Fecal Incontinence
Conditions
Keywords
anal incontinence, accidental bowel leakage, pelvic health system
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.
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.
Interventions
DEVICEThe 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.
Sponsors
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vaizey Score to 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 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
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Adherence Correlation With Change in St. Mark's Score | 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) |
| Patient Satisfaction and Usability of the Smartphone Application Component of the Leva Pelvic Health System | 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. |
| Change in Fecal Incontinence From Baseline to 24 Weeks After 8 or 16 Weeks of Treatment | 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. |
| 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: Pressure | 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. |
| Change in Brink Scale Score: Vertical Displacement | 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. |
| Change in Brink Scale Score: Duration Contraction | 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. |
| Change in Stool Consistency | 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. |
| Change in Fecal Incontinence Severity | 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. |
| Change in Sexual Function (PISQ-IR) | 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. |
| Patient Global Impression of Improvement (PGI-I) | 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. |
| Patient Satisfaction (PGI-I) | 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. |
| Estimated Percentage of Change | 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). |
| Change in Global Pelvic Floor Symptoms | 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. |
| Evaluate Self-continuation of Pelvic Floor Muscle Exercises | 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. |
| Number of Cumulative Adverse Events | 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. |
| mHealth App Usability Questionnaire (MAUQ) | 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. |
| Change in Fecal Incontinence Quality of Life (FIQoL) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 19 |
| 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. | 19 |
| Total | 38 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | On Follow Up | 18 | 18 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Total | 8 Week Use of Leva | 16 Week Use of Leva |
|---|---|---|---|
| Age, Continuous | 62.9 years STANDARD_DEVIATION 15.5 | 65.4 years STANDARD_DEVIATION 13.7 | 60.4 years STANDARD_DEVIATION 17 |
| Body Mass Index (BMI) | 29.3 kg/m^2 STANDARD_DEVIATION 8.8 | 27.2 kg/m^2 STANDARD_DEVIATION 7.9 | 31.5 kg/m^2 STANDARD_DEVIATION 9.4 |
| Brinks Score Contraction Duration | 2.0 units on a scale | 2.0 units on a scale | 2.0 units on a scale |
| Brinks Score Pressure | 2.0 units on a scale | 2.0 units on a scale | 2.0 units on a scale |
| Brinks Score Vertical Displacement | 1.0 units on a scale | 1.0 units on a scale | 1.0 units on a scale |
| Bristol Stool Scale Type 1 | 3 Participants | 0 Participants | 3 Participants |
| Bristol Stool Scale Type 2 | 2 Participants | 1 Participants | 1 Participants |
| Bristol Stool Scale Type 3 | 3 Participants | 0 Participants | 3 Participants |
| Bristol Stool Scale Type 4 | 15 Participants | 11 Participants | 4 Participants |
| Bristol Stool Scale Type 5 | 7 Participants | 4 Participants | 3 Participants |
| Bristol Stool Scale Type 6 | 8 Participants | 3 Participants | 5 Participants |
| Bristol Stool Scale Type 7 | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 38 Participants | 19 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Pelvic Organ Prolapse (POP-Q) Stage 1 | 19 Participants | 9 Participants | 10 Participants |
| Pelvic Organ Prolapse (POP-Q) Stage 2 | 19 Participants | 10 Participants | 9 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 37 Participants | 19 Participants | 18 Participants |
| Sex: Female, Male Female | 38 Participants | 19 Participants | 19 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Vaisey Score | 12.9 units on a scale STANDARD_DEVIATION 4.3 | 13.3 units on a scale STANDARD_DEVIATION 4.3 | 12.5 units on a scale STANDARD_DEVIATION 4.3 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 19 |
| other Total, other adverse events | 2 / 19 | 0 / 19 |
| serious Total, serious adverse events | 0 / 19 | 0 / 19 |
Outcome results
Primary
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.
Time frame: Baseline to 16 weeks
Population: one participant withdrew, one participant was lost to follow up at 16 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 8 Week Use of Leva | 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 |
| 8 Week Use of Leva | 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 |
| 16 Week Use of Leva | Vaizey Score to Compare Effectiveness of Improving Fecal Incontinence Between 8 Weeks and 16 Weeks of Use | baseline | 12.5 score on a scale | Standard Deviation 4.3 |
| 16 Week Use of Leva | Vaizey Score to Compare Effectiveness of Improving Fecal Incontinence Between 8 Weeks and 16 Weeks of Use | 16 weeks | 7.5 score on a scale | Standard Deviation 4.4 |
Comparison: change from baselinep-value: 0.918t-test, 2 sided
Secondary
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.
Time frame: 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
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| 8 Week Use of Leva | Change in Brink Scale Score: Duration Contraction | Baseline | 2.0 score on a scale |
| 8 Week Use of Leva | Change in Brink Scale Score: Duration Contraction | 16 weeks | 4.0 score on a scale |
| 16 Week Use of Leva | Change in Brink Scale Score: Duration Contraction | Baseline | 2.0 score on a scale |
| 16 Week Use of Leva | Change in Brink Scale Score: Duration Contraction | 16 weeks | 4.0 score on a scale |
Comparison: change from baseline in Brink Score: Duration Contractionp-value: <0.001t-test, 2 sided
Comparison: change from baseline in Brink Score: Duration Contractionp-value: <0.001t-test, 2 sided
Secondary
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.
Time frame: 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
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| 8 Week Use of Leva | Change in Brink Scale Score: Pressure | Baseline | 2.0 score on a scale |
| 8 Week Use of Leva | Change in Brink Scale Score: Pressure | 16 weeks | 3.0 score on a scale |
| 16 Week Use of Leva | Change in Brink Scale Score: Pressure | Baseline | 2.0 score on a scale |
| 16 Week Use of Leva | Change in Brink Scale Score: Pressure | 16 weeks | 4.0 score on a scale |
Comparison: change from baseline Brink Score: Pressurep-value: <0.001t-test, 2 sided
Comparison: change from baseline in Brink Score: Pressurep-value: <0.001t-test, 2 sided
Secondary
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.
Time frame: 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
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| 8 Week Use of Leva | Change in Brink Scale Score: Vertical Displacement | Baseline | 1.0 score on a scale |
| 8 Week Use of Leva | Change in Brink Scale Score: Vertical Displacement | 16 weeks | 2.5 score on a scale |
| 16 Week Use of Leva | Change in Brink Scale Score: Vertical Displacement | Baseline | 1.0 score on a scale |
| 16 Week Use of Leva | Change in Brink Scale Score: Vertical Displacement | 16 weeks | 4.0 score on a scale |
Comparison: Change from baseline in Brink Score: Vertical Displacementp-value: <0.001t-test, 2 sided
Comparison: change from baseline in Brink Score: Vertical Displacementp-value: <0.001t-test, 2 sided
Secondary
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.
Time frame: Baseline to 24 weeks, long term follow up at 1 and 2 years
Secondary
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.
Time frame: Baseline to 16 and 24 weeks, long term follow up at 1 and 2 years
Secondary
Change in Fecal Incontinence Severity
Using St. Mark's Incontinence score, score ranges from 0-24, higher scores indicate more severe symptoms.
Time frame: Baseline to 16 and 24 weeks, long term follow up at 1 and 2 years
Secondary
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.
Time frame: Baseline to 16 and 24 weeks, long term follow up at 1 and 2 years
Secondary
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.
Time frame: 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
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| 8 Week Use of Leva | Change in Pelvic Organ Prolapse Quantification System (POP-Q) | Baseline | Stage 1 | 9 Participants |
| 8 Week Use of Leva | Change in Pelvic Organ Prolapse Quantification System (POP-Q) | Baseline | Stage 2 | 10 Participants |
| 8 Week Use of Leva | Change in Pelvic Organ Prolapse Quantification System (POP-Q) | Baseline | Stage 3 | 0 Participants |
| 8 Week Use of Leva | Change in Pelvic Organ Prolapse Quantification System (POP-Q) | 16 weeks | Stage 1 | 9 Participants |
| 8 Week Use of Leva | Change in Pelvic Organ Prolapse Quantification System (POP-Q) | 16 weeks | Stage 2 | 8 Participants |
| 8 Week Use of Leva | Change in Pelvic Organ Prolapse Quantification System (POP-Q) | 16 weeks | Stage 3 | 1 Participants |
| 16 Week Use of Leva | Change in Pelvic Organ Prolapse Quantification System (POP-Q) | 16 weeks | Stage 2 | 7 Participants |
| 16 Week Use of Leva | Change in Pelvic Organ Prolapse Quantification System (POP-Q) | Baseline | Stage 1 | 10 Participants |
| 16 Week Use of Leva | Change in Pelvic Organ Prolapse Quantification System (POP-Q) | 16 weeks | Stage 1 | 10 Participants |
| 16 Week Use of Leva | Change in Pelvic Organ Prolapse Quantification System (POP-Q) | Baseline | Stage 2 | 9 Participants |
| 16 Week Use of Leva | Change in Pelvic Organ Prolapse Quantification System (POP-Q) | 16 weeks | Stage 3 | 0 Participants |
| 16 Week Use of Leva | Change in Pelvic Organ Prolapse Quantification System (POP-Q) | Baseline | Stage 3 | 0 Participants |
Comparison: change from baselinep-value: 0.801t-test, 2 sided
Comparison: change from baselinep-value: 0.317t-test, 2 sided
Secondary
Change in Sexual Function (PISQ-IR)
PISQ-IR is a 20 item survey, where higher scores indicate lower sexual function.
Time frame: Baseline to 16 and 24 weeks, long term follow up at 1 and 2 years
Secondary
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.
Time frame: Baseline to 16 and 24 weeks, long term follow up at 1 and 2 years
Secondary
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)
Time frame: Baseline to 24 weeks, long term follow up at 1 and 2 years
Secondary
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).
Time frame: 16 and 24 weeks, long term follow up at 1 and 2 years
Secondary
Evaluate Self-continuation of Pelvic Floor Muscle Exercises
Participant self-report on whether and how often they continued the pelvic floor muscle exercises.
Time frame: Baseline and 24 weeks, long term follow up at 1 and 2 years
Secondary
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.
Time frame: 16 weeks
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| 8 Week Use of Leva | mHealth App Usability Questionnaire (MAUQ) | Q12. Overall, I am satisfied with this app | 6.0 score on a scale |
| 8 Week Use of Leva | mHealth App Usability Questionnaire (MAUQ) | Q11. I would use this app again | 7.0 score on a scale |
| 8 Week Use of Leva | mHealth App Usability Questionnaire (MAUQ) | Q1. The app was easy to use | 6.0 score on a scale |
| 8 Week Use of Leva | mHealth App Usability Questionnaire (MAUQ) | Q2. It was easy for me to learn to use the app | 7.0 score on a scale |
| 8 Week Use of Leva | mHealth App Usability Questionnaire (MAUQ) | Q15. The app helped me manage my health effectively | 6.0 score on a scale |
| 16 Week Use of Leva | mHealth App Usability Questionnaire (MAUQ) | Q11. I would use this app again | 7.0 score on a scale |
| 16 Week Use of Leva | mHealth App Usability Questionnaire (MAUQ) | Q1. The app was easy to use | 7.0 score on a scale |
| 16 Week Use of Leva | mHealth App Usability Questionnaire (MAUQ) | Q2. It was easy for me to learn to use the app | 7.0 score on a scale |
| 16 Week Use of Leva | mHealth App Usability Questionnaire (MAUQ) | Q12. Overall, I am satisfied with this app | 7.0 score on a scale |
| 16 Week Use of Leva | mHealth App Usability Questionnaire (MAUQ) | Q15. The app helped me manage my health effectively | 6.0 score on a scale |
| All Participants | mHealth App Usability Questionnaire (MAUQ) | Q15. The app helped me manage my health effectively | 6.0 score on a scale |
| All Participants | mHealth App Usability Questionnaire (MAUQ) | Q12. Overall, I am satisfied with this app | 6.5 score on a scale |
| All Participants | mHealth App Usability Questionnaire (MAUQ) | Q1. The app was easy to use | 7.0 score on a scale |
| All Participants | mHealth App Usability Questionnaire (MAUQ) | Q11. I would use this app again | 7.0 score on a scale |
| All Participants | mHealth App Usability Questionnaire (MAUQ) | Q2. It was easy for me to learn to use the app | 7.0 score on a scale |
Comparison: Q1. The app was easy to usep-value: 0.035t-test, 2 sided
Comparison: Q2. It was easy for me to learn to use the appp-value: 0.063t-test, 2 sided
Comparison: Q11. I would use this app againp-value: 0.587t-test, 2 sided
Comparison: Q12. Overall, I am satisfied with this appp-value: 0.107t-test, 2 sided
Comparison: Q15. The app helped me manage my health effectivelyp-value: 0.486t-test, 2 sided
Secondary
Number of Cumulative Adverse Events
Systematic assessment of all adverse events over the course of the study, reported as a number of total AEs.
Time frame: Baseline and 24 weeks, long term follow up at 1 and 2 years
Secondary
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.
Time frame: 16 and 24 weeks, long term follow up at 1 and 2 years
Secondary
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.
Time frame: Baseline to 16 and 24 weeks, long term follow up at 1 and 2 years
Secondary
Patient Satisfaction (PGI-I)
PGI-I is a 2 question qualitative survey in which participants state their satisfaction and perception of improvement.
Time frame: 16 and 24 weeks, long term follow up at 1 and 2 years