Pippa Pessary Study (Clinical Trial)

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).

Study Overview

• Status: Recruiting
• Conditions: Stress Urinary Incontinence
• Intervention / Treatment: Device: Vaginal pessary

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.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Melody A Roberts; Phone Number: 630-373-1471; Email: melody@liv-labs.com
• Study Contact Backup: Name: Denise Steiner; Phone Number: ‭(224) 628-1940‬; Email: denise@liv-labs.com

Study Locations

• United States
  • Florida
    • Lake Worth, Florida, United States, 33461
      • Withdrawn
      • Altus Research
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Terminated
      • Northwestern Medicine Urogynecology and Reconstructive Surgery
    • Lake Forest, Illinois, United States, 60045
      • Terminated
      • Northwestern Medicine Urogynecology and Reconstructive Surgery
    • Winfield, Illinois, United States, 60190
      • Withdrawn
      • Northwestern Medicine Urogynecology and Reconstructive Surgery
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • The Ohio State University Medical Center (OSUMC)
      • Contact: Taryn Summerfield; Phone Number: 614-366-2506; Email: Taryn.Summerfield@osumc.edu
      • Principal Investigator: Lisa C Hickman, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Each study participant serves as her own control.	Device: Vaginal pessary; A reusable vaginal pessary for stress urinary incontinence

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Responder rate of success in reduction of urine leakage with intervention	A responder will be defined as having >50% reduction in pad weight gain for the 1-hour pad weight test with vs without the pessary and/or >50% reduction in the average daily reports of number of urine leaks per day during periods with and without the pessary.	24 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Quality of Life as measured by the Incontinence Impact Questionnaire Short Form (IIQ-7) at baseline and at the end of the treatment phase.	The IIQ-7 assesses the psychosocial impact of urinary incontinence in women, specifically physical activity, travel, social relationships and emotional health.	24 days

Collaborators and Investigators

• Sponsor: Liv Labs Inc.
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Melody A Roberts, Liv Labs Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2023
• Primary Completion (Estimated): November 18, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: November 3, 2022
• First Submitted That Met QC Criteria: November 3, 2022
• First Posted (Actual): November 10, 2022

Study Record Updates

• Last Update Posted (Actual): April 25, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: stress urinary incontinence; SUI; pelvic floor dysfunction
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: LL101; R44HD105574-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No