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

NCT03199534 | Completed Phase 4 FDA Drug

• 1 other identifier: HTPFD
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Pain; Dyspareunia; Pelvic Floor Dysfunction

Keywords

Pelvic Pain; Dyspareunia; Pelvic Floor Dysfunction; Pelvic Floor Physical Therapy; Chemodenervation; Botulinum Toxin A; Vaginismus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Visual Analog Pain Scale (Dyspareunia)

  Baseline, Week 2, Month 3, Month 6, Month 9, Month 12

• Patient Global Impression of Severity

  Baseline, Week 2, Month 3, Month 6, Month 9, Month 12

• Pelvic Floor Distress Inventory Questionnaire

  Baseline, Week 2, Month 3, Month 6, Month 9, Month 12

• Female Sexual Function Index

  Baseline, Week 2, Month 3, Month 6, Month 9, Month 12

• Patient Global Impression of Improvement

  Week 2, Month 3, Month 6, Month 9, Month 12

Study Arms (3)

Botulinum toxin A 50u

EXPERIMENTAL

Botulinum toxin A 50 unit injection

Drug: Botulinum toxin A 50u

Botulinum toxin A 100u

EXPERIMENTAL

Botulinum toxin A 100 unit injection

Drug: Botulinum toxin A 100u

Botulinum toxin A 150u

EXPERIMENTAL

Botulinum toxin A 150 unit injection

Drug: Botulinum toxin A 150u

Interventions

Botulinum toxin A 50u DRUG

Subject will receive injection of 50u Botulinum toxin A with local sedation as an office procedure.

Also known as: BOTOX®, OnabotulinumtoxinA

Botulinum toxin A 50u

Botulinum toxin A 100u DRUG

Subject will receive injection of 100u Botulinum toxin A in either the office or while anesthetized.

Also known as: BOTOX®, OnabotulinumtoxinA

Botulinum toxin A 100u

Botulinum toxin A 150u DRUG

Subject will receive injection of 150u Botulinum toxin A while anesthetized.

Also known as: BOTOX®, OnabotulinumtoxinA

Botulinum toxin A 150u

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• EvergreenHealth: lead
• The Cleveland Clinic: collaborator

Study Sites (1)

EvergreenHealth Urology and Urogynecology Care

Kirkland, Washington, 98034, United States

Location

MeSH Terms

Conditions

Pelvic Pain; Dyspareunia; Vaginismus

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders; Vaginal Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Mia A. Swartz, MD

  EvergreenHealth Urology & Urogynecology Care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2017
• First Posted: June 27, 2017
• Study Start: May 25, 2017
• Primary Completion: February 26, 2020
• Study Completion: February 26, 2020
• Last Updated: June 10, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)