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

Conditions

• Stress Urinary Incontinence in Women

Eligibility Criteria

Sex

FEMALE

Age

21 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Daily Disposable Continence Device — 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 — DEVICE
  The Revive® is another over the counter vaginal insert for the treatment of SUI. This is a self-deployable, double-loop pessary device.

Study Details

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

Key Dates

Start date

Jun 30, 2025

Status verified

Mar 2026

Primary completion

May 1, 2026

Completion

Oct 1, 2026

Study Design

Enrollment

80 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Arms

• Active Comparator: Poise Impressa
  Participants will be asked to use Poise Impressa for 7 days based on package insert
• Active Comparator: Revive
  Participants will be asked to use Revive continence device based on package insert.

Primary Outcome Measure

Device Preference [ Time Frame: Day 10, Day 20 ]

Locations (1)

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