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Behavioural Intervention

LEVA® Device for Bowel Incontinence

Phase 4

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 16 and 24 weeks

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 16 and 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~16 and 24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 and 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Compare effectiveness of improving fecal incontinence between 8 weeks and 16 weeks of use

Secondary outcome measures

Change in Brink Scale Score

Change in Global Pelvic Floor Symptoms

Change in Pelvic Organ Prolapse Quantification System (POP-Q)

+12 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: 8 week use of LevaExperimental Treatment1 Intervention

Group II: 16 week use of LevaActive Control1 Intervention

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor

1,189 Previous Clinical Trials

3,169,508 Total Patients Enrolled

Dobie Giles, MDPrincipal InvestigatorUniversity of Wisconsin, Madison

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the long-term utilization of Leva within FDA parameters?

"The 8 week use of Leva has been approved and, as such, is deemed safe enough to receive a score of 3."

Answered by AI

Are any new participants needed for this experiment?

"Clinicaltrials.gov attests that this medical trial, initially posted on December 1st 2023 and recently updated on November 21st 2023, is no longer recruiting participants. However, 34 other clinical trials are actively accepting enrollees at the present time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Use of the LEVA® Pelvic Health System for Fecal Incontinence

2024. "Use of the LEVA® Pelvic Health System for Fecal Incontinence". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06152224.

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