Botox on Vulvar Vestibulitis

Vulvar Vestibulitis Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00119886
• Other study ID #: Bosex
• Status: Recruiting
• Phase: Phase 4
• First received: July 6, 2005
• Last updated: April 18, 2007
• Start date: April 2005
• Est. completion date: June 2008

Study information

• Verified date: April 2007
• Source: Rigshospitalet, Denmark
• Contact: Christina Damsted Petersen
• Phone: +45 35 45 74 11
• Email: rh19386[@]rh.dk
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

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

Intervention

Drug:
• Botulinum toxin

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen
Denmark	Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

Gunter J, Brewer A, Tawfik O. Botulinum toxin a for vulvodynia: a case report. J Pain. 2004 May;5(4):238-40. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduce vulvar pain on a visual analogue scale (VAS).
Secondary	Investigate the effect on sexuality, quality of life, marital relationship, depression and need of analgesics

External Links

•   Link