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

Completed · Not applicable

Conditions studied: Stress Urinary Incontinence in Women

In brief

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 facts

Study ID

NCT06698627

Run by

Vanderbilt University Medical Center

People needed

60

Starts

2025-06-30

Expected to finish

2026-06-01

Last updated by the study team

2026-06-23

Who can join

Age: 21 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Vanderbilt University Medical Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.