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Behavioural Intervention

LEVA® Device for Bowel Incontinence

Phase 4

Waitlist Available

Led By Dobie Giles, MD

Research Sponsored by University of Wisconsin, Madison

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Fecal incontinence, defined as any uncontrolled loss of liquid or solid fecal material that occurs at least monthly over the last 3 months that is bothersome enough to desire treatment

Adult, age ≥ 18 years, assigned female at birth

Must not have

Current diagnosis of colorectal or anal malignancy

Diagnosis of uncontrolled inflammatory bowel disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 16 and 24 weeks, long term follow up at 1 and 2 years

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

No Placebo-Only Group

Summary

This trial aims to answer if 8 weeks of using the Leva device is as effective as 16 weeks for treating fecal incontinence in women. Participants will use the device and fill out surveys.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort from inserting the vaginal device used by The Leva System and possible irritation. Since this system involves exercises and app usage, there might also be risks associated with incorrect usage of the device.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am an adult woman aged 18 or older.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with colorectal or anal cancer.

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My inflammatory bowel disease is not under control.

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I have a current rectovaginal fistula or cloacal defect.

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My pelvic organ prolapse is at stage 4.

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My rectum has slipped outside its normal place.

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I have had pelvic floor surgery in the last 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 16 and 24 weeks, long term follow up at 1 and 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 16 and 24 weeks, long term follow up at 1 and 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 16 and 24 weeks, long term follow up at 1 and 2 years for reporting.