30 Participants Needed

Intravaginal Devices for Pelvic Floor Motion

Recruiting at 1 trial location
CZ
KW
Overseen ByKyra Woods, BA
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: University of Oklahoma
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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

LQ

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.
See 3 more

Exclusion Criteria

Known, untreated pelvic, vaginal or urinary tract infection
Currently pregnant
You have a severe form of pelvic organ prolapse.
See 1 more

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
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

Find a Clinic Near You

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

References

Three-year follow-up after less-invasive left ventricular assist device exchange to HeartMate 3™. [2022]
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]
The dilemma of reporting device-related adverse events. [2016]
Evaluating the Safety Profile of Non-Active Implantable Medical Devices Compared with Medicines. [2018]
Analysis of reported adverse events of pipeline stents for intracranial aneurysms using the FDA MAUDE database. [2023]