Botox on Vulvar Vestibulitis

Brief Title

Botox on Vulvar Vestibulitis


Brief 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.
    

Detailed 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 Phase

Phase 4

Study Type

Interventional


Primary Outcome

Reduce vulvar pain on a visual analogue scale (VAS).

Secondary Outcome

 Investigate the effect on sexuality, quality of life, marital relationship, depression and need of analgesics

Condition

Vulvar Vestibulitis

Intervention

Botulinum toxin


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

64

Start Date

April 2005

Completion Date

June 2008


Eligibility Criteria

        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
      

Gender

Female

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Christina Damsted Petersen, MD, +45 35 45 74 11, [email protected]

Location Countries

Denmark

Location Countries

Denmark

Administrative Informations


NCT ID

NCT00119886

Organization ID

Bosex



Study Sponsor

Rigshospitalet, Denmark


Study Sponsor

Christina Damsted Petersen, MD, Principal Investigator, Rigshospitalet, Denmark


Verification Date

April 2007