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

NCT03199534 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-06-10

No results posted yet for this study

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.

Conditions

  • Pelvic Pain
  • Dyspareunia
  • Pelvic Floor Dysfunction

Interventions

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.

Sponsors & Collaborators

  • The Cleveland Clinic

    collaborator OTHER

  • EvergreenHealth

    lead OTHER

Principal Investigators

  • Mia A. Swartz, MD · EvergreenHealth Urology & Urogynecology Care

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-25
Primary Completion
2020-02-26
Completion
2020-02-26
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03199534 on ClinicalTrials.gov