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

NCT ID: NCT03199534

Last Updated: 2021-06-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-25
• Study Completion Date: 2020-02-26

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.

Conditions

Pelvic Pain; Dyspareunia; Pelvic Floor Dysfunction

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Botulinum toxin A 50u

Botulinum toxin A 50 unit injection

Group Type: EXPERIMENTAL

Botulinum toxin A 50u

Intervention Type: DRUG

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

Botulinum toxin A 100u

Botulinum toxin A 100 unit injection

Group Type: EXPERIMENTAL

Botulinum toxin A 100u

Intervention Type: DRUG

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

Botulinum toxin A 150u

Botulinum toxin A 150 unit injection

Group Type: EXPERIMENTAL

Botulinum toxin A 150u

Intervention Type: DRUG

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

Interventions

Botulinum toxin A 50u

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

Intervention Type: DRUG

Botulinum toxin A 100u

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

Intervention Type: DRUG

Botulinum toxin A 150u

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

Intervention Type: DRUG

Other Intervention Names

BOTOX®; OnabotulinumtoxinA; BOTOX®; OnabotulinumtoxinA; BOTOX®; OnabotulinumtoxinA

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: collaborator

EvergreenHealth

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mia A. Swartz, MD

Role: PRINCIPAL_INVESTIGATOR

EvergreenHealth Urology & Urogynecology Care

Locations

EvergreenHealth Urology and Urogynecology Care

Kirkland, Washington, United States

Countries

United States

Other Identifiers

HTPFD

Identifier Type: -

Identifier Source: org_study_id