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

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.

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.

Inclusion Criteria:

• Age 21 years or older (based on disposable intravaginal device manufacturing recommendations).
• SUI or SUI-predominant mixed incontinence
• English-speaking

Exclusion Criteria:

• Pregnancy
• Current symptomatic urinary tract infection (UTI).
• Postmenopausal bleeding of unknown etiology
• Neurogenic bladder
• Urinary retention (PVR >150mL obtained via bladder scan or catheterization)
• Pelvic organ prolapse past the hymen as assessed by POP-Q examination
• Inability to complete questionnaires in English or comply with study protocol
• Contraindication to pessary or disposable intravaginal device use or prior treatment or experience with either intervention.
• Prior surgery for stress urinary incontinence