Pippa Pessary Study (Clinical Trial)

Exclusion Criteria

• •Known urethral stricture, bladder neck contracture, spastic bladder, vesicoureteral reflux, bladder stones, and/or bladder tumors
• •Concurrent bladder specific medications (including beta agonists or anticholinergics) that affect urination and the use of any other prescription medication and/or over-the-counter medication and/or dietary supplements (including herbal supplements and those taken as teas) that affect urination, except in those instances where they are medically necessary and can be actively supported at a stable 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) within the 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 months postpartum
• •History of Toxic Shock Syndrome or consistent symptoms
• •Previously diagnosed with urge-predominant or mixed predominant urinary incontinence, functional incontinence, incontinence due to a central or spinal cord neurological 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 by the investigator which might impact the safety of the participant or outcome of the study
• •Unsuccessful fit assessment during screening
• •Any other reason the investigator decides the potential participant should not participate in the study
• •Self-reported difficulty emptying bladder
• •Difficulty inserting or wearing an intra-vaginal device