CompletedNot Applicable

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

United States60 participantsStarted 2025-06-30

Plain-language 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

Who can participate

Age range

21 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Women with a history of stress urinary incontinence that have not undergone treatment that desire conservative management. Inclusion criteria: * 21 years or older * Patients will be screened for inclusion criteria using the MESA. This questionnaire helps to identify patients with mixed urinary incontinence (MUI) and help distinguish between stress predominant mixed urinary incontinence and urge predominant mixed urinary incontinence. The UUI score should be zero. We will not allow patients that have MUI to be included in the study based on the MESA. * Report an average loss of urine greater than three episodes per week. * Ability to receive mail through USPS Exclusion Criteria: * Patient should not be on vacation at time of study and should be performing daily activities. * Inability to follow packaged instructions for insertion devices chosen to be included within this study * Pregnancy or plan to become pregnant in the next three months * Significant vaginal atrophy due to genitourinary syndrome of menopause * Current use of over-the-counter vaginal insertion device for treatment of stress urinary incontinence * Post-menopausal bleeding * Participants that report visible prolapse and/or bother symptoms of prolapse * Bladder modifying medications * Unable to use incontinence device per package instructions * Given birth in the past three months * Had vaginal surgery in the last three months * IUD placement in the past 6 months * Vaginal infection or …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Device Preference

Timeframe: Day 10, Day 20

Trial details

NCT IDNCT06698627

SponsorVanderbilt University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06-01

View on ClinicalTrials.gov More Stress Urinary Incontinence in Women trials