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

Serge Rozenberg53 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Vulvo-vaginal Atrophy Genitourinary Syndrome of Menopause

Interventions

Eligibility

Sex: FEMALEMin age: 40 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (5)

CHU Brugmann

Brussels, Belgium

CHU Saint-Pierre

Brussels, Belgium

Hôpital Erasme

Brussels, Belgium

Hôpitaux Iris Sud

Brussels, Belgium

Jules Institute Bordet

Brussels, Belgium

Outcomes

Primary Outcomes

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).