Botulinum Toxin A as a Treatment for Provoked Vestibulodynia
Vulvodynia
About this trial
This is an interventional treatment trial for Vulvodynia focused on measuring botulinum toxin A, treatment
Eligibility Criteria
Inclusion Criteria:
- Age 18-40 years
- PVD defined as significant pain at vestibular contact and vaginal entry
- VAS ≥ 6 at the tampon test or severe pain, preventing intercourse
- Duration of symptoms of ≥ 3 months
- 0-para
- Patients who are willing to participate in the study after it has been explained orally and in writing will be included.
Exclusion Criteria:
- Vulvo-vaginal infection
- Dermatological conditions or other causes to dyspareunia
- Regular medication with analgesics
- Major psychiatric or medical disease
- Known allergy to any components of the active drug (Botox®)
- Medical disease contradictory to treatment with the active drug (Botox®)
- Peripheral motor neurological disease such as myasthenia gravis, amyotrophic lateral sclerosis or Lambert-Eaton syndrome
- Diabetes)
- Pregnancy
- Pelvic floor deficiency with urine and or flatulence incontinence.
Sites / Locations
- Danderyd Hospital, Dep. of Obstetrics and Gynecology
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
Placebo Comparator
Botulinum toxin A vs placebo
Botulinum toxin A
NaCl
50 Allergan units (diluted in 0,5 ml sterile NaCl) or 0,5 ml of sterile NaCl will be injected in the bulbocavernosus muscle just inside the hymenal ring. The injection with the same substance, dose and volume will be repeated after 3 months.
50 Allergan units (diluted in 0,5 ml sterile NaCl) will be injected in the bulbocavernosus muscle just inside the hymenal ring. The injection with the same substance, dose and volume will be repeated after 3 months.
0,5 ml of sterile NaCl will be injected in the bulbocavernosus muscle just inside the hymenal ring. The injection with the same substance and volume will be repeated after 3 months.