Use of the LEVA® Pelvic Health System for Fecal Incontinence
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 8 week use of Leva
|
Device: The Leva Pelvic Health System
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.
|
| Active Comparator: 16 week use of Leva
|
Device: The Leva Pelvic Health System
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.
|
Outcome Measures
Primary Outcome Measures
- Compare effectiveness of improving fecal incontinence between 8 weeks and 16 weeks of use [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 St Mark's (Vaizey) scores. A difference of -3 ± 4.37 is expected at 8 weeks and 16 weeks (compared to baseline), with an allowable difference of 1.
Secondary Outcome Measures
- Change in fecal incontinence severity [Baseline to 16 and 24 weeks]
Using St. Mark's Incontinence score, score ranges from 0-24, higher scores indicate more severe symptoms.
- Cumulative adherence correlation with change in St. Mark's score [Baseline to 24 weeks]
Adherence as a percentage of all expected exercise sessions correlated with change in St Mark's Incontinence Score (1-24)
- Patient satisfaction and usability of the smartphone application component of the Leva Pelvic Health System [Baseline to 16 and 24 weeks]
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.
- Change in fecal incontinence from baseline to 24 weeks after 8 or 16 weeks of treatment [Baseline to 24 weeks]
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.
- Change in Pelvic Organ Prolapse Quantification System (POP-Q) [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.
- Change in Brink Scale Score [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. Ratings are summed to obtain total scores, with a possible range of scores of 3 to 12 and higher scores indicating greater strength.
- Change in stool consistency [Baseline to 16 and 24 weeks]
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.
- Change in fecal Incontinence Quality of Life (FIQoL) [Baseline to 16 and 24 weeks]
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.
- Change in sexual function (PISQ-IR) [Baseline to 16 and 24 weeks]
PISQ-IR is a 20 item survey, where higher scores indicate lower sexual function.
- Patient Global Impression of Improvement (PGI-I) [16 and 24 weeks]
PGI-I is a 2 question qualitative survey in which participants state their satisfaction and perception of improvement.
- Patient Satisfaction (PGI-I) [16 and 24 weeks]
PGI-I is a 2 question qualitative survey in which participants state their satisfaction and perception of improvement.
- Estimated percentage of improvment [16 and 24 weeks]
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).
- Change in Global Pelvic Floor Symptoms [Baseline to 16 and 24 weeks]
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.
- Evaluate self-continuation of pelvic floor muscle exercises [Baseline and 24 weeks]
Participant self-report on whether and how often they continued the pelvic floor muscle exercises.
- Number of cumulative adverse events [Baseline and 24 weeks]
Systematic assessment of all adverse events over the course of the study, reported as a number of total AEs.
Eligibility Criteria
Criteria
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
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Able to stand to perform daily training for at least 3 minutes
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Able to speak and read English due to Leva smartphone application availability in only English at this time
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Have an email address, owns a smartphone, and can download an app
Exclusion Criteria:
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Inability to tolerate insertion of vaginal device (e.g., vaginal agenesis, vaginal stenosis, unremitting pelvic pain, within 12 weeks postpartum)
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Current diagnosis of colorectal or anal malignancy
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Diagnosis of uncontrolled inflammatory bowel disease
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Current rectovaginal fistula or cloacal defect
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Rectal prolapse (mucosal or full thickness)
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Inability to utilize smart phone technology ("app" use)
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Chronic Stool Types 6 or 7
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Fecal impaction by exam
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Stage 4 pelvic organ prolapse
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Concurrent supervised anal sphincter exercise/pelvic floor muscle training with or without biofeedback
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Presence of sacral neuromodulator
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Pelvic floor surgery (including anal sphincteroplasty) within the past 3 months
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Currently pregnant
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Wisconsin | Madison | Wisconsin | United States | 53705 |
Sponsors and Collaborators
- University of Wisconsin, Madison
Investigators
- Principal Investigator: Dobie Giles, MD, University of Wisconsin, Madison
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2023-1304
- A532810
- Protocol Version 10/12/2023
- SMPH/OBGYN BENIGN GYN