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.

• Botulinum toxin A 50u (Drug), also known as BOTOX®, OnabotulinumtoxinA: Subject will receive injection of 50u Botulinum toxin A with local sedation as an office procedure.
• Botulinum toxin A 100u (Drug), also known as BOTOX®, OnabotulinumtoxinA: Subject will receive injection of 100u Botulinum toxin A in either the office or while anesthetized.
• Botulinum toxin A 150u (Drug), also known as BOTOX®, OnabotulinumtoxinA: Subject will receive injection of 150u Botulinum toxin A while anesthetized.

Primary outcomes

• Change in Visual Analog Pain Scale (Non-Menstrual Pelvic Pain) score [Baseline, Week 2, Month 3, Month 6, Month 9, Month 12]: This is a single question, "How severe is your pelvic pain at this time?"

Secondary outcomes

• Visual Analog Pain Scale (Dyspareunia) [Baseline, Week 2, Month 3, Month 6, Month 9, Month 12]: This is a single question, "How severe was your pelvic pain the last time you had sexual intercourse?"
• Patient Global Impression of Severity [Baseline, Week 2, Month 3, Month 6, Month 9, Month 12]: This questionnaire asks subjects to rate the severity of their pelvic pain symptoms. There are 4 choices to answer: 1 - Normal, no pain, 2 - Slightly more pain than normal, 3 - Significantly worse pain than normal, 4 - Severe pain.
• Pelvic Floor Distress Inventory Questionnaire [Baseline, Week 2, Month 3, Month 6, Month 9, Month 12]: Subjects' rating on this 20-item questionnaire will be based on their bowel, bladder, and pelvic symptoms.
• Female Sexual Function Index [Baseline, Week 2, Month 3, Month 6, Month 9, Month 12]: Subjects' rating on this 19-item questionnaire will be based on their sexual feelings and responses.
• Patient Global Impression of Improvement [Week 2, Month 3, Month 6, Month 9, Month 12]: This questionnaire asks subjects to rate their current pelvic pain symptoms compared to before treatment. There are 7 choices to answer: 1 - very much better compared to before treatment, 2 - somewhat better compared to before treatment, 3 - slightly better compared to before treatment, 4 - no change compared to before treatment, 5 - slightly worse compared to before treatment, 6 - somewhat worse compared to before treatment, 7 - very much worse compared to before treatment.

Sex: Female, ages: 18 Years to any

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

• Mia A. Swartz, MD, Principal investigator, EvergreenHealth Urology & Urogynecology Care