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

Sponsor
EvergreenHealth (Other)
Overall Status
Completed
CT.gov ID
NCT03199534
Collaborator
The Cleveland Clinic (Other)
20
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3
33.1
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Botulinum toxin A 50u
  • Drug: Botulinum toxin A 100u
  • Drug: Botulinum toxin A 150u
Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Prospective Cohort Trial of Pelvic Floor Chemodenervation in Patients Undergoing Physical Therapy for High Tone Pelvic Floor Dysfunction
Actual Study Start Date :
May 25, 2017
Actual Primary Completion Date :
Feb 26, 2020
Actual Study Completion Date :
Feb 26, 2020

Arms and Interventions

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:
  • BOTOX®
  • OnabotulinumtoxinA
  • 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:
  • BOTOX®
  • OnabotulinumtoxinA
  • 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:
  • BOTOX®
  • OnabotulinumtoxinA
  • Outcome Measures

    Primary Outcome Measures

    1. Change in Visual Analog Pain Scale (Non-Menstrual Pelvic Pain) score [Baseline, Week 2, Month 3, Month 6, Month 9, Month 12]

      This is a single question, "How severe is your pelvic pain at this time?"

    Secondary Outcome Measures

    1. Visual Analog Pain Scale (Dyspareunia) [Baseline, Week 2, Month 3, Month 6, Month 9, Month 12]

      This is a single question, "How severe was your pelvic pain the last time you had sexual intercourse?"

    2. Patient Global Impression of Severity [Baseline, Week 2, Month 3, Month 6, Month 9, Month 12]

      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.

    3. Pelvic Floor Distress Inventory Questionnaire [Baseline, Week 2, Month 3, Month 6, Month 9, Month 12]

      Subjects' rating on this 20-item questionnaire will be based on their bowel, bladder, and pelvic symptoms.

    4. Female Sexual Function Index [Baseline, Week 2, Month 3, Month 6, Month 9, Month 12]

      Subjects' rating on this 19-item questionnaire will be based on their sexual feelings and responses.

    5. Patient Global Impression of Improvement [Week 2, Month 3, Month 6, Month 9, Month 12]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 EvergreenHealth Urology and Urogynecology Care Kirkland Washington United States 98034

    Sponsors and Collaborators

    • EvergreenHealth
    • The Cleveland Clinic

    Investigators

    • Principal Investigator: Mia A. Swartz, MD, EvergreenHealth Urology & Urogynecology Care

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    EvergreenHealth
    ClinicalTrials.gov Identifier:
    NCT03199534
    Other Study ID Numbers:
    • HTPFD
    First Posted:
    Jun 27, 2017
    Last Update Posted:
    Jun 10, 2021
    Last Verified:
    Jun 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by EvergreenHealth
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 10, 2021