Botox on Vulvar Vestibulitis
Recruitment status was: Recruiting
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
- Reduce vulvar pain on a visual analogue scale (VAS).
- Investigate the effect on sexuality, quality of life, marital relationship, depression and need of analgesics
|Study Start Date:||April 2005|
|Estimated Study Completion Date:||June 2008|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00119886
|Copenhagen, Denmark, 2100|
|Principal Investigator:||Christina Damsted Petersen, MD||Rigshospitalet, Denmark|