NCT03174431

Continence Pessary Versus Disposable Intravaginal Device Trial

A Comparison of Continence Pessary to a Disposable Intravaginal Device in the Management of Stress Urinary Incontinence: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Ohio State University · Academic / Other
• Sex: Female
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-centered randomized controlled trial of women with stress urinary incontinence or stress predominant mixed urinary incontinence who desire non-surgical therapy.

Detailed description

In this randomized trial, eligible patients who provide written consent for participation will be enrolled. At enrollment we will collect baseline demographic data and ask participants to complete questionnaires and a 3-day bladder diary. Subjects will be randomized in a 1:1 ratio to continence pessary or disposable intravaginal device.

Conditions

• Female Stress Incontinence

Interventions

Type	Name	Description
DEVICE	Continence Pessary	Continence pessaries are inexpensive, reusable intravaginal devices made of flexible silicon that provide support to the urethra to prevent urinary leakage. Continence pessaries are fitted by trained clinicians in the office and managed by patients or their provider.
DEVICE	Poise Impressa (Disposable Intravaginal Device)	In 2014, the FDA approved an over-the-counter disposable intravaginal device as another nonsurgical treatment for SUI. This device is comprised of 4 support poles covered in a non-absorbable nylon mesh that is deployed using an intravaginal applicator.

Timeline

• Start date: 2017-08-01
• Primary completion: 2019-06-30
• Completion: 2021-06-01
• First posted: 2017-06-02
• Last updated: 2024-02-23
• Results posted: 2024-02-23

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study