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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
7
A reusable vaginal pessary for stress urinary incontinence
Northwestern Medicine Urogynecology and Reconstructive Surgery
Chicago, Illinois, United States
Northwestern Medicine Urogynecology and Reconstructive Surgery
Lake Forest, Illinois, United States
The Ohio State University Medical Center (OSUMC)
Columbus, Ohio, United States
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.
Time frame: From baseline to 24 days
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.
Time frame: 24 days
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