Clinical trial NCT03199534: A Trial of Pelvic Floor Chemodenervation in Patients Undergoing Physical Therapy for High Tone Pelvic Floor Dysfunction
Official title: A Prospective Cohort Trial of Pelvic Floor Chemodenervation in Patients Undergoing Physical Therapy for High Tone Pelvic Floor Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pelvic Pain
Dyspareunia
Pelvic Floor Dysfunction
Keywords: Pelvic Pain
Dyspareunia
Pelvic Floor Dysfunction
Pelvic Floor Physical Therapy
Chemodenervation
Botulinum Toxin A
Vaginismus
Lead sponsor: EvergreenHealth
Sponsor class: OTHER
Collaborators: name: The Cleveland Clinic
First posted: 2017-06-27
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

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

Primary outcomes:
measure: Change in Visual Analog Pain Scale (Non-Menstrual Pelvic Pain) score
timeFrame: Baseline, Week 2, Month 3, Month 6, Month 9, Month 12
Secondary outcomes:
measure: Visual Analog Pain Scale (Dyspareunia)
timeFrame: Baseline, Week 2, Month 3, Month 6, Month 9, Month 12
measure: Patient Global Impression of Severity
timeFrame: Baseline, Week 2, Month 3, Month 6, Month 9, Month 12
measure: Pelvic Floor Distress Inventory Questionnaire
timeFrame: Baseline, Week 2, Month 3, Month 6, Month 9, Month 12
measure: Female Sexual Function Index
timeFrame: Baseline, Week 2, Month 3, Month 6, Month 9, Month 12
measure: Patient Global Impression of Improvement
timeFrame: Week 2, Month 3, Month 6, Month 9, Month 12
Other outcomes:
Locations:
city: Kirkland
country: United States
facility: EvergreenHealth Urology and Urogynecology Care
state: Washington
Study officials:
affiliation: EvergreenHealth Urology & Urogynecology Care
name: Mia A. Swartz, MD
role: PRINCIPAL_INVESTIGATOR
References: