Stress Urinary IncontinenceNCT05611970
Pippa Pessary Study (Clinical Trial)
A study testing Vaginal pessary in people with Stress Urinary Incontinence, run by Liv Labs Inc. at 3 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- Vaginal pessary
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 3 sitesUnited States
- Study dates
- 13 Feb 2023to 9 Apr 2024
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Northwestern Medicine Urogynecology and Reconstructive Surgery
Chicago, Illinois, 60611
The Ohio State University Medical Center (OSUMC)
Columbus, Ohio, 43210
Northwestern Medicine Urogynecology and Reconstructive Surgery
Lake Forest, Illinois, 60045
About this study
Official title: Pippa Fitness Pessary Device Effectiveness and Safety Study
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).
Read the detailed description
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.
- Conditions
- Stress Urinary Incontinence
- Being tested
- Vaginal pessary
- Keywords
- stress urinary incontinence, SUI, pelvic floor dysfunction
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal pessaryDevice
A reusable vaginal pessary for stress urinary incontinence
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Each study participant serves as her own control. Receives: Device: Vaginal pessary |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants With Diagnosed Stress Urinary Incontinence (SUI) Who Achieved >50% Reduction of Urine Leakage With Intervention
A composite endpoint comprising of study participants achieving >50% leak reduction with investigational device use (treatment) as compared to without investigational device use (baseline). The two components of the composite endpoint are 1) >50% reduction in pad weight gain for the International Continence Society's standardized 1-hour pad weight test, conducted once with investigational device use and once without investigational device use; and/or 2) >50% reduction in mean daily leak episodes during a participant-controlled home phase, comparing at least 7 days without investigational device use to at least 7 days with investigational device use.
Measured: From baseline to 24 days
Secondary outcomes (1)
Change in Quality of Life at Baseline and 24 Days
Change in Quality of Life as measured by the Incontinence Impact Questionnaire Short Form (IIQ-7) at baseline and after treatment. The IIQ-7 assesses the psychosocial impact of urinary incontinence in women, specifically physical activity, travel, social relationships and emotional health. A total score is calculated by taking the average score of each QoL attribute responded to (ranging from 0 to 3) and multiplying it by 33 1/3 to put it on a standardized scale of 0 to 100. Higher scores indicate a greater negative impact of incontinence on the individual's quality of life.
Measured: 24 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2022
- Study start13 Feb 2023
- Primary completion9 Apr 2024
- Study completion9 Apr 2024
Why it stopped: Management decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Interventional multi-clinic study where each participant serves as her own control.
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liv Labs Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Melody A Roberts, Principal investigator, Liv Labs Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05611970
- Sponsor's protocol ID
- LL101
- Other IDs
- R44HD105574-02
- Status last verified
- Jan 2026
- First submitted
- 3 Nov 2022
- Last updated
- 13 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No