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

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ClinicalTrials.gov Identifier: NCT03199534
Recruitment Status : Active, not recruiting
First Posted : June 27, 2017
Last Update Posted : October 17, 2019
Sponsor:
Collaborator:
The Cleveland Clinic
Information provided by (Responsible Party):
EvergreenHealth

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
Pelvic Pain Dyspareunia Pelvic Floor Dysfunction 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 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
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox Pelvic Pain

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




Primary Outcome Measures :
  1. Change in Visual Analog Pain Scale (Non-Menstrual Pelvic Pain) score [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03199534


Locations
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United States, Washington
EvergreenHealth Urology and Urogynecology Care
Kirkland, Washington, United States, 98034
Sponsors and Collaborators
EvergreenHealth
The Cleveland Clinic
Investigators
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Principal Investigator: Mia A. Swartz, MD EvergreenHealth Urology & Urogynecology Care

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Responsible Party: EvergreenHealth
ClinicalTrials.gov Identifier: NCT03199534     History of Changes
Other Study ID Numbers: HTPFD
First Posted: June 27, 2017    Key Record Dates
Last Update Posted: October 17, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share individual participant data.

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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:
Pelvic Pain
Dyspareunia
Pelvic Floor Dysfunction
Pelvic Floor Physical Therapy
Chemodenervation
Botulinum Toxin A
Vaginismus
Additional relevant MeSH terms:
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Dyspareunia
Pelvic Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Sexual Dysfunction, Physiological
Genital Diseases, Male
Genital Diseases, Female
Sexual Dysfunctions, Psychological
Mental Disorders
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents