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Intravaginal Devices for Pelvic Floor Motion

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
No Placebo-Only Group

Summary

This trial uses Leva and PFDx devices to measure how well the pelvic floor muscles work in women aged 18 and older. The devices help doctors see muscle strength by measuring movements during exercises.

Eligible Conditions
  • Pelvic Floor Disorders
  • Pelvic Floor Dysfunction

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Validate leva measurements with transperineal ultrasound (TPUS)
Secondary study objectives
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
473 Previous Clinical Trials
93,651 Total Patients Enrolled
Lieschen Quiroz, MDPrincipal InvestigatorUniversity of Oklahoma HSC
4 Previous Clinical Trials
343 Total Patients Enrolled
~6 spots leftby Dec 2025
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