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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
Reports they are able to perform a kegel exercise
Female
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You are able to do a Kegel exercise.
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You are a woman.
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You are a female.

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
98,152 Total Patients Enrolled
Lieschen Quiroz, MDPrincipal InvestigatorUniversity of Oklahoma HSC
4 Previous Clinical Trials
343 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age limit for participation in this clinical trial restricted to individuals under 25?

"The criteria for participation in this trial necessitates that potential participants are between 18 and 100 years old. Additionally, there is a separate cohort of minors aged under 18 and seniors over 65 who can be included into the study."

Answered by AI

How many people have enrolled in this clinical trial thus far?

"Affirmative. According to the data on clinicaltrials.gov, this study is still actively searching for participants. This medical trial was first listed on March 25th 2021 and has been updated as recently as May 17th 2022; 30 volunteers are needed from two different sites."

Answered by AI

Is this experimental investigation presently enrolling participants?

"Affirmative. Information on clinicaltrials.gov suggests that this medical study, which was initially posted on March 25th 2021 and recently updated on May 17th 2022, is actively searching for 30 individuals from 2 different locations to participate in the trial."

Answered by AI

Who is eligible to participate in this medical research?

"Patients affected by pelvic floor disorders who fall between 18 and 100 years of age can apply to join this clinical trial. Currently, 30 individuals are being recruited."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
~7 spots leftby Mar 2025