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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
64
Rigshospitalet
Copenhagen, Denmark
RECRUITINGRigshospitalet
Copenhagen, Denmark
RECRUITINGReduce vulvar pain on a visual analogue scale (VAS).
Investigate the effect on sexuality, quality of life, marital relationship, depression and need of analgesics
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