Intravaginal Devices for Bladder Leakage

(IMPRIVE Trial)

Overseen By Ukpebo R Omosigho, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

Must not be taking: Bladder modifying medications

Disqualifiers: Pregnancy, Vaginal atrophy, Prolapse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores which of two over-the-counter devices women prefer for managing stress urinary incontinence, the accidental leakage of urine during activities like sneezing or exercise. It also aims to identify factors influencing this preference and assess the feasibility of conducting such a study online. Participants will test each device—the Daily Disposable Continence Device and the Monthly Disposable Continence Device—for a short period and provide feedback. Women who experience urine leakage at least three times a week and seek a non-surgical treatment option might be suitable for this trial. As an unphased trial, this study allows participants to contribute to research that could enhance non-surgical treatment options for stress urinary incontinence.

Will I have to stop taking my current medications?

If you are taking bladder modifying medications, you will need to stop them to participate in this trial.

What prior data suggests that these intravaginal devices are safe for treating bladder leakage?

Previous studies have shown that the Revive continence device helps prevent light bladder leaks in women with stress urinary incontinence. The FDA has approved the device, confirming its safety and effectiveness. Users report it provides up to 12 hours of comfortable protection.

Research indicates that Poise Impressa is a safe option for managing stress urinary incontinence. It is designed to stop bladder leaks before they occur. Described as a comfortable alternative to incontinence pads, the product moves with the body and offers discreet protection.

Both devices are available over-the-counter, suggesting they are generally well-tolerated by users. The available data for both devices show no major safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for bladder leakage because they offer innovative and user-friendly options. Unlike traditional pads or medication, the Daily and Monthly Disposable Continence Devices are intravaginal devices designed to provide mechanical support to prevent leaks. The Revive device is notable for its reusable nature and monthly disposal, which could be more convenient and cost-effective in the long run. Meanwhile, the Poise Impressa offers a daily disposable option, allowing users to manage leakage with a fresh device every day. These devices aim to enhance comfort and discretion while providing a simple, non-surgical alternative to current treatments.

What evidence suggests that these intravaginal devices are effective for stress urinary incontinence?

Studies have shown that the Revive continence device, available to participants in this trial, can significantly reduce episodes of urinary incontinence. In one study, 78.4% of users experienced at least a 50% decrease in urine leakage. This device is a safe and effective way to manage stress urinary incontinence (SUI), which occurs when activities like coughing or exercising cause urine to leak.

Similarly, the Poise Impressa device, another option in this trial, has also proven effective. About 52% of users experienced a similar reduction in leakage, with many achieving even better results. Impressa is designed to prevent leaks before they start, offering a discreet alternative to pads. Both devices provide effective support for managing bladder leaks in different ways. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for women over 21 with stress urinary incontinence who haven't had treatment and want non-invasive options. They should have regular urine leakage, be able to get mail, and not have mixed urinary symptoms according to the MESA questionnaire.

Inclusion Criteria

I can receive mail via USPS.

I do not have mixed urinary incontinence according to the MESA questionnaire.

I experience urine loss more than three times a week.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment - Revive Device

Participants use the Revive device and complete various questionnaires and diaries

1 week

Daily self-reporting

Washout Period

Three-day washout period with no incontinence device used

3 days

Treatment - Impressa Device

Participants use the Impressa device and complete various questionnaires and diaries

1 week

Daily self-reporting

Follow-up

Participants are monitored for continued use and satisfaction with the devices

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Daily Disposable Continence Device
• Monthly Disposable Continence Device

Trial Overview The study compares two over-the-counter intravaginal devices designed for stress urinary incontinence. Women will use each device for a set period and report their preferences through an online survey, including daily bladder diaries.

How Is the Trial Designed?

Group I: Revive Active Control 1 Intervention

Participants will be asked to use Revive continence device based on package insert.

Group II: Poise Impressa Active Control 1 Intervention

Participants will be asked to use Poise Impressa for 7 days based on package insert

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06698627

Comparison of Two Over the Counter Intravaginal Devices ... The results from a series of scenarios suggest that 60.9% of time, participants will prefer Impressa over Revive (by comparing the 5-lever likert scale), with a ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7720247/

Safety and Efficacy of a Disposable Vaginal Device for ... The percentage of participants that achieved greater than 50% reduction in leakage episodes per day was 52% (n = 25 participants). The responder analysis was ...

3. poise.com poise.com/en-us/products/impressa

Impressa® Bladder Supports for Women Helps stop bladder leaks before they happen · Discreet alternative to incontinence pads · Soft-Flex Core designed to move with your body.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S000293780800135X

Efficacy and safety of a novel disposable intravaginal ... Eighty-five percent of them achieved a ≥ 70% reduction in PWG (P = .01). Improvements in overall quality of life, subjective perception of incontinence, and ...

5. mayoclinicproceedings.org mayoclinicproceedings.org/article/S0025-6196(24)00324-0/fulltext

Evaluation and Management of Female Stress Urinary ... A randomized trial comparing continence pessary to continence device (Poise Impressa®) for stress incontinence. Int Urogynecol J. 2022; 33 ...

6. poise.com poise.com/en-us/products/impressa/faq

Impressa® Frequently Asked Questions (FAQ) Are Poise® Impressa® bladder supports safe? Yes ... Impressa® Bladder Supports are designed specifically for women with Stress Urinary Incontinence ...

7. hsastore.com hsastore.com/poise-impressa-incontinence-bladder-support-for-women-bladder-control-21-ct./27055m.html?srsltid=AfmBOoph7vA0vyLKVL6H04fXbGen0vnjpHW3zfH567V74BmfclZyTOiC

Poise Impressa Incontinence Bladder Support for Women ... Poise Impressa Bladder Supports are a comfortable alternative to incontinence pads for women that protects you from bladder leaks before they happen.

8. fsastore.com fsastore.com/poise-impressa-incontinence-bladder-support-for-women-bladder-control-21-ct./27055m.html?srsltid=AfmBOoqkmA3Q_N4IjYbEJXwLHvGUA_A9KiMY6TeL5tl21TBg1PUVoP1N

Poise Impressa Incontinence Bladder Support for Women, ... Poise Impressa Bladder Supports are a comfortable alternative to incontinence pads for women that protects you from bladder leaks before they happen.