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

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

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.

Study Overview

• Status: Completed
• Conditions: Pelvic Pain; Dyspareunia; Pelvic Floor Dysfunction
• Intervention / Treatment: Drug: Botulinum toxin A 50u; Drug: Botulinum toxin A 100u; Drug: Botulinum toxin A 150u

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Washington
    • Kirkland, Washington, United States, 98034
      • EvergreenHealth Urology and Urogynecology Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Botulinum toxin A 50u; Botulinum toxin A 50 unit injection	Drug: Botulinum toxin A 50u; Subject will receive injection of 50u Botulinum toxin A with local sedation as an office procedure.; Other Names: OnabotulinumtoxinA; BOTOX®
Experimental: Botulinum toxin A 100u; Botulinum toxin A 100 unit injection	Drug: Botulinum toxin A 100u; Subject will receive injection of 100u Botulinum toxin A in either the office or while anesthetized.; Other Names: OnabotulinumtoxinA; BOTOX®
Experimental: Botulinum toxin A 150u; Botulinum toxin A 150 unit injection	Drug: Botulinum toxin A 150u; Subject will receive injection of 150u Botulinum toxin A while anesthetized.; Other Names: OnabotulinumtoxinA; BOTOX®

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: EvergreenHealth
• Collaborators: The Cleveland Clinic
• Investigators: Principal Investigator: Mia A. Swartz, MD, EvergreenHealth Urology & Urogynecology Care

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2017
• Primary Completion (Actual): February 26, 2020
• Study Completion (Actual): February 26, 2020

Study Registration Dates

• First Submitted: June 13, 2017
• First Submitted That Met QC Criteria: June 23, 2017
• First Posted (Actual): June 27, 2017

Study Record Updates

• Last Update Posted (Actual): June 10, 2021
• Last Update Submitted That Met QC Criteria: June 8, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Botulinum Toxin A; Pelvic Floor Dysfunction; Dyspareunia; Pelvic Pain; Vaginismus; Pelvic Floor Physical Therapy; Chemodenervation
• Additional Relevant MeSH Terms: Mental Disorders; Pain; Neurologic Manifestations; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Pelvic Pain; Dyspareunia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: HTPFD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: There is no plan to share individual participant data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes