Localized provoked vulvodynia at the vestibule, known as vestibulodynia (VBD) Urological and Genital Diseases
Conditions
Interventions
This is a case-control study in women with vestibulodynia (VBD). All women aged 18 years and before menopause, (cessation of menstruation for 12 months) with VBD that will present to our unit on lower
Sponsors
Associazione Italiana Vulvodinia Onlus
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women aged at least 18 years old and before menopause (absence of menstruation for 12 months) 2. Experience moderate to severe pain (minimum of 5/10 on a numerical rating scale in at least 90 % of attempted sexual intercourse) for the VBD group 3. Pain limited to the vestibule during vaginal intercourse and during activities exerting pressure on the vestibule (tampon insertion, tight jeans or pants, cycling, horseback riding) for VBD group 3. Presence of VBD for at least 3 months and diagnosed according to the standardized gynecological examination protocol by one of our staff gynecologists 4. Have a stable sexual partner (sexual activity should include some attempted vaginal penetrations to evaluate pain intensity) 5. Subject is willing to attempt sexual activity between visits 6. Read and signed informed consent
Exclusion criteria
Exclusion criteria: 1. Active vulvovaginal infections at the time of their gynecological examination 2. Genital bleeding of unknown origin 3. Unwillingness to provide informed consent to the trial 4. Women with concomitant vulvar dermatosis or other vulvar disorders 5. Symptoms or signs in the past related to VBD, only for the Control group
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. DNA patterns obtained from a blood sample measured using Shallow Genome Sequencing at baseline 2. Vestibular microbiome asset obtained from a vestibular sample measured using complex analysis using 16sRNA technique at baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Vulvar vestibule current perception threshold (CPT) values (1=0.01 mA) measured using a G-trode Vaginal/Rectal Electrode (Neurotron, Inc., Baltimore, MD) at baseline 2. Vestibular mucosa thickness measured using ultrasound measurements (B-Scan) with a 20 MHz validated system (Derma Scan C, Cortex Technology, Denmark), producing cross-sectional images of the skin down to a depth of approximately 15 mm at baseline 3. Vaginal electromyography (EMG) measured at rest and during several exercises of the pelvic floor using an EMG device with a vaginal sensor (Myotonus plus©-London-UK) at baseline | — |
Countries
Italy
Outcome results
None listed