Infiltration of the Vestibulum Vaginae With Botulin Toxin in Patients With Localized Provoked Vulvodynia (VVS-01)
Primary Purpose
Localized Provoked Vulvodynia
Status
Completed
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
Botulin toxin
physiological water
Sponsored by
About this trial
This is an interventional treatment trial for Localized Provoked Vulvodynia
Eligibility Criteria
Inclusion Criteria:
- +18 years, of sound mind
- Dutch speaking
- Previously treated for this condition with neuropathic pain medication (antidepressants and anti-epileptics)
- in good health
Exclusion Criteria:
- systemic diseases
- pregnancy
Sites / Locations
- University Hospital Ghent
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
botulin toxin
physiological water
Arm Description
botulin toxin
physiological water
Outcomes
Primary Outcome Measures
to evaluate the efficacy and safety of botulin toxin in alleviating dyspareunia associated with localized provoked vulvodynia.
Before each session (every 6 weeks) and after the last session the patients will have to fill in a FSFI questionnaire. This way we can evaluate the influence of the therapy on the patients' sexual wellbeing. (efficacy)
Before each sessions and 6 weeks after the last injection, patients will undergo Q-tip testing. This way we can objectively evaluate the pain score over the vestibulum. (efficacy)
Recording of self-reported side-effects
Secondary Outcome Measures
Full Information
NCT ID
NCT01747161
First Posted
December 5, 2012
Last Updated
June 21, 2018
Sponsor
University Hospital, Ghent
1. Study Identification
Unique Protocol Identification Number
NCT01747161
Brief Title
Infiltration of the Vestibulum Vaginae With Botulin Toxin in Patients With Localized Provoked Vulvodynia
Acronym
VVS-01
Official Title
Randomized Placebo Controlled Double Blind Study: Efficacy and Safety of Infiltration of the Vestibulum Vaginae With Botulin Toxin in Patients With Localized Provoked Vulvodynia.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
December 17, 2013 (Actual)
Primary Completion Date
November 13, 2014 (Actual)
Study Completion Date
June 19, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
In this study we will investigate the efficacy and safety of infiltration of the vestibulum vaginae with botulin toxin in women who were diagnosed with localized provoked vulvodynia. In literature covering this subject we find that the prevalence of this condition is between 10 and 15%. Especially young, sexually active women suffer from this problem and some of them are not capable of having sexual relations with their partner because of this burning pain.
The most probable explanation for the physiopathological mechanism is an increase of nerve endings in the epithelium of the vestibulum, with an increase and activation of pain receptors in the vestibular mucosa. It also seems that patients with vestibulodynia have a higher tonus of the pelvic floor muscles, a greater muscle contraction in response to pain and a lower capacity of relaxation.
Botulin toxin (Botox) is a neurotoxin that causes a temporary paralysis of the muscle cells. That way it can decrease the increased tension of the pelvic floor muscles Botox also inhibits the pain receptors in the vestibulum.
Patients will be recruited through the gynecology consultations. Every patient with localized provoked vulvodynia that has tried previous treatments (pelvic floor muscle therapy, antidepressants, anti-epileptics, local anesthetics) will undergo Q-tip testing. If positive and there are no underlying diseases, the patient will be invited to participate in the study and after oral and written informed consent, will be included in the study population. Every 6 weeks there will be given injections with 50 units of botulin toxin, on 6 different spots in the vestibulum. 50 % of the subjects will receive physiological water instead of Botox (control population). After 3 sessions, we will assess if there is any difference in provoked pain in treated patients vs. placebos through Q-tip testing.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Localized Provoked Vulvodynia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
botulin toxin
Arm Type
Experimental
Arm Description
botulin toxin
Arm Title
physiological water
Arm Type
Placebo Comparator
Arm Description
physiological water
Intervention Type
Drug
Intervention Name(s)
Botulin toxin
Intervention Description
50 I.E. Botulin toxin. Injections in 6 spots of the vestibulum vaginae (3 sessions (every 6 weeks))
Intervention Type
Drug
Intervention Name(s)
physiological water
Intervention Description
3 mL physiological water. Injections in 6 spots of the vestibulum vaginae (3 sessions (every 6 weeks))
Primary Outcome Measure Information:
Title
to evaluate the efficacy and safety of botulin toxin in alleviating dyspareunia associated with localized provoked vulvodynia.
Description
Before each session (every 6 weeks) and after the last session the patients will have to fill in a FSFI questionnaire. This way we can evaluate the influence of the therapy on the patients' sexual wellbeing. (efficacy)
Before each sessions and 6 weeks after the last injection, patients will undergo Q-tip testing. This way we can objectively evaluate the pain score over the vestibulum. (efficacy)
Recording of self-reported side-effects
Time Frame
every 6 weeks up to week 18
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
+18 years, of sound mind
Dutch speaking
Previously treated for this condition with neuropathic pain medication (antidepressants and anti-epileptics)
in good health
Exclusion Criteria:
systemic diseases
pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Weyers, Md, PhD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Hans Verstraelen, MD, PhD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
12. IPD Sharing Statement
Links:
URL
http://www.uzgent.be
Description
Website University Hospital Ghent
Learn more about this trial
Infiltration of the Vestibulum Vaginae With Botulin Toxin in Patients With Localized Provoked Vulvodynia
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