Intravaginal Devices for Pelvic Floor Motion
Trial Summary
What is the purpose of this trial?
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.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications.
What safety data exists for the treatment evaluated under different names, including leva device and PFDx device?
The safety evaluation of non-active implantable medical devices (NAIMDs) like the leva device and PFDx device highlights the need for better monitoring, as there is no global program to collect and analyze adverse events. Real-world data sources, such as electronic health records, are being explored to improve safety assessments.12345
Research Team
Lieschen Quiroz, MD
Principal Investigator
University of Oklahoma HSC
Eligibility Criteria
Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Subjects undergo baseline pelvic floor muscle assessment and device placement
Device Testing
Participants use the leva and PFDx devices to measure pelvic floor motion
Follow-up
Participants are monitored for test-retest reliability and comparison with other measurement tools
Treatment Details
Interventions
- leva device
- PFDx device
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Oklahoma
Lead Sponsor
Renovia, Inc.
Industry Sponsor