Vestibulodynia
Conditions
Keywords
Botulinum toxin, Pain improvement
Brief summary
The main objective of this study is to compare the efficacy of botulinum toxin injections on vestibulodynia pain compared to a group treated with a placebo.
Interventions
DRUGBotulinum Toxin Type A
OTHERSaline solution
OTHERIndexes
Visual Analogic Scale (VAS), Female Sexual Function Index (FSFI), Dermatology Life Quality Index (DLQI)
Sponsors
Centre Hospitalier Universitaire de Besancon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Subject refractory to conventional treatments (tricyclic antidepressants and benzodiazepines at analgesic doses, biofeedback physical therapy) * Negative screening test results * Notified associated factors * 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 * Myasthenia * Treatment with aminoglycosides * Major mental disorders * Underlying etiology * Vulnerable subjects (particularly adults under guardianship) * Any reason deemed relevant by the investigator * Current or former (in the last 3 months) participation to another clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain improvement | 3 months | Significant improvement of pain on contact in the treated group, compared to placebo group, measured with Visual Analogic Scale |
Countries
France
Outcome results
None listed