New Non-Hormonal Treatment by Radiofrequency for Vulvo-Vaginal Atrophy (ViViA)

March 9, 2022 updated by: Serge Rozenberg

Thermal Treatment of Vulvo-vaginal Atrophy (VVA) Using Novel Low-energy Dynamic Quadripolar Radio-Frequency (DQRF)

Vulvo-Vaginal Atrophy (VVA) or Genitourinary Syndrome of Menopause (GSM) is a common and under-reported condition associated with decreased estrogenization of the vaginal tissue The aim of this study is to evaluate safety and efficacy of " Dynamic Quadripolar Radio-frequency" thermal treatment with Vaginal Dynamic Radio-frequency (VDR™) and Radio-frequency Safety System (RSS™) for the treatment of VVA and GSM in postmenopausal women who either present contra-indication for menopause hormone therapy, or are not willing to use Menopause Hormone Therapy (MHT) or have failed to be helped using MHT.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium
        • Hopital Erasme
      • Brussels, Belgium
        • CHU Brugmann
      • Brussels, Belgium
        • CHU Saint-Pierre
      • Brussels, Belgium
        • Hôpitaux IRIS Sud
      • Brussels, Belgium
        • Jules Institute Bordet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Postmenopausal women suffering of Vulvo-Vaginal atrophy (VVA), included Breast Cancer survivors defined as having self-identified at least one mild to severe of the following symptoms:

    1. Vaginal dryness (none, mild, moderate or severe),
    2. Vaginal and/or vulvar irritation/itching (none, mild, moderate or severe),
    3. Vaginal pain associated with sexual activity (none, mild, moderate or severe)

  • Postmenopausal women with VVA confirmed by at least one of the following criteria:

    1. A proportion of superficial cells ≤ 5% in the vaginal smear using a "Maturation Index"
    2. A vaginal pH > 5
  • Postmenopausal women between 40 and 75 years of age (non hysterectomized or hysterectomized). Menopause will be assessed either by amenorrhea of > 1 year and / or by Follicle Stimulating Hormone (FSH) > 30 UI/L and estradiol (E2) < 20 pg/ml
  • They must have either a contraindication to hormonal therapies, a failure of previous use of hormonal therapies (either systemic and/or local) or must have refused to take hormonal therapy.
  • Willing to participate in the study and sign an informed consent.

Exclusion Criteria:

  • Undiagnosed abnormal genital bleeding.
  • The administration of any investigational drug within 30 days of screening visit.
  • Endometrial hyperplasia at biopsy performed at screening or endometrial cancer.
  • Use of estrogens/progestins products (vaginal, oral, pellet, transdermal....) in the 4 weeks to months (depending on the product used) prior study entry.
  • Presence of severe medical disease or neurological disease or important co-morbidities.
  • Other gynaecological malignancies.
  • Recent vaginal surgery .
  • A clinically relevant prolapse (Pelvic Organ Prolapse-Quantification System (POP-Q) ≤ 2)
  • Current urinary tract or vaginal infection or recent sexually transmitted disease
  • Anticoagulant treatment
  • People with pacemakers and/or other implanted electrodes (Intra-Uterine Device (IUD) and surgical pelvic implants for sterilization are not considered as contraindication)
  • Disabled people unable to communicate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control Group : pH-Cream
Control Group will be only treated with a fixed amount (1g) of pH-cream (Cetomacrogol cream) to self-administered with a vaginal applicator for 12 weeks (one dose every three days and if deem necessary, additional doses can be applied and notified in the calendar provided).
Drug: pH-Cream
1g of Cetomacrogol cream (pH-cream) to self-administered with a vaginal applicator for 12 weeks (one dose every three days)
Other Names:
  • Cetomacrogol cream
Experimental: Dynamic Quadripolar Radio-Frequency treatment

Experimental Group will be treated with Dynamic Quadripolar Radio-Frequency (DQRF) (with Eva™ Device) for 8 weeks (+ 4 weeks). The Dynamic Quadripolar Radio-frequency sessions will involve -5 sessions (one every 14-21 days), if necessary External treatment (vulvar - will be applied before internal treatment for more comfort) : 10 minutes (5 minutes left side, 5 minutes right side), and Internal treatment (VVA, Vaginal Laxity, Mild-Stress Urinary Incontinence (SUI)): 20 minutes.

In parallel, patients can also apply pH-cream (Cetomacrogol cream) (one dose of 1g) if they judge necessary but they are not allowed to use it during the seven days before radiofrequency session. If they use pH-cream, they must notify it in the calendar provided.
Drug: pH-Cream
1g of Cetomacrogol cream (pH-cream) to self-administered with a vaginal applicator for 12 weeks (one dose every three days)
Other Names:
  • Cetomacrogol cream
Device: Dynamic Quadripolar Radio-Frequency treatment
Novel low-energy "Dynamic Quadripolar Radio-frequency" thermal treatment through Eva™ Device. Eva™ Device combines both advanced VDR™ technology (Vaginal Dynamic Radiofrequency) and RSS™ (Radiofrequency Safely System) technology.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline to week 12 (+4 weeks) of self-assessment of the most bothersome symptom dyspareunia, evaluated by a questionnaire
Time Frame: Up to 12 (+4 weeks) week after beginning of treatment
The severity of dyspareunia recorded as none, mild, moderate or severe (score values of 0, 1, 2 or 3, respectively). Data obtained at baseline and week 12 (+4 weeks).
Up to 12 (+4 weeks) week after beginning of treatment
Change from baseline to week 12 (+4 weeks) of vaginal cell maturation (Maturation Index).
Time Frame: Up to 12 (+4 weeks) week after beginning of treatment
The percentage of parabasal, superficial, intermediate cells will be determined from the vaginal smears collected during the study at baseline and week 12 (+4 weeks). The maturation index is the proportion of these 3 types of cells in each 100 cells counted on a smear.
Up to 12 (+4 weeks) week after beginning of treatment
Change from baseline to week 12 (+4 weeks) of vaginal pH
Time Frame: Up to 12 (+4 weeks) week after beginning of treatment
A pH strip will be applied directly to the lateral wall of the vagina using forceps. The change in color of the pH indicator strip will be compared to the color chart for pH evaluation.Data obtained at baseline and week 12 (+4 weeks)
Up to 12 (+4 weeks) week after beginning of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline to week 12 (+4 weeks) of the "Vaginal Health Index" (VHI)
Time Frame: Up to 12 (+4 weeks) week after beginning of treatment
Evaluation of each of the four following signs of atrophy, which constitute together the Vaginal Health Index" (VHI). Vaginal Secretions, Vaginal Epithelial Integrity, Vaginal Epithelial Surface Thickness, Vaginal Color will be evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy and will be analyzed using the score values of 1, 2, 3 and 4, respectively. The visual evaluation of the vagina (petechiae, pallor, friability and dryness or redness in vaginal mucosa) will be assessed using the pictures by the physician blinded to the treatment. Data will be obtained at baseline and week 12 (+4 weeks).
Up to 12 (+4 weeks) week after beginning of treatment
Change from baseline to week 12 (+4 weeks) of the vulvovaginal symptoms
Time Frame: Up to 12 (+4 weeks) week after beginning of treatment
The vulvovaginal symptoms will be evaluated by a 'vulvovaginal symptoms questionnaire" in postmenopausal women at baseline and week 12 (+4 weeks).
Up to 12 (+4 weeks) week after beginning of treatment
Change from baseline to week 12 (+4 weeks) in the two groups of the "Female Sexual Function Index (FSFI)
Time Frame: Up to 12 (+4 weeks) week after beginning of treatment
The Female Sexual Function Index is measured by a questionnaire evaluating self-reported sexual functioning during the previous month. This includes 19 items grouped within six central domains: desire (items 1 and 2), arousal (items 3 to 6), lubrication (items 7 to 10), orgasm (items 11 to 13), global sexual and relationship satisfaction (items 14 to 16), and pain (items 17 to 19). Each domain was scored on a scale of 0 to 6 with lower scores indicating lower sexual functioning. A domain score of 0 indicated that the women reported no sexual activity. The individual domain scores were then totaled and multiplied by a predetermined factor to weight each domain equally.
Up to 12 (+4 weeks) week after beginning of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Serge Rozenberg

Collaborators

Jules Bordet Institute
Erasme University Hospital
NOVAVISION GROUP S.P.A
Centre Hospitalier Universitaire Brugmann
Hopitaux Iris Sud

Investigators

  • Principal Investigator: Serge Rozenberg, MD,PhD, Centre Hospitalier Universitaire Saint Pierre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2019

Primary Completion (Actual)

December 8, 2021

Study Completion (Actual)

December 8, 2021

Study Registration Dates

First Submitted

February 26, 2019

First Submitted That Met QC Criteria

February 26, 2019

First Posted (Actual)

February 28, 2019

Study Record Updates

Last Update Posted (Actual)

March 24, 2022

Last Update Submitted That Met QC Criteria

March 9, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B076201938646

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Anonymized data will be shared and will be available on a website at the end of the study. The website where the data will be hosted, has not been yet decided.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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