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Which device works best for leakage? new study seeks answers

NCT ID NCT06698627

Symptom relief Sponsor: Vanderbilt University Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares two store-bought devices for stress urinary incontinence (leaking urine when coughing, sneezing, or exercising). About 80 women will try both devices over 20 days and report which they prefer. The goal is to see if a web-based study is practical and what factors influence device choice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

60 people

The number who actually took part.

Started

Jun 2025

Finished

Jun 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 UTI that is active * Undergoing pelvic floor physical therapy * Had vaginal surgery within the last three months

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Conditions

The condition(s) this trial relates to.

female stress incontinence Urinary Incontinence, Stress

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Stress urinary incontinence in women

Contacts and locations

Locations

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37211, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.