points A, B and C on the probe to the direction of 12 o'clock in turn. Each area should be treated for about 5 minutes. Rotate the probe clockwise when changing the area for treatment.Bipolar treatment mode is for 10 minutes. Firstly, indication point A is aimed to 12 o'clock for 5-minutes treatment and then the probe is rotated 90°clockwise for another 5-minutes treatment. The power setting will be 35-40w, and the target temperature setting will be 40 to 45℃, titrated to subject tolerance.

Also known as: temperature controlled radiofrequency

TRF group

promestriene vaginal soft capsules DRUG

Promestriene vaginal soft capsules（Zhejiang Anbao Pharmaceutical Co. LTD）will be used 10mg once a day for continuous 20 days.

Also known as: Estriol

Estriol group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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≥15.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University People's Hospital: lead
• Chinese Association of Plastics and Aesthetics: collaborator

Study Sites (1)

Peking University People's University

Beijing, Beijing Municipality, 100044, China

RECRUITING

MeSH Terms

Interventions

Estriol

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Central Study Contacts

Lijun Zhao, Dr.

CONTACT

0086-10-88324384; lilyzhaopku@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: October 8, 2020
• First Posted: December 8, 2020
• Study Start: December 8, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: March 22, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)