Genitourinary Syndrome of Menopause, Vulvo-vaginal Atrophy
Conditions
Keywords
Vulvo-vaginal atrophy, Dynamic Quadripolar Radio-Frequency, Menopause, Genitourinary syndrome of menopause
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.
Interventions
DEVICEDynamic 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.
DRUGpH-Cream
1g of Cetomacrogol cream (pH-cream) to self-administered with a vaginal applicator for 12 weeks (one dose every three days)
Sponsors
NOVAVISION GROUP S.P.A
Jules Bordet Institute
Erasme University Hospital
Centre Hospitalier Universitaire Brugmann
Hôpitaux IRIS Sud
Serge Rozenberg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 75 Years
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) ≤ 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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). |
| 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. |
Countries
Belgium
Outcome results
None listed