Clinical trial NCT03857893: New Non-Hormonal Treatment by Radiofrequency for Vulvo-Vaginal Atrophy
Official title: Thermal Treatment of Vulvo-vaginal Atrophy (VVA) Using Novel Low-energy Dynamic Quadripolar Radio-Frequency (DQRF)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Vulvo-vaginal Atrophy
Genitourinary Syndrome of Menopause
Keywords: Vulvo-vaginal atrophy
Dynamic Quadripolar Radio-Frequency
Menopause
Genitourinary syndrome of menopause
Lead sponsor: Centre Hospitalier Universitaire Saint Pierre
Sponsor class: OTHER
Collaborators: name: NOVAVISION GROUP S.P.A
name: Jules Bordet Institute
name: Erasme University Hospital
name: Centre Hospitalier Universitaire Brugmann
name: Hôpitaux IRIS Sud
First posted: 2019-02-28
Enrollment: 53
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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:

  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

Primary outcomes:
measure: Change from baseline to week 12 (+4 weeks) of self-assessment of the most bothersome symptom dyspareunia, evaluated by a questionnaire
timeFrame: Up to 12 (+4 weeks) week after beginning of treatment
measure: Change from baseline to week 12 (+4 weeks) of vaginal cell maturation (Maturation Index).
timeFrame: Up to 12 (+4 weeks) week after beginning of treatment
measure: Change from baseline to week 12 (+4 weeks) of vaginal pH
timeFrame: Up to 12 (+4 weeks) week after beginning of treatment
Secondary outcomes:
measure: Change from baseline to week 12 (+4 weeks) of the "Vaginal Health Index" (VHI)
timeFrame: Up to 12 (+4 weeks) week after beginning of treatment
measure: Change from baseline to week 12 (+4 weeks) of the vulvovaginal symptoms
timeFrame: Up to 12 (+4 weeks) week after beginning of treatment
measure: Change from baseline to week 12 (+4 weeks) in the two groups of the "Female Sexual Function Index (FSFI)
timeFrame: Up to 12 (+4 weeks) week after beginning of treatment
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CHU Brugmann
city: Brussels
country: Belgium
facility: CHU Saint-Pierre
city: Brussels
country: Belgium
facility: Hôpital Erasme
city: Brussels
country: Belgium
facility: Hôpitaux Iris Sud
city: Brussels
country: Belgium
facility: Jules Institute Bordet
Study officials:
affiliation: Centre Hospitalier Universitaire Saint Pierre
name: Serge Rozenberg, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
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