Vestibulodynia
Conditions
Keywords
capsaicin, pain improvement, provoked vulvodynia
Brief summary
This study aims to assess the pain on contact in provoked vestibulodynia, measured with Visual Analogic Scale at week 0/week 2/week 6/week 12 after applying a patch of capsaicin.
Interventions
DRUGCapsaicin patch
After a pre-medication with paracetamol, patches are applied and removed after 20 minutes. Patients remain under observation for 2 hours after removal.
Sponsors
Centre Hospitalier Universitaire de Besancon
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Provoked vulvodynia, rated B2a according to 2003 International Society for the Study of Vulvovaginal Disease (ISSVD) classification * Pain ≥ 4 on Visual Analogic Scale (VAS) * Subject refractory to at least 2 conventional treatments (tricyclic antidepressants, anticonvulsants at analgesic doses , biofeedback physical therapy, psychological assessment in a context of chronic pain) or to botulinum toxin A * If a former treatment with botulinum toxin A was performed: patient must be in treatment failure (= no decrease over 50% of the pain 3 months after initiation of the treatment) * Negative screening test results * Menopause, surgically sterilized women or women using effective contraceptive method * Good understanding and predictable adherence to the protocol * Beneficiary/affiliated to French social security/social healthcare * Signed Informed Consent Form
Exclusion criteria
* Predictable poor adherence * Pregnant or breastfeeding women * Diabetes mellitus type 1 or type 2 * Major mental disorders * Underlying etiology such as chronic vulvar disease * Initial vulvar erythema * Vulnerable subjects (particularly adults under guardianship) * Ongoing medical treatment with tricyclic antidepressants or anticonvulsants at analgesic doses Subject refractory to conventional treatments (tricyclic antidepressants and benzodiazepines doses analgesics, physiotherapy type of biofeedback) Good understanding and predictable adherence to the protocol beneficiary/affiliated to French social security/social healthcare signed Informed Consent Form
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain assessment with Visual Analogic Scale (using a q-tip) | week 12 | Assessment of provoked pain with Visual Analogic Scale (using a q-tip) |
Countries
France
Outcome results
None listed