Intravaginal Devices for Pelvic Floor Disorders

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how well two devices, leva and PFDx, measure pelvic floor movements compared to an ultrasound (TPUS). The study assesses whether the devices accurately track changes during pelvic exercises, such as Kegels. Women with a vagina who can perform Kegel exercises and have a BMI under 30 may be suitable candidates. Participants will use the devices and complete a survey to help researchers understand device functionality. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance pelvic health assessment tools.

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 prior data suggests that these devices are safe for evaluating pelvic floor motion?

Research has shown that the leva device meets important medical standards and has been tested for safety. It has been verified to ensure it won't cause harm during use, particularly concerning electrical safety. Previous studies found that most users handle the leva device well, with very few expected risks.

For the PFDx device, detailed safety information is less available. However, its classification in a trial that doesn't require a specific phase suggests it is likely low-risk, meaning serious side effects are not expected.

Overall, both devices are designed to be safe for participants and are unlikely to cause harm during the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the leva and PFDx devices because they offer a new way to evaluate and potentially improve pelvic floor motion. Unlike traditional treatments for pelvic floor disorders, which often involve physical therapy or surgical interventions, these devices provide a non-invasive method to assess and support pelvic floor muscles. The leva device uses advanced motion sensors to track pelvic floor movements, while the PFDx device offers a detailed evaluation of muscle function. This combination of innovative technology could lead to better, personalized treatment plans for individuals with pelvic floor issues.

What evidence suggests that the leva and PFDx devices are effective for evaluating pelvic floor motion?

Research shows that the Leva device effectively strengthens pelvic floor muscles. Studies have found it works faster and better than traditional exercises for stress urinary incontinence, which causes urine leakage during activities like laughing, coughing, or sneezing. In several trials, users reported a significant reduction in urinary incontinence symptoms and maintained these improvements over time.

For the PFDx device, a review of studies found that combining electrical stimulation (a gentle electric current) with pelvic floor exercises can greatly reduce symptoms of pelvic floor disorders, such as bladder control issues. Evidence also shows that using pressure-mediated biofeedback (real-time feedback on muscle activity) with exercises is more effective than exercises alone. In this trial, participants will use both the Leva and PFDx devices to evaluate their effectiveness in improving pelvic floor movement, which is crucial for managing these conditions. ^{4 6 7 8 9}

Who Is on the Research Team?

Lieschen Quiroz, MD

Principal Investigator

University of Oklahoma HSC

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• leva device
• PFDx device

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1.

advances.massgeneral.org

advances.massgeneral.org/urology/journal.aspx?id=2407

Real World Effectiveness of Pelvic Floor Muscle Training ...

Digital Therapeutic Device for Pelvic Floor Muscle Training Provides Faster, Better Results Than Conventional Exercises. Milena M. Weinstein ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8936159/

Digital Therapeutic Device for Urinary Incontinence

Pelvic floor muscle training using a digital therapeutic device is superior to home pelvic floor muscle training for treatment of stress urinary incontinence.

3.

levacares.com

levacares.com/for-hcps/clinical-results-with-leva/

Leva Clinical Results

Uncover Leva therapy clinical results: Significant reduction in urinary incontinence symptoms, long-term efficacy, and high patient adherence in multiple ...

4.

tandfonline.com

tandfonline.com/doi/full/10.1080/13696998.2025.2494940?af=R

U.S. payer budget impact of the Leva Pelvic Health System ...

Use of the Leva device has improved UI symptoms in women in two randomized clinical trials, with one trial evaluating 24-month follow-up with consistent ...

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04027335

Use of the Leva Pelvic Digital Health System in Women ...

Pilot study to understand the impact of a digital health system, including a phone app and a vaginal probe to treat fecal incontinence in women.

6.

clinicaltrials.gov

clinicaltrials.gov/ct2/show/NCT04826939?draw=2

NCT04826939 | Intravaginal Devices for Pelvic Floor Motion

Also called a data safety and monitoring board, or DSMB. ... The leva and PFDx devices accurately reflect pelvic floor motion consistent with TPUS evaluation.

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10047914/

Multifunctional Evaluation Technology for Diagnosing ...

Multifunctional evaluation technology for diagnosing malfunctions of regional pelvic floor muscles based on stretchable electrode array probe.

8.

withpower.com

withpower.com/trial/phase-pelvic-floor-disorders-2-2021-3c21c

Intravaginal Devices for Pelvic Floor Motion

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 ...

9.

sciencedirect.com

sciencedirect.com/science/article/pii/S2050116120300076

Electromyographic Evaluation of the Pelvic Muscles Activity ...

This study documented that the HIFEM procedure was significantly more effective than electrical stimulation in treatment of PFD in postpartum women.