Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00119886
Status:
UNKNOWN
Last Update Posted:
2007-04-19
First Post:
2005-07-06
Brief Title:
Botox on Vulvar Vestibulitis
Sponsor:
Rigshospitalet Denmark
Organization:
Rigshospitalet Denmark
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2007-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 eg 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 eg 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
The aetiology of VVS is not well established and many variables have been associated with the condition eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None