A Trial of Pelvic Floor Chemodenervation in Patients Undergoing Physical Therapy for High Tone Pelvic Floor Dysfunction

High-tone pelvic floor dysfunction is often a painful condition that can be associated with a
number of female pelvic syndromes including childhood elimination disorders, idiopathic
urinary retention, vaginismus, dyspareunia, pelvic pain, constipation, sport injuries,
postoperative and bladder pain syndrome/interstitial cystitis. Following appropriate patient
education about pelvic floor function, mainstays of therapy for high-tone pelvic floor
dysfunction pelvic pain include pharmacotherapeutic agents and pelvic floor physical therapy.
The investigators hypothesize that chemodenervation with Botulinum toxin A will offer a safe,
efficacious intervention for women with high tone pelvic floor dysfunction that cannot be
adequately treated with pelvic floor physical therapy alone.

Inclusion Criteria:

- Age 18 years or older

- >6 month history of pelvic pain or dyspareunia with high tone pelvic floor dysfunction
on exam (pain with palpation of superficial transverse perineii, bulbocavernosus
insertion to perineal/central tendon and/or levator ani complex/iliococcygeus)

- Women with male sexual partners

- History of undergoing pelvic floor physical therapy with internal manipulation
including trigger point release as directed, with inability to meet goals of therapy
despite appropriate pelvic floor physical therapy approach

- Able to read, write, and comprehend English sufficiently to offer informed consent

Exclusion Criteria:

- Presence of intact hymen, preventing internal manipulation during pelvic floor
physical therapy

- Pregnancy at the time of injection

- Breast feeding at the time of injection

- History of Myasthenia Gravis, Amyotrophic Lateral Sclerosis, Lambert-Eaton syndrome,
allergy to Botulinum toxin A, or other contraindication to Botulinum toxin A injection

- History of documented skin disorder of the vulva other than vaginal atrophy or lichen
planus

- Prior pelvic radiation

- Stage II-IV pelvic organ prolapse

- Has had a pelvic floor Botulinum toxin A injection within the last 12 weeks

- Unable to provide informed consent