Placebo-controlled RCT of Botulinum Toxin A as a Treatment for Provoked Vestibulodynia

• Status: Completed
• Trial end date: 2019-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

Women with provoked vestibulodynia (PVD) suffer from severe dyspareunia and often present a hyperactivity of the pelvic floor muscles (PFM) which maintain the dyspareunia. The rationale for the study is that for women with PVD who don't succeed to restore the function of the PFM by physiotherapy, Botulinum Toxin A (BTA) could be an optional treatment by decreasing the high muscle tonus and thus possibly reduce the coital pain.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Karolinska Institutet
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

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®) or 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 and diabetes),

• Pregnancy - a pregnancy test will be taken before both treatments (Visit 1 and 3), unless the participants are using highly effective birth control methods that can achieve a failure rate of less than 1% per year, when used consistently and correctly. Such methods include;

• combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal)

• progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable)

• intrauterine device (IUD)

• intrauterine hormone-releasing system (IUS)

• bilateral tubal occlusion

• sexual abstinence (if refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the preferred and usual lifestyle of the subject.

• Pelvic floor deficiency with urine and or flatulence incontinence.