Trial | NCT03857893  Report issue

Title

New Non-Hormonal Treatment by Radiofrequency for Vulvo-Vaginal Atrophy
Thermal Treatment of Vulvo-vaginal Atrophy (VVA) Using Novel Low-energy Dynamic Quadripolar Radio-Frequency (DQRF)

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Terminated

  • Intervention/Treatment

    pH-Cream ...

  • Study Participants

    53
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 Started
Mar 01
2019
Primary Completion
Dec 08
2021
Study Completion
Dec 08
2021
Last Update
Mar 24
2022

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

Control Group : pH-Cream Active Comparator

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).

Dynamic Quadripolar Radio-Frequency treatment Experimental

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.

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
No Results Posted