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ENROLLING BY INVITATION
NCT06698627
NA

Comparison of Two Over the Counter Intravaginal Devices for the Treatment of Stress Urinary Incontinence

Sponsor: Vanderbilt University Medical Center

View on ClinicalTrials.gov

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

Interventions

DEVICE

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.

DEVICE

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