A Pilot Study of the Effects of Botulinum Toxin in the Treatment of Provoked Vestibulodynia

Study Overview
=================
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.

Conditions
-----------------
Vestibulodynia

Intervention / Treatment
-----------------
* Drug: Botulinum Toxin Type A
* Other: Saline solution
* Other: Indexes


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Botulinum toxin<br>Injection of 50 units (50U) botulinum toxin type A (powder), reconstituted in 1 mL physiologic saline solution in each perineal muscle (100 units in total). First injection at day 1 and. A second injection is scheduled at 3 months, only if there is a 50% or more pain improvement compared to baseline (pain measured with Visual Analogic Scale). | Drug: Botulinum Toxin Type A<br> <br> Other: Indexes<br>* Visual Analogic Scale (VAS), Female Sexual Function Index (FSFI), Dermatology Life Quality Index (DLQI)<br>|
| Placebo Comparator: Saline solution<br>Injection of 1 mL physiologic saline solution in each perineal muscle. A second injection is scheduled at 3 months, only if there is a 50% or more pain improvement compared to baseline (pain measured with Visual Analogic Scale). | Other: Saline solution<br> <br> Other: Indexes<br>* Visual Analogic Scale (VAS), Female Sexual Function Index (FSFI), Dermatology Life Quality Index (DLQI)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain improvement | Significant improvement of pain on contact in the treated group, compared to placebo group, measured with Visual Analogic Scale | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Botulinum toxin, Pain improvement