Intravaginal Devices for Pelvic Floor Motion

Recruiting at 1 trial location

Overseen By Kyra Woods, BA

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Oklahoma

Disqualifiers: Pelvic prolapse, Untreated infections, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

30 Participants Needed

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. ^{1 2 3 4 5}

Research Team

Lieschen Quiroz, MD

Principal Investigator

University of Oklahoma HSC

Eligibility Criteria

Inclusion Criteria

BMI <30

You are able to do a Kegel exercise.

You are a female.

Exclusion Criteria

Known, untreated pelvic, vaginal or urinary tract infection

Currently pregnant

You have a severe form of pelvic organ prolapse.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Baseline Assessment

Subjects undergo baseline pelvic floor muscle assessment and device placement

1 day

1 visit (in-person)

Device Testing

Participants use the leva and PFDx devices to measure pelvic floor motion

1-2 weeks

1-2 visits (in-person)

Follow-up

Participants are monitored for test-retest reliability and comparison with other measurement tools

3 months

2 visits (in-person)

Treatment Details

Interventions

• leva device
• PFDx device

Participant Groups

Group I: Device usage Experimental Treatment 1 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

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials

484

Recruited

95,900+

Renovia, Inc.

Industry Sponsor

Trials

6

Recruited

540+

Findings from Research

In a study of six patients who underwent a device upgrade to the HeartMate 3™ LVAD, the three-year survival rate was 100%, indicating excellent safety and efficacy of the new device.

While the HeartMate 3™ showed superior hemocompatibility and reduced pump thrombosis, there was a high risk of local re-infection in patients who exchanged their devices due to severe infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three-year follow-up after less-invasive left ventricular assist device exchange to HeartMate 3™. Hanke, JS., Mariani, S., Merzah, AS., et al.[2022]

A systematic review of 82 publications on the safety of rhBMP-2 for spinal fusion revealed that the most effective databases for identifying adverse effects data are the Science Citation Index (SCI) and EMBASE, both achieving a sensitivity of 62%.

To comprehensively identify all relevant studies, a combination of multiple sources including SCI, EMBASE, MEDLINE/PubMED, and additional methods like reference checking is necessary, highlighting the complexity of gathering complete safety data for medical devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The contribution of different information sources to identify adverse effects of a medical device: a case study using a systematic review of spinal fusion. Golder, S., Wright, K., Rodgers, M.[2018]

The article highlights the challenges medical device companies face in deciding whether to report adverse events related to device implants to regulatory authorities.

It discusses UK vigilance guidance documents that provide a framework to help manufacturers make informed decisions about reporting, which can enhance safety and accountability in the medical device industry.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The dilemma of reporting device-related adverse events. Donawa, M.[2016]

There is a significant gap in the safety evaluation of non-active implantable medical devices (NAIMDs) compared to medicines, particularly in the absence of a global program for collecting and analyzing adverse events and product quality issues.

Adopting methodologies from drug safety evaluations, such as utilizing real-world data sources like electronic health records and implementing unique device identifiers (UDI), could enhance the ongoing monitoring and assessment of NAIMD safety throughout their entire life cycle.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the Safety Profile of Non-Active Implantable Medical Devices Compared with Medicines. Pane, J., Coloma, PM., Verhamme, KM., et al.[2018]

References

1. Italy pubmed.ncbi.nlm.nih.gov

Three-year follow-up after less-invasive left ventricular assist device exchange to HeartMate 3™. [2022]

2. England pubmed.ncbi.nlm.nih.gov

The contribution of different information sources to identify adverse effects of a medical device: a case study using a systematic review of spinal fusion. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

The dilemma of reporting device-related adverse events. [2016]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Evaluating the Safety Profile of Non-Active Implantable Medical Devices Compared with Medicines. [2018]

5. Korea (South) pubmed.ncbi.nlm.nih.gov

Analysis of reported adverse events of pipeline stents for intracranial aneurysms using the FDA MAUDE database. [2023]