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

Centre Hospitalier Universitaire de Besancon

Status and phase: Completed; Phase 3

Conditions: Vestibulodynia

Treatments: Other: Indexes; Other: Saline solution; Drug: Botulinum Toxin Type A

Study type: Interventional

Funder types: Other

Identifiers

NCT02858219

API/2011/20

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Botulinum toxin

Experimental group

Description:

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).

Treatment:

Other: Indexes

Drug: Botulinum Toxin Type A

Saline solution

Placebo Comparator group

Description:

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).

Treatment:

Other: Indexes

Other: Saline solution