Botox on Vulvar Vestibulitis

• Sponsor: Rigshospitalet, Denmark (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00119886
• Collaborator: (none)
• Enrollment: 64
• Locations: 2
• Duration (Months): 38
• Patients Per Site: 32
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vulvar Vestibulitis; Vulvar Diseases	Drug: Botulinum toxin	Phase 4

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 Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Double
• Primary Purpose: Treatment
• Study Start Date: Apr 1, 2005
• Anticipated Study Completion Date: Jun 1, 2008

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

1. Investigate the effect on sexuality, quality of life, marital relationship, depression and need of analgesics []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rigshospitalet	Copenhagen		Denmark	2100
2	Rigshospitalet	Copenhagen		Denmark	2100

Sponsors and Collaborators

• Rigshospitalet, Denmark

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00119886
• Other Study ID Numbers: Bosex
• First Posted: Jul 14, 2005
• Last Update Posted: Apr 19, 2007
• Last Verified: Apr 1, 2007

• Additional relevant MeSH terms: Vulvar Vestibulitis; Vulvar Diseases; Botulinum Toxins

Study Results

No Results Posted as of Apr 19, 2007