Botulinum Toxin A as a Treatment for Provoked Vestibulodynia
Status:
Completed
Trial end date:
2019-06-15
Target enrollment:
Participant gender:
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
Details
Lead Sponsor:
Karolinska Institutet
Treatments:
abobotulinumtoxinA Botulinum Toxins Botulinum Toxins, Type A