Back to resultsNew Non-Hormonal Treatment by Radiofrequency for Vulvo-Vaginal Atrophy (ViViA)
Primary Purpose
Vulvo-vaginal Atrophy, Genitourinary Syndrome of Menopause
Status
Terminated
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Dynamic Quadripolar Radio-Frequency treatment
pH-Cream
Sponsored by
About this trial
This is an interventional treatment trial for Vulvo-vaginal Atrophy focused on measuring Vulvo-vaginal atrophy, Dynamic Quadripolar Radio-Frequency, Menopause, Genitourinary syndrome of menopause
Eligibility Criteria
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:
- Vaginal dryness (none, mild, moderate or severe),
- Vaginal and/or vulvar irritation/itching (none, mild, moderate or severe),
- Vaginal pain associated with sexual activity (none, mild, moderate or severe)
Postmenopausal women with VVA confirmed by at least one of the following criteria:
- A proportion of superficial cells ≤ 5% in the vaginal smear using a "Maturation Index"
- 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
Sites / Locations
- CHU Brugmann
- CHU Saint-Pierre
- Hôpital Erasme
- Hôpitaux Iris Sud
- Jules Institute Bordet
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control Group : pH-Cream
Dynamic Quadripolar Radio-Frequency treatment
Arm Description
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).
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.
Outcomes
Primary Outcome Measures
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).
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.
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)
Secondary Outcome Measures
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).
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).
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.
Full Information
NCT ID
NCT03857893
First Posted
February 26, 2019
Last Updated
March 9, 2022
Sponsor
Serge Rozenberg
Collaborators
NOVAVISION GROUP S.P.A, Jules Bordet Institute, Erasme University Hospital, Centre Hospitalier Universitaire Brugmann, Hôpitaux IRIS Sud
1. Study Identification
Unique Protocol Identification Number
NCT03857893
Brief Title
New Non-Hormonal Treatment by Radiofrequency for Vulvo-Vaginal Atrophy
Acronym
ViViA
Official Title
Thermal Treatment of Vulvo-vaginal Atrophy (VVA) Using Novel Low-energy Dynamic Quadripolar Radio-Frequency (DQRF)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Terminated
Why Stopped
The study was delayed due to the Covid 19 pandemic. The study was stopped prematurely due to a lack of efficiency (reported by the patients)
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
December 8, 2021 (Actual)
Study Completion Date
December 8, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Serge Rozenberg
Collaborators
NOVAVISION GROUP S.P.A, Jules Bordet Institute, Erasme University Hospital, Centre Hospitalier Universitaire Brugmann, Hôpitaux IRIS Sud
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vulvo-vaginal Atrophy, Genitourinary Syndrome of Menopause
Keywords
Vulvo-vaginal atrophy, Dynamic Quadripolar Radio-Frequency, Menopause, Genitourinary syndrome of menopause
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Group : pH-Cream
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Dynamic Quadripolar Radio-Frequency treatment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Dynamic Quadripolar Radio-Frequency treatment
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
pH-Cream
Other Intervention Name(s)
Cetomacrogol cream
Intervention Description
1g of Cetomacrogol cream (pH-cream) to self-administered with a vaginal applicator for 12 weeks (one dose every three days)
Primary Outcome Measure Information:
Title
Change from baseline to week 12 (+4 weeks) of self-assessment of the most bothersome symptom dyspareunia, evaluated by a questionnaire
Description
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).
Time Frame
Up to 12 (+4 weeks) week after beginning of treatment
Title
Change from baseline to week 12 (+4 weeks) of vaginal cell maturation (Maturation Index).
Description
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.
Time Frame
Up to 12 (+4 weeks) week after beginning of treatment
Title
Change from baseline to week 12 (+4 weeks) of vaginal pH
Description
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)
Time Frame
Up to 12 (+4 weeks) week after beginning of treatment
Secondary Outcome Measure Information:
Title
Change from baseline to week 12 (+4 weeks) of the "Vaginal Health Index" (VHI)
Description
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).
Time Frame
Up to 12 (+4 weeks) week after beginning of treatment
Title
Change from baseline to week 12 (+4 weeks) of the vulvovaginal symptoms
Description
The vulvovaginal symptoms will be evaluated by a 'vulvovaginal symptoms questionnaire" in postmenopausal women at baseline and week 12 (+4 weeks).
Time Frame
Up to 12 (+4 weeks) week after beginning of treatment
Title
Change from baseline to week 12 (+4 weeks) in the two groups of the "Female Sexual Function Index (FSFI)
Description
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.
Time Frame
Up to 12 (+4 weeks) week after beginning of treatment
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
Vaginal dryness (none, mild, moderate or severe),
Vaginal and/or vulvar irritation/itching (none, mild, moderate or severe),
Vaginal pain associated with sexual activity (none, mild, moderate or severe)
Postmenopausal women with VVA confirmed by at least one of the following criteria:
A proportion of superficial cells ≤ 5% in the vaginal smear using a "Maturation Index"
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Serge Rozenberg, MD,PhD
Organizational Affiliation
Centre Hospitalier Universitaire Saint Pierre
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Brugmann
City
Brussels
Country
Belgium
Facility Name
CHU Saint-Pierre
City
Brussels
Country
Belgium
Facility Name
Hôpital Erasme
City
Brussels
Country
Belgium
Facility Name
Hôpitaux Iris Sud
City
Brussels
Country
Belgium
Facility Name
Jules Institute Bordet
City
Brussels
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
10782451
Citation
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New Non-Hormonal Treatment by Radiofrequency for Vulvo-Vaginal Atrophy
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