Long-Term Assessment of Quality of Life and Effectiveness of Onabotulinumtoxina Injections in Provoked Vestibulodynia

Completed

• Conditions: Vestibulodynia

• Registration Number: NCT02858375
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

Brief Summary

The study aims to assess and compare the pain in women suffering from provoked vestibulodynia, before treatment with botulinum injections, 3 months after treatment and 18 months after treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2016-08
• Study First Submitted: 2016-08-01
• Study First Submitted QC: 2016-08-03
• Last Update Submitted: 2016-08-03
• Study First Posted: 2016-08-08
• Last Update Posted: 2016-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 21

Inclusion Criteria

• Vestibulodynia rated B2 according to 2003 International Society for the Study of Vulvovaginal Disease (ISSVD) classification
• Patients previously treated no later than18 months ago for provoked vestibulodynia with botulinum toxin injections, in the University Hospital of Besançon.

Exclusion Criteria

• Major psychologic disorders.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Long-term pain improvement after botulinum toxin injections	18 months	Assessment and comparison of pain using Visual Analogic Scale values before treatment,3 months after treatment and 18 months after treatment.

Trial Locations

Locations (1)

CHU Besançon; 🇫🇷 Besançon, France