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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02858375

Acronym

QUALVESTO

Enrollment

Registered

2016-08-08

Start date

2013-03-31

Completion date

2013-04-30

Last updated

2016-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vestibulodynia

Keywords

quality of life, botulinum toxin, provoked vulvodynia

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 60 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

France

Outcome results