Fecal IncontinencePhase 4NCT06152224
Use of the LEVA® Pelvic Health System for Fecal Incontinence
A Phase 4 study testing The Leva Pelvic Health System in people with Fecal Incontinence, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fecal Incontinence
- What is being tested?
- The Leva Pelvic Health System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jan 2024to Dec 2026
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Duration of Use of the Leva® Pelvic Health System in Women With 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.
Read the 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.
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.
- Conditions
- Fecal Incontinence
- Being tested
- The Leva Pelvic Health System
- Keywords
- anal incontinence, accidental bowel leakage, pelvic health system
- Medical subject headings
- Fecal Incontinence, Encopresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Leva Pelvic Health SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 8 week use of Leva | Experimental | Not described Receives: Device: The Leva Pelvic Health System |
| 16 week use of Leva | Active comparator | Not described Receives: Device: The Leva Pelvic Health System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaizey Score to Compare Effectiveness of Improving Fecal Incontinence Between 8 Weeks and 16 Weeks of Use
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.
Measured: Baseline to 16 weeks
Secondary outcomes (18)
Change in Fecal Incontinence Severity
Using St. Mark's Incontinence score, score ranges from 0-24, higher scores indicate more severe symptoms.
Measured: Baseline to 16 and 24 weeks, long term follow up at 1 and 2 years
Cumulative Adherence Correlation With Change in St. Mark's Score
Adherence as a percentage of all expected exercise sessions correlated with change in St Mark's Incontinence Score (1-24)
Measured: Baseline to 24 weeks, long term follow up at 1 and 2 years
Patient Satisfaction and Usability of the Smartphone Application Component of the Leva Pelvic Health System
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.
Measured: Baseline to 16 and 24 weeks, long term follow up at 1 and 2 years
Change in Fecal Incontinence From Baseline to 24 Weeks After 8 or 16 Weeks of Treatment
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.
Measured: Baseline to 24 weeks, long term follow up at 1 and 2 years
Change in Pelvic Organ Prolapse Quantification System (POP-Q)
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.
Measured: Baseline to 16 weeks
Change in Brink Scale Score: Pressure
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.
Measured: Baseline to 16 weeks
Change in Brink Scale Score: Vertical Displacement
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.
Measured: Baseline to 16 weeks
Change in Brink Scale Score: Duration Contraction
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.
Measured: Baseline to 16 weeks
Change in Stool Consistency
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.
Measured: Baseline to 16 and 24 weeks, long term follow up at 1 and 2 years
Change in Fecal Incontinence Quality of Life (FIQoL)
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.
Measured: Baseline to 16 and 24 weeks, long term follow up at 1 and 2 years
Change in Sexual Function (PISQ-IR)
PISQ-IR is a 20 item survey, where higher scores indicate lower sexual function.
Measured: Baseline to 16 and 24 weeks, long term follow up at 1 and 2 years
Patient Global Impression of Improvement (PGI-I)
PGI-I is a 2 question qualitative survey in which participants state their satisfaction and perception of improvement.
Measured: 16 and 24 weeks, long term follow up at 1 and 2 years
Patient Satisfaction (PGI-I)
PGI-I is a 2 question qualitative survey in which participants state their satisfaction and perception of improvement.
Measured: 16 and 24 weeks, long term follow up at 1 and 2 years
Estimated Percentage of Change
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).
Measured: 16 and 24 weeks, long term follow up at 1 and 2 years
Change in Global Pelvic Floor Symptoms
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.
Measured: Baseline to 16 and 24 weeks, long term follow up at 1 and 2 years
Evaluate Self-continuation of Pelvic Floor Muscle Exercises
Participant self-report on whether and how often they continued the pelvic floor muscle exercises.
Measured: Baseline and 24 weeks, long term follow up at 1 and 2 years
Number of Cumulative Adverse Events
Systematic assessment of all adverse events over the course of the study, reported as a number of total AEs.
Measured: Baseline and 24 weeks, long term follow up at 1 and 2 years
mHealth App Usability Questionnaire (MAUQ)
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.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2023
- Study start17 Jan 2024
- Primary completion17 Dec 2024
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Fecal IncontinenceStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dobie Giles, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06152224
- Sponsor's protocol ID
- 2023-1304
- Other IDs
- A532810, Protocol Version 10/1/2024, SMPH/OBGYN BENIGN GYN
- Status last verified
- Sep 2026
- First submitted
- 21 Nov 2023
- Last updated
- 28 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Duration of Use of the Leva® Pelvic Health System in Women With Fecal Incontinence
- ClinicalTrials.gov ID
- NCT06152224
- Acronym / sponsor ID
- 2023-1304
- Conditions
- Fecal Incontinence
- Keywords
- anal incontinence, accidental bowel leakage, pelvic health system
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 17 Jan 2024 (actual)
- Primary completion
- 17 Dec 2024 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 30 Nov 2023 (actual)
- Results
- Posted 30 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 8 week use of Leva | Experimental | Device: The Leva Pelvic Health System |
| 16 week use of Leva | Active comparator | Device: The Leva Pelvic Health System |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Leva Pelvic Health SystemThe 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. | Device | 16 week use of Leva, 8 week use of Leva |
Primary outcome
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.
18 secondary outcomes
Change in Fecal Incontinence Severity
Time frame: Baseline to 16 and 24 weeks, long term follow up at 1 and 2 years
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
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
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
Change in Pelvic Organ Prolapse Quantification System (POP-Q)
Time frame: Baseline to 16 weeks
Change in Brink Scale Score: Pressure
Time frame: Baseline to 16 weeks
Change in Brink Scale Score: Vertical Displacement
Time frame: Baseline to 16 weeks
Change in Brink Scale Score: Duration Contraction
Time frame: Baseline to 16 weeks
Change in Stool Consistency
Time frame: Baseline to 16 and 24 weeks, long term follow up at 1 and 2 years
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
Change in Sexual Function (PISQ-IR)
Time frame: Baseline to 16 and 24 weeks, long term follow up at 1 and 2 years
Patient Global Impression of Improvement (PGI-I)
Time frame: 16 and 24 weeks, long term follow up at 1 and 2 years
Patient Satisfaction (PGI-I)
Time frame: 16 and 24 weeks, long term follow up at 1 and 2 years
Estimated Percentage of Change
Time frame: 16 and 24 weeks, long term follow up at 1 and 2 years
Change in Global Pelvic Floor Symptoms
Time frame: Baseline to 16 and 24 weeks, long term follow up at 1 and 2 years
Evaluate Self-continuation of Pelvic Floor Muscle Exercises
Time frame: Baseline and 24 weeks, long term follow up at 1 and 2 years
Number of Cumulative Adverse Events
Time frame: Baseline and 24 weeks, long term follow up at 1 and 2 years
mHealth App Usability Questionnaire (MAUQ)
Time frame: 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dobie Giles, MD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing The Leva Pelvic Health System in people with Fecal Incontinence, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaizey Score to Compare Effectiveness of Improving Fecal Incontinence Between 8 Weeks and 16 Weeks of Use (time frame: Baseline to 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.