A Pilot Study of the Effects of Botulinum Toxin in the Treatment of Provoked Vestibulodynia
Phase 3
Completed
- Conditions
- Vestibulodynia
- Interventions
- Registration Number
- NCT02858219
- Lead Sponsor
- Centre Hospitalier Universitaire de Besancon
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 60
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Botulinum toxin Indexes 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). 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). Saline solution Indexes 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). Botulinum toxin Botulinum Toxin Type A 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).
- Primary Outcome Measures
Name Time Method Pain improvement 3 months Significant improvement of pain on contact in the treated group, compared to placebo group, measured with Visual Analogic Scale
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
CHU Besançon
🇫🇷Besançon, France
Hôpital Tenon
🇫🇷Paris, France