Vulvodynia Urological and Genital Diseases
Conditions
Interventions
Randomization is determined by a computer-generated number list (MedCalc Version 20.110).
Active group: patients will receive one treatment cycle of transmucosal delivery of cannabidi
Sponsors
Ospedale dei Bambini Vittore Buzzi
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women at least 18 years of age and before the menopause 2. Experience moderate to severe pain (minimum of 5/10 on a numerical rating scale in at least 90 % of attempted sexual intercourse) 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) 4. Presence of VBD for at least 6 months and diagnosed according to the standardized gynecological examination protocol by a staff gynecologist 5. Have a stable sexual partner (sexual activity should include some attempted vaginal penetrations to evaluate pain intensity) 6. Subject is willing to attempt sexual activity between visits 7. 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. Patients concomitantly included in different interventional clinical trials 4. Unwillingness to provide informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Symptoms evaluated at baseline, 4 weeks and 8 weeks after treatment using: 1. 0-10 point visual scale (VAS) related to vulvar burning/pain and dyspareunia 2. Vestibular cotton swab test (small cotton-tipped applicator lightly rolled over the surfaces of the vestibule (mean of values at the 1, 3, 5, 6, 7, 9, and 11 o’clock locations by asking the subject to report pain intensity on a discrete visual analog scale of 1 (no pain) to 10 (worst possible pain). 3. Validated instruments: Female Sexual Function Index (FSFI), Vulvar Pain Functional Questionnaire (V-Q) | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of current perception threshold (CPT) testing (a technique which quantifies the sensitivity of vestibular nerve fibers) and vaginal EMG measurements, collected at states of rest and during several pelvic floor exercises through an EMG device with a vaginal sensor (Myotonus plus©-London-UK). The CPT values will be measured using the Neurometer CPT/C electrodiagnostic neurostimulator (Neurotron, Inc., Baltimore, MD), and vulvar vestibule CPT values will be determined using a G-trode Vaginal/ Rectal Electrode (Neurotron, Inc., Baltimore, MD). Measured at baseline, 4 weeks and 8 weeks follow-up visits. | — |
Countries
Italy
Outcome results
None listed