Management decision

This is an open label, interventional, single arm, multi-clinic study where each adult female participant with stress urinary incontinence (SUI) serves as her own control (vaginal pessary use vs. no vaginal pessary).

The overall objectives of this clinical study are to demonstrate the effectiveness and safety of the Pippa Fitness Pessary (device) when self-administered and used in a home environment. Specifically, this study will evaluate the effectiveness of the Pippa Fitness Pessary by assessing reduction in urine leakage in up to 90 women with Stress Urinary Incontinence.

Effectiveness will be assessed by percentage reduction in 1-hour pad weight gain, reduction of stress urinary incontinence episodes per day, and a quality-of-life questionnaire. The safety of the Pippa Fitness Pessary will be evaluated by assessing all adverse events, including the results of urinalysis and vaginal examination.

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 to read 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 study procedures
• Willingness to forego use of any vaginal insert (e.g.: vaginal pessaries, bladder supports, estrogen rings, tampons, and menstrual cups) while the Pippa Fitness Pessary is in place
• Willingness to cease use of any other form of urinary incontinence treatment for the duration of the study
• Willingness and ability to interact with study staff by email, phone, text message and video conferencing software throughout study

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

Women

Adverse events were collected during the time each participant was active in the study, which was designed to last 24 days.

Mild - Events require minimal or no treatment and do not interfere with the participant's daily activities. Moderate - Events result in a low level of inconvenience or concern with the therapeutic measures. Moderate events may cause some interference with functioning. Severe - Events interrupt a participant's usual daily activity and may require systemic drug therapy or other treatment. Severe events are usually potentially life-threatening or incapacitating.

Early termination led to a very small number of subjects analyzed.