drugset / Trial / NCT03199534

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

NCT03199534 ↗

Phase 4 Completed 20 enrolled EvergreenHealth The Cleveland Clinic · collab
Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2017-05-25
Primary completion
2020-02-26
Completion
2020-02-26

Drugs

EvaluationDrugModalityDoseRoute
Subject Botulinum toxin type A Protein / enzyme biologic 50 iu —
Subject Botulinum toxin type A Protein / enzyme biologic 100 iu —
Subject Botulinum toxin type A Protein / enzyme biologic 150 iu —

Indications