Status:
COMPLETED
Botulinum Toxin A as a Treatment for Provoked Vestibulodynia
Lead Sponsor:
Karolinska Institutet
Conditions:
Vulvodynia
Eligibility:
FEMALE
18-40 years
Phase:
PHASE3
Brief Summary
Women with provoked vestibulodynia (PVD) suffer from severe dyspareuni and often present a hyperactivity of the pelvic floor muscles (PFM) which maintain the dyspareunia. The rationale for the study i...
Detailed Description
Rationale Dyspareunia is a common pain problem among women. The prevalence has been estimated to be 10-15%. The most common type of dyspareunia among premenopausal women is provoked vestibulodynia (PV...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 15 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 15 2019
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT04057755
Start Date
May 15 2016
End Date
June 15 2019
Last Update
August 15 2019
Active Locations (1)
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1
Danderyd Hospital, Dep. of Obstetrics and Gynecology
Stockholm, Sweden, 182 88