drugset / Trial / NCT03199534
A Trial of Pelvic Floor Chemodenervation in Patients Undergoing Physical Therapy for High Tone Pelvic Floor Dysfunction
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 | — |