A Pilot Study of the Effects of Botulinum Toxin in the Treatment of Provoked Vestibulodynia
Overview
- Phase
- Phase 3
- Intervention
- Botulinum Toxin Type A
- Conditions
- Vestibulodynia
- Sponsor
- Centre Hospitalier Universitaire de Besancon
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Pain improvement
- Status
- Completed
- Last Updated
- 3 years ago
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.
Investigators
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
Arms & Interventions
Botulinum toxin
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).
Intervention: Botulinum Toxin Type A
Botulinum toxin
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).
Intervention: Indexes
Saline solution
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).
Intervention: Saline solution
Saline solution
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).
Intervention: Indexes
Outcomes
Primary Outcomes
Pain improvement
Time Frame: 3 months
Significant improvement of pain on contact in the treated group, compared to placebo group, measured with Visual Analogic Scale