Back to resultsEvaluating the Efficacy of Temperature-controlled Radiofrequency (TRF) in the Treatment of Vulvovaginal Atrophy.
Primary Purpose
Postmenopausal Vulvovaginal Atrophy
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
high frequency fulguration equipment
promestriene vaginal soft capsules
Sponsored by
About this trial
This is an interventional treatment trial for Postmenopausal Vulvovaginal Atrophy focused on measuring vulvovaginal atrophy, temperature-controlled radiofrequency, postmenopausal woman, Genitourinary Syndrome of Menopause
Eligibility Criteria
Inclusion Criteria:
- 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.
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.
Sites / Locations
- Peking University People's UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
TRF group
Estriol group
Arm Description
the group who treated with temperature controlled radiofrequency
the group who treated with promestriene vaginal soft capsules
Outcomes
Primary Outcome Measures
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 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.
Secondary Outcome Measures
The changes of vaginal health index score (VHI) compared with baseline
VHI scores accounted for the following five parameters: elasticity, fluid volume, pH, epithelial integrity, and moisture. Each parameter will be graded from 1 (worst condition) to 5 (best condition) with a maximum possible score of 25 points. Scores less than 15 are indicative of vaginal atrophy.
The changes of female sexual function index score (FSFI) compared with baseline
Sexual function will be measured using the Female Sexual Function Index (FSFI). This questionnaire, which contains 19 items, was developed as a brief, but multidimensional, self-reporting instrument to assess the key dimensions of female sexual function. It was developed based on a group of normal female controls and age-matched women who met the DSM-IV-TR criteria for female sexual arousal disorder (FSAD). The FSFI addresses six domains of sexual function (desire, arousal, lubrication, orgasm, satisfaction, and pain) and provides full-scale scores ranging from 2.0 (severe dysfunction) to 36.0 (absence of dysfunction). The validated FSFI version for the Chinese language will be used. A cutoff score of 26.55 will be used to differentiate the presence or absence of sexual dysfunction.
The changes of visual analogue score (VAS) compared with baseline
The Visual Analogue Scale (VAS) is a popular tool for the measurement of pain. The pain is represented by 11 Numbers from 0 to 10, 0 is painless and 10 is the most painful. The patient chooses one of these 11 Numbers to represent the pain level according to her own pain level.
Full Information
NCT ID
NCT04657536
First Posted
October 8, 2020
Last Updated
March 19, 2021
Sponsor
Peking University People's Hospital
Collaborators
Chinese Association of Plastics and Aesthetics
1. Study Identification
Unique Protocol Identification Number
NCT04657536
Brief Title
Evaluating the Efficacy of Temperature-controlled Radiofrequency (TRF) in the Treatment of Vulvovaginal Atrophy.
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 8, 2020 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University People's Hospital
Collaborators
Chinese Association of Plastics and Aesthetics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postmenopausal Vulvovaginal Atrophy
Keywords
vulvovaginal atrophy, temperature-controlled radiofrequency, postmenopausal woman, Genitourinary Syndrome of Menopause
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TRF group
Arm Type
Experimental
Arm Description
the group who treated with temperature controlled radiofrequency
Arm Title
Estriol group
Arm Type
Active Comparator
Arm Description
the group who treated with promestriene vaginal soft capsules
Intervention Type
Device
Intervention Name(s)
high frequency fulguration equipment
Other Intervention Name(s)
temperature controlled radiofrequency
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
promestriene vaginal soft capsules
Other Intervention Name(s)
Estriol
Intervention Description
Promestriene vaginal soft capsules（Zhejiang Anbao Pharmaceutical Co. LTD）will be used 10mg once a day for continuous 20 days.
Primary Outcome Measure Information:
Title
The change value of vaginal maturation index (VMI) compared with baseline
Description
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.
Time Frame
The two groups will be visited on day 0, 1 month and 3 months after the last treatment.
Title
the changes of vaginal symptoms and signs scores compared with baseline
Description
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.
Time Frame
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 Outcome Measure Information:
Title
The changes of vaginal health index score (VHI) compared with baseline
Description
VHI scores accounted for the following five parameters: elasticity, fluid volume, pH, epithelial integrity, and moisture. Each parameter will be graded from 1 (worst condition) to 5 (best condition) with a maximum possible score of 25 points. Scores less than 15 are indicative of vaginal atrophy.
Time Frame
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.
Title
The changes of female sexual function index score (FSFI) compared with baseline
Description
Sexual function will be measured using the Female Sexual Function Index (FSFI). This questionnaire, which contains 19 items, was developed as a brief, but multidimensional, self-reporting instrument to assess the key dimensions of female sexual function. It was developed based on a group of normal female controls and age-matched women who met the DSM-IV-TR criteria for female sexual arousal disorder (FSAD). The FSFI addresses six domains of sexual function (desire, arousal, lubrication, orgasm, satisfaction, and pain) and provides full-scale scores ranging from 2.0 (severe dysfunction) to 36.0 (absence of dysfunction). The validated FSFI version for the Chinese language will be used. A cutoff score of 26.55 will be used to differentiate the presence or absence of sexual dysfunction.
Time Frame
The two groups will be visited on day 0, 1 month and 3 months after the last treatment.
Title
The changes of visual analogue score (VAS) compared with baseline
Description
The Visual Analogue Scale (VAS) is a popular tool for the measurement of pain. The pain is represented by 11 Numbers from 0 to 10, 0 is painless and 10 is the most painful. The patient chooses one of these 11 Numbers to represent the pain level according to her own pain level.
Time Frame
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.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lijun Zhao, Dr.
Phone
0086-10-88324384
Email
lilyzhaopku@163.com
Facility Information:
Facility Name
Peking University People's University
City
Peking
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lijun Zhao, Dr.
Email
lilyzhaopku@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluating the Efficacy of Temperature-controlled Radiofrequency (TRF) in the Treatment of Vulvovaginal Atrophy.
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