Pippa Pessary Study (Clinical Trial)

Inclusion Criteria:

• Female, ≥18 years of age

• Diagnosed with SUI by a physician using a cough stress test (positive test)

• Confirmed Pippa Fitness Pessary fit in clinic by a physician or qualified clinician (e.g., Nurse Practitioner, Registered Nurse)

• Have a >3 month history of experiencing more than 3 episodes of SUI per week

• English literacy sufficient to understand the nature of the study and sufficient toread and understand the informed consent form

• Provision of a signed and dated informed consent form

• Willingness to use the Pippa Fitness Pessary during the study and comply with studyprocedures

• Willingness to forego use of any vaginal insert (e.g.: vaginal pessaries, bladdersupports, estrogen rings, tampons, and menstrual cups) while the Pippa FitnessPessary is in place

• Willingness to cease use of any other form of urinary incontinence treatment for theduration of the study

• Willingness and ability to interact with study staff by email, phone, text messageand video conferencing software throughout study

Exclusion Criteria:

• Known urethral stricture, bladder neck contracture, spastic bladder, vesicoureteralreflux, bladder stones, and/or bladder tumors

• Concurrent bladder specific medications (including beta agonists oranticholinergics) that affect urination and the use of any other prescriptionmedication and/or over-the-counter medication and/or dietary supplements (includingherbal supplements and those taken as teas) that affect urination, except in thoseinstances where they are medically necessary and can be actively supported at astable dosage throughout the active study period

• Known prolapse beyond hymen or any POP-Q point > 0

• Known hypersensitivity to silicone rubber

• Pelvic floor surgery including anterior bladder repair and urethral slings

• Vaginal, perineal, or uterine surgery, or abortion (spontaneous or induced) withinthe past 3 months

• Any injectable treatments, or prior surgeries for incontinence

• Class III Obesity (BMI > 40.0 kg/m2)

• Currently suffering from urinary tract or vaginal infection

• Pregnant or planning to become pregnant within 3 months, or within 3 monthspostpartum

• History of Toxic Shock Syndrome or consistent symptoms

• Previously diagnosed with urge-predominant or mixed predominant urinaryincontinence, functional incontinence, incontinence due to a central or spinal cordneurological condition (such as multiple sclerosis, neurogenic bladder, Parkinson's,spina bifida), insensate incontinence, or overflow incontinence

• Screening laboratory values outside the reference range considered significant bythe investigator which might impact the safety of the participant or outcome of thestudy

• Unsuccessful fit assessment during screening

• Any other reason the investigator decides the potential participant should notparticipate in the study

• Self-reported difficulty emptying bladder

• Difficulty inserting or wearing an intra-vaginal device