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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum toxin | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Reduce vulvar pain on a visual analogue scale (VAS). |
| Measure | Description | Time Frame |
|---|---|---|
| Investigate the effect on sexuality, quality of life, marital relationship, depression and need of analgesics |
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Inclusion Criteria:
Exclusion Criteria:
Treated earlier with Botulinum toxin
Ongoing vulvar infection
Age<18
Skin disease
Pregnancy
Myasthenia gravis
Amyotrophic lateral sclerosis (ALS)
Diabetes
Using:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christina Damsted Petersen | Contact | +45 35 45 74 11 | 85 89 | rh19386@rh.dk |
| Lene Lundvall | Contact | +35 45 35 45 | 50 31 |
| Name | Affiliation | Role |
|---|---|---|
| Christina Damsted Petersen, MD | Rigshospitalet, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet | Recruiting | Copenhagen | 2100 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15162347 | Result | Gunter J, Brewer A, Tawfik O. Botulinum toxin a for vulvodynia: a case report. J Pain. 2004 May;5(4):238-40. doi: 10.1016/j.jpain.2004.02.575. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D054515 | Vulvar Vestibulitis |
| D014845 | Vulvar Diseases |
| ID | Term |
|---|---|
| D014847 | Vulvitis |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| ID | Term |
|---|---|
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
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| Rigshospitalet | Recruiting | Copenhagen | 2100 | Denmark |
|
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D004798 |
| Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |