Infiltration of the Vestibulum Vaginae With Botulin Toxin in Patients With Localized Provoked Vulvodynia (VVS-01)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2012 by University Hospital, Ghent
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01747161
First received: December 5, 2012
Last updated: December 10, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Localized Provoked Vulvodynia
Drug: Botulin toxin
Drug: physiological water
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • to evaluate the efficacy and safety of botulin toxin in alleviating dyspareunia associated with localized provoked vulvodynia. [ Time Frame: every 6 weeks up to week 18 ] [ Designated as safety issue: Yes ]

    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


Estimated Enrollment: 50
Study Start Date: January 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: botulin toxin
botulin toxin
Drug: Botulin toxin
50 I.E. Botulin toxin. Injections in 6 spots of the vestibulum vaginae (3 sessions (every 6 weeks))
Placebo Comparator: physiological water
physiological water
Drug: physiological water
3 mL physiological water. Injections in 6 spots of the vestibulum vaginae (3 sessions (every 6 weeks))

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01747161

Contacts
Contact: Steven Weyers, MD, PhD Steven.weyers@ugent.be

Locations
Belgium
University Hospital Ghent Not yet recruiting
Ghent, Belgium, 9000
Principal Investigator: Steven Weyers, MD, PhD         
Principal Investigator: Hans Verstaelen, MD, PhD         
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Study Director: Steven Weyers, Md, PhD University Hospital, Ghent
Principal Investigator: Hans Verstraelen, MD, PhD University Hospital, Ghent
  More Information

Additional Information:
No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01747161     History of Changes
Other Study ID Numbers: 2012/445
Study First Received: December 5, 2012
Last Updated: December 10, 2012
Health Authority: Belgium: Ethics Committee
Belgium: Federal Agency for Medicinal Products and Health Products

Additional relevant MeSH terms:
Vulvodynia
Vulvar Diseases
Genital Diseases, Female
Botulinum Toxins
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014