Vulvar Diseases, Vulvar Vestibulitis
Conditions
Brief summary
The study seeks to evaluate the effect of botulinum toxin on vulvar vestibulitis (VVS) after local injection with Botox, a potential treatment to relieve patients of vulvar pain, reducing the need for painkillers, and improving the sexual quality of life of the patients.
Detailed description
Vulvar vestibulitis (VVS) is characterized by pain confined to the vulvar vestibule that occurs upon touch and attempted introitus entry ( e.g. intercourse, tampon insertion), with minimal associated clinical findings. The aetiology of VVS is not well established and many variables have been associated with the condition, e.g. neuropathy secondary to inflammation. Injection of Botulinum Toxin is tested as a therapeutic option for this condition. A temporary paralytic effect on the surrounding skeletal muscle hypertonicity is seen and earlier in cases described as a successful treatment of pelvic floor dysfunction, dyspareunia and interstitial cystitis.
Interventions
DRUGBotulinum toxin
Sponsors
Rigshospitalet, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Vulvar vestibulitis * Safe birth control
Exclusion criteria
* Treated earlier with Botulinum toxin * Ongoing vulvar infection * Age\<18 * Skin disease * Pregnancy * Myasthenia gravis * Amyotrophic lateral sclerosis (ALS) * Diabetes * Using: * Calcium antagonists; * Aminoglycosides; * Magnesium sulfate; * Systemic steroid treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduce vulvar pain on a visual analogue scale (VAS). | — |
Secondary
| Measure | Time frame |
|---|---|
| Investigate the effect on sexuality, quality of life, marital relationship, depression and need of analgesics | — |
Countries
Denmark
Contacts
Primary ContactChristina Damsted Petersen
Backup ContactLene Lundvall
Outcome results
None listed