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

• Status: Recruiting
• Trial end date: 2021-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Serge Rozenberg
• Collaborators: Centre Hospitalier Universitaire Brugmann; Erasme University Hospital; Hôpitaux IRIS Sud; Jules Bordet Institute; NOVAVISION GROUP S.P.A

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:

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