Botulinum Toxin A as a Treatment for Provoked Vestibulodynia

• Status: Completed
• Trial end date: 2019-06-15
• Target enrollment: 0
• Participant gender: Female

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 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.

Objectives and outcome Women with PVD will be recruited for a double blind RCT of 2 injection of 50 Allergan-units BTA (3 months apart) or placebo in the bulbocavernous muscles (situated adjacent to the lower part of the vagina).

Primary outcome: The reduction of patient self-reported dyspareunia measured by VAS 0 (no pain) to 100 (worst pain imaginable).

Secondary outcome: Pain at tampon insertion measured by VAS 0-100, functional measurement of dyspareunia (see below), the reduction of pelvic floor hyperactivity/tonus, measured with a vaginal manometer, safety aspects and effect duration of BTA, influence on quality of life and psychosexual evaluation.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

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.