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

NCT06698627 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-03-16

No results posted yet for this study

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

Conditions

  • Stress Urinary Incontinence in Women

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.

Sponsors & Collaborators

  • Vanderbilt University Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-30
Primary Completion
2026-05-01
Completion
2026-10-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06698627 on ClinicalTrials.gov