Botox on Vulvar Vestibulitis

Rigshospitalet

Status and phase: Unknown; Phase 4

Conditions: Vulvar Diseases; Vulvar Vestibulitis

Treatments: Drug: Botulinum toxin

Study type: Interventional

Funder types: Other

Identifiers

NCT00119886

Bosex

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind