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PFDx device and leva device for Pelvic Floor Dysfunction

N/A
Waitlist Available
Led By Lieschen Quiroz, MD
Research Sponsored by University of Oklahoma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through final study visit (about 3 months)
Awards & highlights

Study Summary

This trial found that the leva and PFDx devices accurately reflect pelvic floor motion during a voluntary contraction, as compared to other measurements.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through final study visit (about 3 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and through final study visit (about 3 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Validate leva measurements with transperineal ultrasound (TPUS)
Secondary outcome measures
Compare PFDx angle change measurements with Modified Oxford, Brinks
Compare PFDx to a perineometer
Compare leva angle change measurements with Modified Oxford, Brinks
+6 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Device usageExperimental Treatment1 Intervention
All participants will complete a survey and undergo an evaluation to test the movement of their pelvic floor with the PFDx device and leva device
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PFDx device and leva device
2021
N/A
~30

Find a Location

Who is running the clinical trial?

Renovia, Inc.Industry Sponsor
5 Previous Clinical Trials
505 Total Patients Enrolled
University of OklahomaLead Sponsor
455 Previous Clinical Trials
95,626 Total Patients Enrolled
Lieschen Quiroz, MDPrincipal InvestigatorUniversity of Oklahoma HSC
4 Previous Clinical Trials
343 Total Patients Enrolled
~7 spots leftby May 2025
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