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

Sponsor
Serge Rozenberg (Other)
Overall Status
Terminated
CT.gov ID
NCT03857893
Collaborator
NOVAVISION GROUP S.P.A (Other), Jules Bordet Institute (Other), Erasme University Hospital (Other), Centre Hospitalier Universitaire Brugmann (Other), Hôpitaux IRIS Sud (Other)
53
Enrollment
5
Locations
2
Arms
33.3
Actual Duration (Months)
10.6
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Dynamic Quadripolar Radio-Frequency treatment
  • Drug: pH-Cream
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
53 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Thermal Treatment of Vulvo-vaginal Atrophy (VVA) Using Novel Low-energy Dynamic Quadripolar Radio-Frequency (DQRF)
Actual Study Start Date :
Mar 1, 2019
Actual Primary Completion Date :
Dec 8, 2021
Actual Study Completion Date :
Dec 8, 2021

Arms and Interventions

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.

    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.

    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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change from baseline to week 12 (+4 weeks) of self-assessment of the most bothersome symptom dyspareunia, evaluated by a questionnaire [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).

    2. Change from baseline to week 12 (+4 weeks) of vaginal cell maturation (Maturation Index). [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.

    3. Change from baseline to week 12 (+4 weeks) of vaginal pH [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)

    Secondary Outcome Measures

    1. Change from baseline to week 12 (+4 weeks) of the "Vaginal Health Index" (VHI) [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).

    2. Change from baseline to week 12 (+4 weeks) of the vulvovaginal symptoms [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).

    3. Change from baseline to week 12 (+4 weeks) in the two groups of the "Female Sexual Function Index (FSFI) [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 75 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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) ≤

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHU Brugmann Brussels Belgium
    2 CHU Saint-Pierre Brussels Belgium
    3 Hôpital Erasme Brussels Belgium
    4 Hôpitaux Iris Sud Brussels Belgium
    5 Jules Institute Bordet Brussels Belgium

    Sponsors and Collaborators

    • Serge Rozenberg
    • NOVAVISION GROUP S.P.A
    • Jules Bordet Institute
    • Erasme University Hospital
    • Centre Hospitalier Universitaire Brugmann
    • Hôpitaux IRIS Sud

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Serge Rozenberg, Head of Gynecology Department, Centre Hospitalier Universitaire Saint Pierre
    ClinicalTrials.gov Identifier:
    NCT03857893
    Other Study ID Numbers:
    • B076201938646
    First Posted:
    Feb 28, 2019
    Last Update Posted:
    Mar 24, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Serge Rozenberg, Head of Gynecology Department, Centre Hospitalier Universitaire Saint Pierre
    Vulvo-vaginal atrophy
    Dynamic Quadripolar Radio-Frequency
    Menopause
    Genitourinary syndrome of menopause
    Additional relevant MeSH terms:
    Atrophy

    Study Results

    No Results Posted as of Mar 24, 2022