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NCT Number: NCT06152224

Use of the LEVA® Pelvic Health System for Fecal Incontinence

The goal of this clinical trial is to learn about how the duration of use of The Leva Pelvic Health System® affects treatment of fecal incontinence in women. The main question it aims to answer is to test whether use of the The Leva Pelvic Health System® for 8 weeks is as good as using it for 16 weeks.

Participants will complete surveys, and use the Leva device.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Fecal Incontinence Behavior Behavioral Symptoms Digestive System Diseases Elimination Disorders Encopresis Gastrointestinal Diseases Intestinal Diseases Mental Disorders Pathological Conditions, Signs and Symptoms Rectal Diseases Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University of Wisconsin

Madison, Wisconsin, 53705, United States

About this study

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 incontinence (symptoms >/= 3 months) in adults with a vagina. Participants will be instructed to complete pelvic floor muscle training using the Leva for 8 or 16 weeks.

The hypothesis is that 8 weeks of use of Leva is non-inferior to 16 weeks of use, assessed by a validated FI symptom severity survey. Surveys will be completed at 0 weeks, 16 weeks, and 24 weeks. Long-term surveys will be completed at 1 year and 2 years from enrollment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult, age ≥ 18years, assigned female at birth
  • 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
  • Able to stand to perform daily training for at least 3 minutes
  • Able to speak and read English due to Leva smartphone application availability in only English at this time
  • Have an email address, owns a smartphone, and can download an app

Exclusion criteria

  • Inability to tolerate insertion of vaginal device (e.g., vaginal agenesis, vaginal stenosis, unremitting pelvic pain, within 12 weeks postpartum)
  • Current diagnosis of colorectal or anal malignancy
  • Diagnosis of uncontrolled inflammatory bowel disease
  • Current rectovaginal fistula or cloacal defect
  • Rectal prolapse (mucosal or full thickness)
  • Inability to utilize smart phone technology ("app" use)
  • Chronic Stool Types 6 or 7
  • Fecal impaction by exam
  • Stage 4 pelvic organ prolapse
  • Concurrent supervised anal sphincter exercise/pelvic floor muscle training with or without biofeedback
  • Presence of sacral neuromodulator
  • Pelvic floor surgery (including anal sphincteroplasty) within the past 3 months
  • Currently pregnant

Treatment and study plan

The Leva Pelvic Health System

Device

The Leva Pelvic Health System includes an intra-vaginal device that pairs with a smartphone application to provide real-time visual feedback about pelvic floor muscle performance during usage.

Primary outcomes

  1. Vaizey Score to Compare Effectiveness of Improving Fecal Incontinence Between 8 Weeks and 16 Weeks of Use

    Time frame: Baseline to 16 weeks

    Treatment response as length of use on symptom improvement at 16 weeks (comparing 8 weeks vs 16 weeks of use of Leva) as assessed by Vaizey Score, score ranges from 0-24, higher scores indicate more severe symptoms. A difference of -4.3 ± 3 is expected at 8 weeks and 16 weeks (compared to baseline), with an allowable difference of 1.

Secondary outcomes

  1. Change in Fecal Incontinence Severity

    Time frame: Baseline to 16 and 24 weeks, long term follow up at 1 and 2 years

    Using St. Mark's Incontinence score, score ranges from 0-24, higher scores indicate more severe symptoms.

  2. Cumulative Adherence Correlation With Change in St. Mark's Score

    Time frame: Baseline to 24 weeks, long term follow up at 1 and 2 years

    Adherence as a percentage of all expected exercise sessions correlated with change in St Mark's Incontinence Score (1-24)

  3. Patient Satisfaction and Usability of the Smartphone Application Component of the Leva Pelvic Health System

    Time frame: Baseline to 16 and 24 weeks, long term follow up at 1 and 2 years

    Measured through the mHealth App Usability Questionnaire. In this questionnaire, 1 - strongly disagree, 2 - disagree, 3 - somewhat disagree, 4 - neither agree nor disagree, 5 - somewhat agree, 6 - agree, 7 - strongly agree. To determine the usability of an app, calculate the total and determine the average of the responses to all statements. The higher the overall average, the higher the usability of the app.

  4. Change in Fecal Incontinence From Baseline to 24 Weeks After 8 or 16 Weeks of Treatment

    Time frame: Baseline to 24 weeks, long term follow up at 1 and 2 years

    Treatment response as length of use on symptom improvement at 24 weeks (comparing 8 weeks vs 16 weeks of use of Leva) as assessed by St Mark's (Vaizey) scores.

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

    Time frame: Baseline to 16 weeks

    The POP-Q system is an objective, site-specific system used to describe, quantify, and stage pelvic support. Measurements are rated as Stage 0-Stage 4, with Stage 4 being complete prolapse.

  6. Change in Brink Scale Score: Pressure

    Time frame: Baseline to 16 weeks

    The Brink scale evaluates 3 PFM contraction variables: vaginal pressure or muscle force, elevation or vertical displacement of the examiner's fingers, and duration of contraction. Each muscle contraction variable is rated on a 4-point ordinal scale (1-4). Higher scores indicating greater strength.

  7. Change in Brink Scale Score: Vertical Displacement

    Time frame: Baseline to 16 weeks

    The Brink scale evaluates 3 PFM contraction variables: vaginal pressure or muscle force, elevation or vertical displacement of the examiner's fingers, and duration of contraction. Each muscle contraction variable is rated on a 4-point ordinal scale (1-4). Higher scores indicating greater strength.

  8. Change in Brink Scale Score: Duration Contraction

    Time frame: Baseline to 16 weeks

    The Brink scale evaluates 3 PFM contraction variables: vaginal pressure or muscle force, elevation or vertical displacement of the examiner's fingers, and duration of contraction. Each muscle contraction variable is rated on a 4-point ordinal scale (1-4). Higher scores indicating greater strength.

  9. Change in Stool Consistency

    Time frame: Baseline to 16 and 24 weeks, long term follow up at 1 and 2 years

    Use the Bristol Stool Scale to evaluate stool consistency. Ranges from Type 1 to Type 7, where Type 1 is hardest consistency and Type 7 is entirely liquid.

  10. Change in Fecal Incontinence Quality of Life (FIQoL)

    Time frame: Baseline to 16 and 24 weeks, long term follow up at 1 and 2 years

    Use FIQoL scale, in which participants rate questions about how often an issue is a concern, and how much they agree with statements on a scale of 1-5. Higher scores indicate lower quality of life.

  11. Change in Sexual Function (PISQ-IR)

    Time frame: Baseline to 16 and 24 weeks, long term follow up at 1 and 2 years

    PISQ-IR is a 20 item survey, where higher scores indicate lower sexual function.

  12. Patient Global Impression of Improvement (PGI-I)

    Time frame: 16 and 24 weeks, long term follow up at 1 and 2 years

    PGI-I is a 2 question qualitative survey in which participants state their satisfaction and perception of improvement.

  13. Patient Satisfaction (PGI-I)

    Time frame: 16 and 24 weeks, long term follow up at 1 and 2 years

    PGI-I is a 2 question qualitative survey in which participants state their satisfaction and perception of improvement.

  14. Estimated Percentage of Change

    Time frame: 16 and 24 weeks, long term follow up at 1 and 2 years

    Qualitative question in which participants state their estimate of how much better they are, on a scale from 0% (no better) to 100% (completely better).

  15. Change in Global Pelvic Floor Symptoms

    Time frame: Baseline to 16 and 24 weeks, long term follow up at 1 and 2 years

    Use the Pelvic Floor Distress Inventory (PFDI-20) to evaluate change in pelvic floor symptoms. It is a 20 item survey with a range from 0-100 where higher scores indicate greater symptoms.

  16. Evaluate Self-continuation of Pelvic Floor Muscle Exercises

    Time frame: Baseline and 24 weeks, long term follow up at 1 and 2 years

    Participant self-report on whether and how often they continued the pelvic floor muscle exercises.

  17. Number of Cumulative Adverse Events

    Time frame: Baseline and 24 weeks, long term follow up at 1 and 2 years

    Systematic assessment of all adverse events over the course of the study, reported as a number of total AEs.

  18. mHealth App Usability Questionnaire (MAUQ)

    Time frame: 16 weeks

    MAUQ is an 18-item survey scored on a 7 point likert scale from 1 (disagree) to 7 (agree) with higher scores indicative of higher usability.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study title

Comparison of the Duration of Use of the Leva® Pelvic Health System in Women With Fecal Incontinence

Important dates

Study start
2024
Primary completion
2024
Study completion
2026
First posted
Nov 30, 2023
Registry last updated
Oct 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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