Pippa Pessary Study (Clinical Trial)

NCT05611970 | Terminated Results FDA Device

• 2 other identifiers: LL101R44HD105574-02
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 3

Brief 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).

Conditions

Stress Urinary Incontinence

Keywords

stress urinary incontinence; SUI; pelvic floor dysfunction

Outcome Measures

Primary Outcomes (1)

• 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.

  From baseline to 24 days

Secondary Outcomes (1)

• Change in Quality of Life at Baseline and 24 Days

  24 days

Study Arms (1)

Intervention

EXPERIMENTAL

Each study participant serves as her own control.

Device: Vaginal pessary

Interventions

Vaginal pessary DEVICE

A reusable vaginal pessary for stress urinary incontinence

Intervention

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Liv Labs Inc.: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (3)

Northwestern Medicine Urogynecology and Reconstructive Surgery

Chicago, Illinois, 60611, United States

Location

Northwestern Medicine Urogynecology and Reconstructive Surgery

Lake Forest, Illinois, 60045, United States

Location

The Ohio State University Medical Center (OSUMC)

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Interventions

Pessaries

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Equipment; Equipment and Supplies

Limitations and Caveats

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

Results Point of Contact

• Title: Research Director
• Organization: Liv Labs Inc.

research@livlabsfitness.com

847-220-4478

Study Officials

• Melody A Roberts

  Liv Labs Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Interventional multi-clinic study where each participant serves as her own control.

Study Record Dates

• First Submitted: November 3, 2022
• First Posted: November 10, 2022
• Study Start: February 13, 2023
• Primary Completion: April 9, 2024
• Study Completion: April 9, 2024
• Last Updated: March 13, 2026
• Results First Posted: March 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)