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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

Tracking Information
First Submitted Date  ICMJE June 13, 2017
First Posted Date  ICMJE June 27, 2017
Last Update Posted Date October 17, 2019
Actual Study Start Date  ICMJE May 25, 2017
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 23, 2017)
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?"
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03199534 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2017)
  • 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?"
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Trial of Pelvic Floor Chemodenervation in Patients Undergoing Physical Therapy for High Tone Pelvic Floor Dysfunction
Official Title  ICMJE A Prospective Cohort Trial of Pelvic Floor Chemodenervation in Patients Undergoing Physical Therapy for High Tone Pelvic Floor Dysfunction
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Pelvic Pain
  • Dyspareunia
  • Pelvic Floor Dysfunction
Intervention  ICMJE
  • 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
  • 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
  • Drug: Botulinum toxin A 150u
    Subject will receive injection of 150u Botulinum toxin A while anesthetized.
    Other Names:
    • BOTOX®
    • OnabotulinumtoxinA
Study Arms  ICMJE
  • Experimental: Botulinum toxin A 50u
    Botulinum toxin A 50 unit injection
    Intervention: Drug: Botulinum toxin A 50u
  • Experimental: Botulinum toxin A 100u
    Botulinum toxin A 100 unit injection
    Intervention: Drug: Botulinum toxin A 100u
  • Experimental: Botulinum toxin A 150u
    Botulinum toxin A 150 unit injection
    Intervention: Drug: Botulinum toxin A 150u
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: June 23, 2017)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2020
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03199534
Other Study ID Numbers  ICMJE HTPFD
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: There is no plan to share individual participant data.
Responsible Party EvergreenHealth
Study Sponsor  ICMJE EvergreenHealth
Collaborators  ICMJE The Cleveland Clinic
Investigators  ICMJE
Principal Investigator: Mia A. Swartz, MD EvergreenHealth Urology & Urogynecology Care
PRS Account EvergreenHealth
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP