GET A PESSARY

Do you have stress incontinence?

The Pippa Fitness Pessary Device Effectiveness and Safety Study is a clinical trial of a self-managed, non-surgical, non-prescription product intended to prevent urine leakage caused by stress urinary incontinence (SUI). Over 29 million American women have SUI, defined by Mayo Clinic's Health Library as: "Urine leaks when you exert pressure on your bladder by coughing, sneezing, laughing, exercising or lifting something heavy." Although SUI is different than urgency incontinence, some women with SUI also experience urgency or frequency.

 

You may qualify for the study if you are a female, at least 18 years old, live near a study location, consistently leak during light exercise, and have no prior vaginal surgery.​ 

 

For Ohio, please CLICK HERE to answer additional qualifying questions.

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For Alabama, please CLICK HERE to answer additional qualifying questions.

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What is a pessary?

Continence pessaries are a well-established prescription treatment for SUI. They are silicone inserts worn in the vagina to gently press the urethra, thus helping to prevent urine leakage. They do not prevent normal urination and, depending on the design, can be worn for as little as a few hours or as long as six months.

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Why participate?

If you would like to stop wearing pads or diapers without having surgery, pessary therapy might be right for you. If you participate, you could:

• Get a diagnosis

• Experience relief of symptoms

• Receive compensation for time and travel

• Get treatment and care at no cost to you

• Help advance women’s healthcare

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Who is included and represented?

SUI affects people from all walks of life, of every race and ethnicity, regardless of income, profession, or social status. When every type of woman is represented as a study participant, we can better ensure that the data is fair and accurate, and help reduce health disparities among us.

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Still have questions or concerns?

A clinical research staff member will review all study details with candidate study participants, including potential risks and benefits. The staff member will answer questions and ensure study requirements are clear. Participant safety and privacy are of the utmost importance. Participation in this clinical trial is voluntary and can be withdrawn at any time.​

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Still curious about stress urinary incontinence?

Most large healthcare provider websites offer good basic information. In addition, you might want to read up on the topic at the American Urogynecologic Society's website.

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About the study sponsor

The study is sponsored by Liv Labs Inc., also known as Liv Labs Fitness online and on social media. Liv Labs is a consumer healthtech startup based in the United States. Their mission is to provide consumers with convenient solutions for managing symptoms of urinary incontinence. The Project Director for Liv Labs is Cofounder and CEO, Melody Roberts. (Please note that there is a different company with the same name that sells hemp products.)

 

About the sponsor's product

The study seeks to show the safety and effectiveness of an investigational device that is not yet approved by the FDA for use outside of a clinical trial. The device is designed for symptom self-management at home and on-the-go. It is expected to be made available over-the-counter, which means it will be sold without a prescription.

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Study oversight

The clinical research protocol has been previewed by the U.S. Food and Drug Administration's Center for Devices and Radiological Health (FDA).

 

Although the study is not detailed publicly, it is registered with trial identifier NCT05611970 at clinicaltrials.gov.

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Study funding

This research is supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) of the National Institutes of Health under a Small Business Innovation Research grant (award number  R44HD105574). Additional product development funding has been provided by equity investors.