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Comparison of Two Over the Counter Intravaginal Devices for the Treatment of Stress Urinary Incontinence
Sponsor: Vanderbilt University Medical Center
Summary
The goal of this pilot study is to compare two commercially available over the counter devices for treatment of stress urinary incontinence in a web based format. The main questions it aims to answer 1. What device do women with SUI prefer after using both devices 2. What patient factors help drive this preference if any 3. Is a web-based crossover intervention study feasible Participants will: Use two over the counter devices over a course of 20 days. They will have both devices sent via mail. They will answer questions prior to the start of using any device and then after using each device They will be asked to complete daily bladder diaries
Official title: IMPRIVE Pilot Study: Comparison of Two Over the Counter Intravaginal Devices for the Treatment of Stress Urinary Incontinence
Key Details
Gender
FEMALE
Age Range
21 Years - Any
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2025-06-30
Completion Date
2026-10-01
Last Updated
2026-03-16
Healthy Volunteers
No
Conditions
Interventions
Daily Disposable Continence Device
The Poise® Impressa® is an over-the-counter intravaginal device for women over the age of 21 years with SUI. It is a disposable, one-time use tampon-like device that comprises a core, cover, and applicator. The device is inserted and removed like a vaginal tampon and comes in three sizes.
Monthly Disposable Continence Device
The Revive® is another over the counter vaginal insert for the treatment of SUI. This is a self-deployable, double-loop pessary device.
Locations (1)
Vanderbilt University Medical Center
Nashville, Tennessee, United States