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

Primary Purpose

Pelvic Pain, Dyspareunia, Pelvic Floor Dysfunction

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Botulinum toxin A 50u
Botulinum toxin A 100u
Botulinum toxin A 150u
Sponsored by
EvergreenHealth
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Pain focused on measuring Pelvic Pain, Dyspareunia, Pelvic Floor Dysfunction, Pelvic Floor Physical Therapy, Chemodenervation, Botulinum Toxin A, Vaginismus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • EvergreenHealth Urology and Urogynecology Care

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Botulinum toxin A 50u

Botulinum toxin A 100u

Botulinum toxin A 150u

Arm Description

Botulinum toxin A 50 unit injection

Botulinum toxin A 100 unit injection

Botulinum toxin A 150 unit injection

Outcomes

Primary Outcome Measures

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?"

Secondary Outcome Measures

Visual Analog Pain Scale (Dyspareunia)
This is a single question, "How severe was your pelvic pain the last time you had sexual intercourse?"
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.
Pelvic Floor Distress Inventory Questionnaire
Subjects' rating on this 20-item questionnaire will be based on their bowel, bladder, and pelvic symptoms.
Female Sexual Function Index
Subjects' rating on this 19-item questionnaire will be based on their sexual feelings and responses.
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.

Full Information

First Posted
June 13, 2017
Last Updated
June 8, 2021
Sponsor
EvergreenHealth
Collaborators
The Cleveland Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT03199534
Brief Title
A Trial of Pelvic Floor Chemodenervation in Patients Undergoing Physical Therapy for High Tone Pelvic Floor Dysfunction
Official Title
A Prospective Cohort Trial of Pelvic Floor Chemodenervation in Patients Undergoing Physical Therapy for High Tone Pelvic Floor Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
May 25, 2017 (Actual)
Primary Completion Date
February 26, 2020 (Actual)
Study Completion Date
February 26, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EvergreenHealth
Collaborators
The Cleveland Clinic

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Pain, Dyspareunia, Pelvic Floor Dysfunction
Keywords
Pelvic Pain, Dyspareunia, Pelvic Floor Dysfunction, Pelvic Floor Physical Therapy, Chemodenervation, Botulinum Toxin A, Vaginismus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Botulinum toxin A 50u
Arm Type
Experimental
Arm Description
Botulinum toxin A 50 unit injection
Arm Title
Botulinum toxin A 100u
Arm Type
Experimental
Arm Description
Botulinum toxin A 100 unit injection
Arm Title
Botulinum toxin A 150u
Arm Type
Experimental
Arm Description
Botulinum toxin A 150 unit injection
Intervention Type
Drug
Intervention Name(s)
Botulinum toxin A 50u
Other Intervention Name(s)
BOTOX®, OnabotulinumtoxinA
Intervention Description
Subject will receive injection of 50u Botulinum toxin A with local sedation as an office procedure.
Intervention Type
Drug
Intervention Name(s)
Botulinum toxin A 100u
Other Intervention Name(s)
BOTOX®, OnabotulinumtoxinA
Intervention Description
Subject will receive injection of 100u Botulinum toxin A in either the office or while anesthetized.
Intervention Type
Drug
Intervention Name(s)
Botulinum toxin A 150u
Other Intervention Name(s)
BOTOX®, OnabotulinumtoxinA
Intervention Description
Subject will receive injection of 150u Botulinum toxin A while anesthetized.
Primary Outcome Measure Information:
Title
Change in Visual Analog Pain Scale (Non-Menstrual Pelvic Pain) score
Description
This is a single question, "How severe is your pelvic pain at this time?"
Time Frame
Baseline, Week 2, Month 3, Month 6, Month 9, Month 12
Secondary Outcome Measure Information:
Title
Visual Analog Pain Scale (Dyspareunia)
Description
This is a single question, "How severe was your pelvic pain the last time you had sexual intercourse?"
Time Frame
Baseline, Week 2, Month 3, Month 6, Month 9, Month 12
Title
Patient Global Impression of Severity
Description
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.
Time Frame
Baseline, Week 2, Month 3, Month 6, Month 9, Month 12
Title
Pelvic Floor Distress Inventory Questionnaire
Description
Subjects' rating on this 20-item questionnaire will be based on their bowel, bladder, and pelvic symptoms.
Time Frame
Baseline, Week 2, Month 3, Month 6, Month 9, Month 12
Title
Female Sexual Function Index
Description
Subjects' rating on this 19-item questionnaire will be based on their sexual feelings and responses.
Time Frame
Baseline, Week 2, Month 3, Month 6, Month 9, Month 12
Title
Patient Global Impression of Improvement
Description
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.
Time Frame
Week 2, Month 3, Month 6, Month 9, Month 12

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mia A. Swartz, MD
Organizational Affiliation
EvergreenHealth Urology & Urogynecology Care
Official's Role
Principal Investigator
Facility Information:
Facility Name
EvergreenHealth Urology and Urogynecology Care
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98034
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share individual participant data.

Learn more about this trial

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

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