LEVA® Device for Bowel Incontinence

Overseen By Ushma Patel, MD

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: University of Wisconsin, Madison

Disqualifiers: Colorectal malignancy, Inflammatory bowel disease, Rectal prolapse, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 8-16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if using the Leva Pelvic Health System for 8 weeks is as effective as using it for 16 weeks in treating fecal incontinence in women. Fecal incontinence involves any uncontrolled loss of stool occurring at least once a month and is bothersome enough to require treatment. Participants will complete surveys and use the Leva device, which aids in pelvic health. Women who have experienced fecal incontinence for the past three months and can stand for at least three minutes daily for training may be suitable candidates. As a Phase 4 trial, this study involves an FDA-approved treatment and seeks to understand its benefits for more patients.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for The Leva Pelvic Health System?

Research shows that the Leva Pelvic Health System is generally safe. The FDA has approved it for treating long-term bowel control issues, confirming its safety for this use. Previous studies have shown it can work well without causing serious side effects. The system uses a phone app and a vaginal probe to help strengthen pelvic floor muscles.

For safety, updates are sent every four weeks during trials. This regular check helps catch and fix any problems quickly. Overall, the Leva device is easy for users to handle and offers a non-surgical, non-drug option, often resulting in fewer side effects compared to other treatments. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the Leva Pelvic Health System for bowel incontinence because it offers a unique, non-invasive approach compared to standard treatments like medications and surgery. Unlike medications that usually target symptoms or surgery that alters body structures, the Leva system utilizes a wearable device that helps strengthen pelvic floor muscles through guided exercises, potentially improving bowel control naturally. What makes it stand out is the ability to use it at home, which can empower patients to manage their condition more independently and conveniently. This approach not only aims to improve quality of life but also minimizes the risks and side effects associated with more invasive treatments.

What evidence suggests that the Leva Pelvic Health System is effective for bowel incontinence?

Research shows that the Leva Pelvic Health System can effectively treat long-term bowel control problems by strengthening the pelvic floor muscles, which are crucial for controlling bowel movements. Studies have found that women using this device experience significant improvements in their symptoms and overall quality of life. In one study, researchers used a bowel diary and symptom severity to measure the treatment's effectiveness. Participants in this trial will use the Leva device for either 8 weeks or 16 weeks to assess its effectiveness. The FDA has cleared the Leva device for treating chronic fecal incontinence, confirming its effectiveness for this condition. ^{1 6 7 8 9}

Who Is on the Research Team?

Dobie Giles, MD

Principal Investigator

University of Wisconsin, Madison

Are You a Good Fit for This Trial?

This trial is for adult women over 18 with fecal incontinence, occurring at least monthly and seeking treatment. Participants must be able to stand for daily training, speak/read English (as the app is English-only), have an email, own a smartphone, and can use apps. Exclusions include intolerance to vaginal devices, certain medical conditions like colorectal malignancy or inflammatory bowel disease, recent pelvic surgeries or pregnancy.

Inclusion Criteria

I have had uncontrollable bowel movements at least once a month for the last 3 months and want treatment.

I am an adult woman aged 18 or older.

I can stand and train for at least 3 minutes daily.

Exclusion Criteria

I have been diagnosed with colorectal or anal cancer.

My inflammatory bowel disease is not under control.

Inability to tolerate insertion of vaginal device (e.g., vaginal agenesis, vaginal stenosis, unremitting pelvic pain, within 12 weeks postpartum)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the Leva Pelvic Health System for either 8 or 16 weeks to treat fecal incontinence

8-16 weeks

Surveys at 0, 16, and 24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with surveys conducted at 1 and 2 years

Long-term

Surveys at 1 and 2 years

What Are the Treatments Tested in This Trial?

Interventions

• The Leva Pelvic Health System

Trial Overview The study tests the Leva Pelvic Health System's effectiveness on treating fecal incontinence over different durations: comparing results from using it for 8 weeks versus 16 weeks. Women will use the device alongside completing surveys about their condition.

How Is the Trial Designed?

Group I: 8 week use of Leva Experimental Treatment 1 Intervention

Group II: 16 week use of Leva Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06152224

Use of the LEVA® Pelvic Health System for Fecal ... This study will assess whether 8 weeks of use of the Leva Pelvic Health System (Leva) is non-inferior to 16 weeks of use for the treatment of chronic fecal ...

2. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/24/NCT06152224/Prot_SAP_000.pdf

Use of the LEVA® Pelvic Health System for Fecal ... While the primary outcomes assessed during this study included measures of urinary incontinence symptoms, a secondary outcome was the CRADI-8, a ...

3. urologytimes.com urologytimes.com/view/fda-grants-clearance-to-leva-pelvic-health-system-for-chronic-fecal-incontinence

FDA grants clearance to leva Pelvic Health System for ... St. Mark's score from baseline to week 10 was the primary outcome measure. Secondary end points included change in 2-week bowel diary and fecal ...

4. dtxalliance.org dtxalliance.org/products/leva/

Leva The Leva Pelvic Health System treats female urinary and chronic fecal incontinence through rehabilitation and training of weak pelvic floor muscles.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9300000/

Use of a motion‐based digital therapeutic in women with ... In this pilot study, there was significant improvement in FI symptom‐specific severity and quality of life using a vaginal, motion‐based device for biofeedback.

6. 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.

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf21/K213913.pdf

June 30, 2022 Renovia Inc. Jacqueline Schmainda ... The data from the referenced clinical studies supports the leva Pelvic Health System can serve as a safe and effective aid to provide ...

8. nafc.org nafc.org/featured-product-partner-leva/

Featured Partner the leva Pelvic Health System In addition to UI, the Leva Pelvic Health System is also FDA-cleared for the treatment of chronic fecal incontinence and general pelvic floor muscle ...

9. levacares.com levacares.com/wp-content/uploads/2024/12/2024-Leva-Patient-Brochure_PM_000272.01_final_digital-PDF.pdf

Bladder leakage can be a serious challenge for women. The Leva Pelvic Health System is a non-medication, non-surgical first-line treatment for stress, mixed, and urgency urinary incontinence (UI).