Clinical Trials Logo
  1. Home
  2. Other
  3. NCT03857893
  4. Details
NCT03857893 Clinical Trial

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

Genitourinary Syndrome of Menopause Clinical Trial

— ViViA  

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03857893
Other study ID # B076201938646
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date March 1, 2019
Est. completion date December 8, 2021

Study information
Verified date March 2022
Source Centre Hospitalier Universitaire Saint Pierre
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Read more »

Study Design

Related Conditions & MeSH terms

Intervention

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)

Locations
Country Name City State
Belgium CHU Brugmann Brussels
Belgium CHU Saint-Pierre Brussels
Belgium Hôpital Erasme Brussels
Belgium Hôpitaux Iris Sud Brussels
Belgium Jules Institute Bordet Brussels

Sponsors (6)
Lead Sponsor Collaborator
Serge Rozenberg Centre Hospitalier Universitaire Brugmann, Erasme University Hospital, Hôpitaux IRIS Sud, Jules Bordet Institute, NOVAVISION GROUP S.P.A

Country where clinical trial is conducted

Belgium, 

References & Publications (16)

See more »

Outcome
Type Measure Description Time frame Safety issue
Primary Change from baseline to week 12 (+4 weeks) of self-assessment of the most bothersome symptom dyspareunia, evaluated by a questionnaire 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
Primary Change from baseline to week 12 (+4 weeks) of vaginal cell maturation (Maturation Index). 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
Primary Change from baseline to week 12 (+4 weeks) of vaginal pH 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 Change from baseline to week 12 (+4 weeks) of the "Vaginal Health Index" (VHI) 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
Secondary Change from baseline to week 12 (+4 weeks) of the vulvovaginal symptoms 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
Secondary Change from baseline to week 12 (+4 weeks) in the two groups of the "Female Sexual Function Index (FSFI) 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
See also
  Status Clinical Trial Phase
Recruiting NCT05812924 - A Novel Therapy for Breast Cancer Survivors With Genitourinary Syndrome of Menopause Phase 2
Completed NCT04535323 - Platelet Rich Plasma for the Treatment of Genitourinary Syndrome of Menopause in Patients With Stage 0-III Breast Cancer Phase 1
Completed NCT03331328 - MonaLisa Touch Randomized Double-Blind Placebo Controlled Study N/A
Recruiting NCT04746456 - Vulvovaginal Atrophy Questionnaire (VVAQ): Psychometric Validation of a Novel PROM
Withdrawn NCT04606550 - MonaLisa Laser Intervention for Post-Menopausal Breast Cancer Patients: A SHE CAN Study N/A
Completed NCT04705883 - Vaginal Prasterone In Vaginal Atrophy In Breast Cancer Survivors Phase 4
Recruiting NCT05953090 - VALOR: Vaginal Atrophy & Long-term Observation of Recovery N/A
Active, not recruiting NCT04619485 - Sexual and Vaginal Health in Breast Cancer Women Receiving Aromatase Inhibitors Before and After CO2 Laser Therapy N/A
Completed NCT04607798 - Multi-polar RF and PEMF for Treatment of Vulvovaginal Atrophy N/A
Recruiting NCT06124820 - RCT Comparing Intravaginal Laser Therapy to Sham in Post-menopausal Women With Recurrent Urinary Tract Infections N/A
Completed NCT05561972 - The Ultrasonographic Assessment of Efficacy of Injectable Hyaluronic Acid for Genitourinary Syndrome of Menopause N/A
Recruiting NCT05571527 - Comparison of Vaginal Hyaluronic Acid Treatment Over Autologous Platelet Rich Plasma Treatment for Genitourinary Syndrome of Menopause N/A
Recruiting NCT04677491 - Effects of Ospemifene on Brain Activation Patterns in Women With Sexual Interest-arousal Disorders Phase 4
Not yet recruiting NCT06425978 - Efficacy of the Use of Cellular Matrix/ A-CP-HA Kit Phase 4
Recruiting NCT05672901 - Silicone Gel vs. Estrogen Vaginal Cream for the Management of Genitourinary Syndrome of Menopause N/A
Recruiting NCT03782480 - Examining Effects of Intrarosa in Women With Genitourinary Syndrome of Menopause/Vulvovaginal Atrophy Phase 3
Recruiting NCT06028009 - PRP Injections for Genitourinary Syndrome of Menopause N/A
Not yet recruiting NCT06007027 - Vaginal CO2 Laser Therapy for Genitourinary Syndrome in Breast Cancer Survivors N/A
Completed NCT05782920 - Management of Cancer Therapy Related Vulvovaginal Atrophy N/A
Completed NCT05464654 - Vaginal Biorevitalization With Polydeoxyribonucleotides for the Improvement of the Genitourinary Syndrome of Menopause N/A