Comparing Use of a Digital Health System of Pelvic Floor Exercise Program to Kegel Exercises in Stress Urinary Incontinence

A randomized controlled trial for patients with stress urinary incontinence or
stress-dominant mixed incontinence.Subjects will be randomized to 8-weeks of home kegel
exercises or 8 weeks of pelvic floor muscle exercises using the leva digital pelvic health
system that includes visual biofeedback via smartphone. Leva subjects will perform guided
pelvic floor muscle exercises for 2 1/2 minutes twice daily. Home kegel subjects will perform
kegel exercises three times daily. Following 8-weeks of training, subjects will be permitted
to continue the exercises or pursue additional therapies as indicated. Subjects randomized to
the leva digital health system will be further randomized to receive automated reminders for
the remainder of one year, or no additional reminders.

Inclusion Criteria:

- Capable of giving informed consent.

- Self-reported stress-type UI symptoms of >= three months duration

- Diagnosis of stress predominant urinary incontinence based on MESA stress symptom
score greater than MESA urge symptom score (percent of total possible urge score).

- UDI-6 score >/= 25

- Willing to participate in the 8-week study with follow up at 6-and 12-months,
refraining from the pursuit of treatment for Stress Urinary Incontinence using other
modalities (i.e. will not wear a pessary, participate in pelvic floor PT or surgery)
during the first 8- weeks.

Exclusion Criteria:

- Absence of a vagina.

- Age <18 years.

- Stage 3-4 pelvic organ prolapse (as determined by POP-Q).

- Diagnosis of any neuromuscular disease.

- Non-ambulatory.

- Currently pregnant or <12 months post-partum.

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- Previous pelvic floor muscle training (PFMT) within the last 12 months under a
supervised therapeutic plan of care.

- Currently taking, or has taken within the last 2 months, medication to treat urinary
incontinence.

- Prior augmentation cystoplasty or artificial sphincter.

- Implanted nerve stimulator for urinary symptoms.

- Participation in another clinical study within 30 days of screening.

- Impaired cognitive function.

- Contraindication to the use of a vaginal probe.

- Unable to understand instructions on the use of the leva® Plus Pelvic Digital Health
System.

- Unable to actively recruit the pelvic floor muscles to any degree for attempted
volitional contraction.