Infiltration of the Vestibulum Vaginae With Botulin Toxin in Patients With Localized Provoked Vulvodynia (VVS-01)
Recruitment status was: Recruiting
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.
|Localized Provoked Vulvodynia||Drug: Botulin toxin Drug: physiological water||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, 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.|
- 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 ]
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
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||June 2016|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Experimental: 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
Drug: physiological water
3 mL physiological water. Injections in 6 spots of the vestibulum vaginae (3 sessions (every 6 weeks))
Please refer to this study by its ClinicalTrials.gov identifier: NCT01747161
|Contact: Steven Weyers, MD, PhD||Steven.firstname.lastname@example.org|
|University Hospital Ghent||Recruiting|
|Ghent, Belgium, 9000|
|Principal Investigator: Steven Weyers, MD, PhD|
|Principal Investigator: Hans Verstaelen, MD, PhD|
|Study Director:||Steven Weyers, Md, PhD||University Hospital, Ghent|
|Principal Investigator:||Hans Verstraelen, MD, PhD||University Hospital, Ghent|