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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Prospective Cohort Trial of Pelvic Floor Chemodenervation in Patients Undergoing Physical Therapy for High Tone Pelvic Floor Dysfunction

Conditions
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Pelvic Pain, Dyspareunia, Pelvic Floor Dysfunction

Intervention / Treatment
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* Drug: Botulinum toxin A 50u
* Drug: Botulinum toxin A 100u
* Drug: Botulinum toxin A 150u


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Botulinum toxin A 50u<br>Botulinum toxin A 50 unit injection | Drug: Botulinum toxin A 50u<br>* Subject will receive injection of 50u Botulinum toxin A with local sedation as an office procedure.<br>* Other names: OnabotulinumtoxinA;|
| Experimental: Botulinum toxin A 100u<br>Botulinum toxin A 100 unit injection | Drug: Botulinum toxin A 100u<br>* Subject will receive injection of 100u Botulinum toxin A in either the office or while anesthetized.<br>* Other names: OnabotulinumtoxinA;|
| Experimental: Botulinum toxin A 150u<br>Botulinum toxin A 150 unit injection | Drug: Botulinum toxin A 150u<br>* Subject will receive injection of 150u Botulinum toxin A while anesthetized.<br>* Other names: OnabotulinumtoxinA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Visual Analog Pain Scale (Non-Menstrual Pelvic Pain) score | This is a single question, How severe is your pelvic pain at this time? | Baseline, Week 2, Month 3, Month 6, Month 9, Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Pain Scale (Dyspareunia) | This is a single question, How severe was your pelvic pain the last time you had sexual intercourse? | Baseline, Week 2, Month 3, Month 6, Month 9, Month 12 | 
| Patient Global Impression of Severity | 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. | Baseline, Week 2, Month 3, Month 6, Month 9, Month 12 | 
| Pelvic Floor Distress Inventory Questionnaire | Subjects' rating on this 20-item questionnaire will be based on their bowel, bladder, and pelvic symptoms. | Baseline, Week 2, Month 3, Month 6, Month 9, Month 12 | 
| Female Sexual Function Index | Subjects' rating on this 19-item questionnaire will be based on their sexual feelings and responses. | Baseline, Week 2, Month 3, Month 6, Month 9, Month 12 | 
| Patient Global Impression of Improvement | 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. | Week 2, Month 3, Month 6, Month 9, Month 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pelvic Pain, Dyspareunia, Pelvic Floor Dysfunction, Pelvic Floor Physical Therapy, Chemodenervation, Botulinum Toxin A, Vaginismus