Evaluating the Efficacy of Temperature-controlled Radiofrequency (TRF) in the Treatment of Vulvovaginal Atrophy.
NCT ID: NCT04657536
Last Updated: 2021-03-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
200 participants
INTERVENTIONAL
2020-12-08
2021-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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TRF group
the group who treated with temperature controlled radiofrequency
high frequency fulguration equipment
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.
Estriol group
the group who treated with promestriene vaginal soft capsules
promestriene vaginal soft capsules
Promestriene vaginal soft capsules（Zhejiang Anbao Pharmaceutical Co. LTD）will be used 10mg once a day for continuous 20 days.
Interventions
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high frequency fulguration equipment
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.
promestriene vaginal soft capsules
Promestriene vaginal soft capsules（Zhejiang Anbao Pharmaceutical Co. LTD）will be used 10mg once a day for continuous 20 days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
* 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.
40 Years
75 Years
FEMALE
No
Sponsors
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Chinese Association of Plastics and Aesthetics
UNKNOWN
Peking University People's Hospital
OTHER
Responsible Party
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Zhaolijun
associate professor
Locations
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Peking University People's University
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Version 2.0；20200221
Identifier Type: -
Identifier Source: org_study_id
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