Botox on Vulvar Vestibulitis

Vulvar Vestibulitis Clinical Trial

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Vulvar Diseases
• Vulvar Vestibulitis

• NCT number: NCT00119886
• Study type: Interventional
• Source: Rigshospitalet, Denmark
• Contact: Christina Damsted Petersen
• Phone: +45 35 45 74 11
• Email: rh19386@rh.dk
• Status: Recruiting
• Phase: Phase 4
• Start date: April 2005
• Completion date: June 2008