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

August 3, 2016 updated by: Centre Hospitalier Universitaire de Besancon
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

21

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Besançon, France, 25000
        • CHU Besançon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patients suffering from provoked vestibulodynia, monitored in the Dermatology Department of the University Hospital of Besançon

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Long-term pain improvement after botulinum toxin injections
Time Frame: 18 months
Assessment and comparison of pain using Visual Analogic Scale values before treatment,3 months after treatment and 18 months after treatment.
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besancon

Investigators

  • Principal Investigator: Fabien Pelletier, MD, CHU Besançon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

August 1, 2016

First Submitted That Met QC Criteria

August 3, 2016

First Posted (Estimate)

August 8, 2016

Study Record Updates

Last Update Posted (Estimate)

August 8, 2016

Last Update Submitted That Met QC Criteria

August 3, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P/2013/175

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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