At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
IMPRIVE Pilot Study: Comparison of Two Over the Counter Intravaginal Devices for the Treatment of Stress Urinary Incontinence
In Brief
A clinical study evaluating Daily Disposable Continence Device and Monthly Disposable Continence Device for Stress Urinary Incontinence in Women. Completed, enrolled 60 participants across 1 site.
Detailed 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
Study Details
Timeline
Arms & Interventions
Participants will be asked to use Poise Impressa for 7 days based on package insert
Participants will be asked to use Revive continence device based on package insert.
Interventions
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.
The Revive® is another over the counter vaginal insert for the treatment of SUI. This is a self-deployable, double-loop pessary device.