NCT03199534

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: EvergreenHealth · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Botulinum toxin A 50u	Subject will receive injection of 50u Botulinum toxin A with local sedation as an office procedure.
DRUG	Botulinum toxin A 100u	Subject will receive injection of 100u Botulinum toxin A in either the office or while anesthetized.
DRUG	Botulinum toxin A 150u	Subject will receive injection of 150u Botulinum toxin A while anesthetized.

Timeline

• Start date: 2017-05-25
• Primary completion: 2020-02-26
• Completion: 2020-02-26
• First posted: 2017-06-27
• Last updated: 2021-06-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study