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.

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.

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.

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.

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.

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.

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.

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.

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

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

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

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).

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.

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

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

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.

Total of all reporting groups

Brink Scale measures pelvic floor muscle strength, scored from 1-4 in 3 areas:

• Pressure where 1 is no response and 4 is a strong squeeze
• Vertical Displacement where 1 is none and 4 is whole fingers pulled in
• Duration Contraction where 1 is no contraction and 4 is greater than 3 seconds

• Stage 1: Most distal prolapse is more than 1 cm above the hymen
• Stage 2: Most distal prolapse is between 1 cm above and 1 cm below the hymen

A measure of incontinence scored from 0 (perfect continence) to 24 (totally incontinent)

Description of stool between 1-7

• Type 1: separate hard lumps, like nuts (hard to pass)
• Type 2: sausage shaped but lumpy
• Type 3: like a sausage but with cracks on the surface
• Type 4: like a sausage or a snake, smooth and soft
• Type 5: soft blobs with clear edges, (passed easily)
• Type 6: fluffy pieces with ragged edges, a mushy stool
• Type 7: watery, no solid pieces, entirely liquid

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.

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

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

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.

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.

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.

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.

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.

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.

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

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.

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.

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

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

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

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).

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.

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

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

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.

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.

change from baseline

continuous outcome

a priori threshold 0.05

Power analysis was determined based on a 3 point improvement on the Vaizey score in both groups. With an allowable difference of 1 point between randomized groups, type I error level = 0.05, power = 0.8, and standard deviation of outcome of 4.

change from baseline in Brink Score: Pressure

continuous outcome

a prior threshold 0.05

Power analysis was determined based on a 3 point improvement on the Vaizey score in both groups. With an allowable difference of 1 point between randomized groups, type I error level = 0.05, power = 0.8, and standard deviation of outcome of 4.

change from baseline in Brink Score: Vertical Displacement

continuous outcome

a prior threshold 0.05

Power analysis was determined based on a 3 point improvement on the Vaizey score in both groups. With an allowable difference of 1 point between randomized groups, type I error level = 0.05, power = 0.8, and standard deviation of outcome of 4.

change from baseline in Brink Score: Duration Contraction

continuous outcome

a prior threshold 0.05

Power analysis was determined based on a 3 point improvement on the Vaizey score in both groups. With an allowable difference of 1 point between randomized groups, type I error level = 0.05, power = 0.8, and standard deviation of outcome of 4.

Q2. It was easy for me to learn to use the app

continuous outcome

a prior threshold 0.05

Power analysis was determined based on a 3 point improvement on the Vaizey score in both groups. With an allowable difference of 1 point between randomized groups, type I error level = 0.05, power = 0.8, and standard deviation of outcome of 4.

Q11. I would use this app again

continuous outcome

a prior threshold 0.05

Power analysis was determined based on a 3 point improvement on the Vaizey score in both groups. With an allowable difference of 1 point between randomized groups, type I error level = 0.05, power = 0.8, and standard deviation of outcome of 4.

Q12. Overall, I am satisfied with this app

continuous outcome

a prior threshold 0.05

Power analysis was determined based on a 3 point improvement on the Vaizey score in both groups. With an allowable difference of 1 point between randomized groups, type I error level = 0.05, power = 0.8, and standard deviation of outcome of 4.

Q15. The app helped me manage my health effectively

continuous outcome

a prior threshold 0.05

Power analysis was determined based on a 3 point improvement on the Vaizey score in both groups. With an allowable difference of 1 point between randomized groups, type I error level = 0.05, power = 0.8, and standard deviation of outcome of 4.