Trial Outcomes & Findings for Use of the LEVA® Pelvic Health System for Fecal Incontinence (NCT NCT06152224)

Last Updated: 2025-10-30

Results Overview

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.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE4

Target enrollment

38 participants

Primary outcome timeframe

Baseline to 16 weeks

Results posted on

2025-10-30

Participant Flow

Participant milestones

Participant milestones
Measure	8 Week Use of Leva 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.	16 Week Use of Leva 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.
Overall Study STARTED	19	19
Overall Study 8 Week Follow-up	18	18
Overall Study 16 Week Follow-up Surveys	18	18
Overall Study 16 Week Follow-up Visit	18	17
Overall Study Completed 24 Week Time Point	18	18
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	19	19

Reasons for withdrawal

Reasons for withdrawal
Measure	8 Week Use of Leva 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.	16 Week Use of Leva 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.
Overall Study Withdrawal by Subject	1	0
Overall Study Lost to Follow-up	0	1
Overall Study On Follow Up	18	18

Baseline Characteristics

Use of the LEVA® Pelvic Health System for Fecal Incontinence

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	8 Week Use of Leva n=19 Participants 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.	16 Week Use of Leva n=19 Participants 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.	Total n=38 Participants Total of all reporting groups
Pelvic Organ Prolapse (POP-Q) Stage 2	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
Vaisey Score	13.3 units on a scale STANDARD_DEVIATION 4.3 • n=5 Participants	12.5 units on a scale STANDARD_DEVIATION 4.3 • n=7 Participants	12.9 units on a scale STANDARD_DEVIATION 4.3 • n=5 Participants
Age, Continuous	65.4 years STANDARD_DEVIATION 13.7 • n=5 Participants	60.4 years STANDARD_DEVIATION 17.0 • n=7 Participants	62.9 years STANDARD_DEVIATION 15.5 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	19 Participants n=7 Participants	38 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=5 Participants	19 Participants n=7 Participants	38 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	19 Participants n=5 Participants	18 Participants n=7 Participants	37 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Brinks Score Pressure	2.0 units on a scale n=5 Participants	2.0 units on a scale n=7 Participants	2.0 units on a scale n=5 Participants
Brinks Score Vertical Displacement	1.0 units on a scale n=5 Participants	1.0 units on a scale n=7 Participants	1.0 units on a scale n=5 Participants
Brinks Score Contraction Duration	2.0 units on a scale n=5 Participants	2.0 units on a scale n=7 Participants	2.0 units on a scale n=5 Participants
Body Mass Index (BMI)	27.2 kg/m^2 STANDARD_DEVIATION 7.9 • n=5 Participants	31.5 kg/m^2 STANDARD_DEVIATION 9.4 • n=7 Participants	29.3 kg/m^2 STANDARD_DEVIATION 8.8 • n=5 Participants
Pelvic Organ Prolapse (POP-Q) Stage 1	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Bristol Stool Scale Type 1	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Bristol Stool Scale Type 2	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Bristol Stool Scale Type 3	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Bristol Stool Scale Type 4	11 Participants n=5 Participants	4 Participants n=7 Participants	15 Participants n=5 Participants
Bristol Stool Scale Type 5	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Bristol Stool Scale Type 6	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Bristol Stool Scale Type 7	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 16 weeks

Population: one participant withdrew, one participant was lost to follow up at 16 weeks

Outcome measures

Outcome measures
Measure	8 Week Use of Leva n=19 Participants 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.	16 Week Use of Leva n=19 Participants 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.	All Participants Summary data for all participants together.
Vaizey Score to Compare Effectiveness of Improving Fecal Incontinence Between 8 Weeks and 16 Weeks of Use baseline	13.3 score on a scale Standard Deviation 4.3	12.5 score on a scale Standard Deviation 4.3	—
Vaizey Score to Compare Effectiveness of Improving Fecal Incontinence Between 8 Weeks and 16 Weeks of Use 16 weeks	9.0 score on a scale Standard Deviation 5.4	7.5 score on a scale Standard Deviation 4.4	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to 16 weeks

Population: one participant withdrew, one participant was lost to follow up at 16 weeks, one participant completed 16-week surveys but did not follow up for in person visit

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.

Outcome measures

Outcome measures
Measure	8 Week Use of Leva n=19 Participants 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.	16 Week Use of Leva n=19 Participants 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.	All Participants Summary data for all participants together.
Change in Pelvic Organ Prolapse Quantification System (POP-Q) Baseline · Stage 1	9 Participants	10 Participants	—
Change in Pelvic Organ Prolapse Quantification System (POP-Q) Baseline · Stage 2	10 Participants	9 Participants	—
Change in Pelvic Organ Prolapse Quantification System (POP-Q) Baseline · Stage 3	0 Participants	0 Participants	—
Change in Pelvic Organ Prolapse Quantification System (POP-Q) 16 weeks · Stage 1	9 Participants	10 Participants	—
Change in Pelvic Organ Prolapse Quantification System (POP-Q) 16 weeks · Stage 2	8 Participants	7 Participants	—
Change in Pelvic Organ Prolapse Quantification System (POP-Q) 16 weeks · Stage 3	1 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Baseline to 16 weeks

Population: one participant withdrew, one participant was lost to follow up at 16 weeks, one participant completed 16-week surveys but did not follow up for in person visit

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.

Outcome measures

Outcome measures
Measure	8 Week Use of Leva n=19 Participants 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.	16 Week Use of Leva n=19 Participants 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.	All Participants Summary data for all participants together.
Change in Brink Scale Score: Pressure Baseline	2.0 score on a scale Interval 2.0 to 2.0	2.0 score on a scale Interval 2.0 to 3.0	—
Change in Brink Scale Score: Pressure 16 weeks	3.0 score on a scale Interval 3.0 to 3.0	4.0 score on a scale Interval 3.0 to 4.0	—

SECONDARY outcome

Timeframe: Baseline to 16 weeks

Population: one participant withdrew, one participant was lost to follow up at 16 weeks, one participant completed 16-week surveys but did not follow up for in person visit

Outcome measures

Outcome measures
Measure	8 Week Use of Leva n=19 Participants 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.	16 Week Use of Leva n=19 Participants 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.	All Participants Summary data for all participants together.
Change in Brink Scale Score: Vertical Displacement Baseline	1.0 score on a scale Interval 1.0 to 2.0	1.0 score on a scale Interval 1.0 to 2.0	—
Change in Brink Scale Score: Vertical Displacement 16 weeks	2.5 score on a scale Interval 2.0 to 4.0	4.0 score on a scale Interval 2.0 to 4.0	—

SECONDARY outcome

Timeframe: Baseline to 16 weeks

Population: one participant withdrew, one participant was lost to follow up at 16 weeks, one participant completed 16-week surveys but did not follow up for in person visit

Outcome measures

Outcome measures
Measure	8 Week Use of Leva n=19 Participants 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.	16 Week Use of Leva n=19 Participants 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.	All Participants Summary data for all participants together.
Change in Brink Scale Score: Duration Contraction Baseline	2.0 score on a scale Interval 2.0 to 3.0	2.0 score on a scale Interval 2.0 to 3.0	—
Change in Brink Scale Score: Duration Contraction 16 weeks	4.0 score on a scale Interval 3.0 to 4.0	4.0 score on a scale Interval 4.0 to 4.0	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	8 Week Use of Leva n=18 Participants 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.	16 Week Use of Leva n=18 Participants 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.	All Participants n=36 Participants Summary data for all participants together.
mHealth App Usability Questionnaire (MAUQ) Q1. The app was easy to use	6.0 score on a scale Interval 5.0 to 7.0	7.0 score on a scale Interval 6.0 to 7.0	7.0 score on a scale Interval 6.0 to 7.0
mHealth App Usability Questionnaire (MAUQ) Q2. It was easy for me to learn to use the app	7.0 score on a scale Interval 6.0 to 7.0	7.0 score on a scale Interval 7.0 to 7.0	7.0 score on a scale Interval 6.0 to 7.0
mHealth App Usability Questionnaire (MAUQ) Q11. I would use this app again	7.0 score on a scale Interval 4.0 to 7.0	7.0 score on a scale Interval 6.0 to 7.0	7.0 score on a scale Interval 5.5 to 7.0
mHealth App Usability Questionnaire (MAUQ) Q12. Overall, I am satisfied with this app	6.0 score on a scale Interval 6.0 to 7.0	7.0 score on a scale Interval 6.0 to 7.0	6.5 score on a scale Interval 6.0 to 7.0
mHealth App Usability Questionnaire (MAUQ) Q15. The app helped me manage my health effectively	6.0 score on a scale Interval 3.0 to 7.0	6.0 score on a scale Interval 5.0 to 7.0	6.0 score on a scale Interval 3.5 to 7.0

Adverse Events

8 Week Use of Leva

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

16 Week Use of Leva

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	8 Week Use of Leva n=19 participants at risk 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.	16 Week Use of Leva n=19 participants at risk 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.
Nervous system disorders Sciatic Pain	5.3% 1/19 • up to 16 weeks (for primary outcome at the time of reporting)	0.00% 0/19 • up to 16 weeks (for primary outcome at the time of reporting)
Renal and urinary disorders Pelvic Pain with Urination	5.3% 1/19 • up to 16 weeks (for primary outcome at the time of reporting)	0.00% 0/19 • up to 16 weeks (for primary outcome at the time of reporting)

Additional Information

Ushma Patel, MD

UW School of Medicine and Public Health

Phone: (608) 287-5898

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place