PFDx device and leva device for Pelvic Floor Dysfunction

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
OU Physicians, Oklahoma City, OKPelvic Floor DysfunctionPFDx device and leva device - Device
Eligibility
18 - 100
Female
What conditions do you have?
Select

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.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 9 Secondary · Reporting Duration: Through final study visit (about 3 months)

Month 3
Compare PFDx angle change measurements with Modified Oxford, Brinks
Compare PFDx to a perineometer
Compare leva angle change measurements with Modified Oxford, Brinks
Compare leva to a perineometer
Determine the test-retest reliability of Manual muscle testing angle measurements over 2 time points
Determine the test-retest reliability of PFDx angle measurements over 2 time points
Determine the test-retest reliability of leva angle measurements over 2 time points
Determine the test-retest reliability of perineometry angle measurements over 2 time points
Determine the test-retest reliability of ultrasound angle measurements over 2 time points
Validate leva measurements with transperineal ultrasound (TPUS)

Trial Safety

Trial Design

1 Treatment Group

Device usage
1 of 1

Experimental Treatment

30 Total Participants · 1 Treatment Group

Primary Treatment: PFDx device and leva device · No Placebo Group · N/A

Device usage
Device
Experimental Group · 1 Intervention: PFDx device and leva device · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: through final study visit (about 3 months)

Who is running the clinical trial?

Renovia, Inc.Industry Sponsor
5 Previous Clinical Trials
505 Total Patients Enrolled
University of OklahomaLead Sponsor
424 Previous Clinical Trials
97,874 Total Patients Enrolled
Lieschen Quiroz, MDPrincipal InvestigatorUniversity of Oklahoma HSC
4 Previous Clinical Trials
376 Total Patients Enrolled

Eligibility Criteria

Age 18 - 100 · Female Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are able to do a Kegel exercise.
You are a woman.
You are a female.

Who else is applying?

What state do they live in?
California100.0%
How old are they?
18 - 65100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.