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

Serge Rozenberg

Status: Terminated

Conditions: Vulvo-vaginal Atrophy; Genitourinary Syndrome of Menopause

Treatments: Device: Dynamic Quadripolar Radio-Frequency treatment; Drug: pH-Cream

Study type: Interventional

Funder types: Other

Identifiers

NCT03857893

B076201938646

Details and patient eligibility

About

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.

Enrollment: 53 patients

Sex: Female

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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53 participants in 2 patient groups

Control Group : pH-Cream

Active Comparator group

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).

Treatment:

Drug: pH-Cream

Dynamic Quadripolar Radio-Frequency treatment

Experimental group

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.

Treatment:

Device: Dynamic Quadripolar Radio-Frequency treatment

Drug: pH-Cream