Pippa Pessary Study (Clinical Trial)

Status Recruiting

Clinical 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).

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05611970
Study type	Interventional
Source	Liv Labs Inc.
Contact	Melody A Roberts
Phone	630-373-1471
Email	melody@liv-labs.com
Status	Recruiting
Phase	N/A
Start date	February 13, 2023
Completion date	December 31, 2024

View Details

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