Continence Pessary Versus Disposable Intravaginal Device Trial

The Ohio State University

Status: Completed

Conditions: Female Stress Incontinence

Treatments: Device: Poise Impressa (Disposable Intravaginal Device); Device: Continence Pessary

Study type: Interventional

Funder types: Other

Identifiers

NCT03174431

SUI_Continence Pessary Trial

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: Female

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Continence Pessary

Active Comparator group

Description:

Participants randomized to the continence pessary will be fitted for a pessary by a clinician at enrollment and they will be taught how to remove and reinsert the device. Per usual clinical practice they will be instructed to call with any concerns and scheduled for a return visit in 2 weeks for a follow-up to assess fit and comfort and undergo refitting if necessary.

Treatment:

Device: Continence Pessary

Disposable Intravaginal Device

Active Comparator group

Description:

Participants randomized to the intravaginal device will be given a sizing kit in the office, asked to select a size and provided with a 2-week supply of the appropriately sized devices. In accordance with manufacturer guidelines, participants will be instructed that the device is to be used for no more than 8 hours per 24-hour period and that each device is single use only. Participants will return in 2 weeks for a follow-up visit to assess fit and comfort, undergo resizing as necessary and receive an additional 2 week supply of the appropriately sized devices.

Treatment:

Device: Poise Impressa (Disposable Intravaginal Device)