Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2025-12-25 @ 2:18 AM
NCT ID:
NCT03199534
Eligibility 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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT03199534
Study Brief:
Protocol Section:
NCT03199534