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

• Status: Completed
• Trial end date: 2020-02-26
• Target enrollment: 0
• Participant gender: Female

Summary

This study assesses whether the addition of chemodenervation to an established regimen of pelvic floor physical therapy for painful high tone pelvic floor dysfunction improves patients' objective and subjective outcomes. Study subjects will select one of three treatment approaches: injection of 50 units Botulinum toxin A with local sedation as an office procedure, injection of 100u BoNTA-cosmetic in either the office or while anesthetized, or injection of 150 units Botulinum toxin A while anesthetized.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: EvergreenHealth
• Collaborator: The Cleveland Clinic
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A

Criteria

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