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

Sponsor
Centre Hospitalier Universitaire de Besancon (Other)
Overall Status
Completed
CT.gov ID
NCT02858375
Collaborator
(none)
21
Enrollment
1
Location
1
Duration (Months)
20.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    21 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Study Start Date :
    Mar 1, 2013
    Actual Primary Completion Date :
    Apr 1, 2013
    Actual Study Completion Date :
    Apr 1, 2013

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHU Besançon Besançon France 25000

    Sponsors and Collaborators

    • Centre Hospitalier Universitaire de Besancon

    Investigators

    • Principal Investigator: Fabien Pelletier, MD, CHU Besançon

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre Hospitalier Universitaire de Besancon
    ClinicalTrials.gov Identifier:
    NCT02858375
    Other Study ID Numbers:
    • P/2013/175
    First Posted:
    Aug 8, 2016
    Last Update Posted:
    Aug 8, 2016
    Last Verified:
    Aug 1, 2016
    Keywords provided by Centre Hospitalier Universitaire de Besancon
    quality of life
    botulinum toxin
    provoked vulvodynia
    Additional relevant MeSH terms:
    Vulvodynia
    Vulvar Vestibulitis

    Study Results

    No Results Posted as of Aug 8, 2016