Continence Pessary Versus Disposable Intravaginal Device Trial

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Female Stress Incontinence

Intervention / Treatment
-----------------
* Device: Continence Pessary
* Device: Poise Impressa (Disposable Intravaginal Device)


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Continence Pessary<br>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. | Device: Continence Pessary<br>* 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.<br>|
| Active Comparator: Disposable Intravaginal Device<br>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. | Device: Poise Impressa (Disposable Intravaginal Device)<br>* 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.<br>* Other names: Poise Impressa;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment success | Success of stress urinary incontinence treatment is defined as a response of very much better or much better on the Patient Global Impression of Improvement (PGI-I). | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in stress urinary incontinence episodes | Change in stress urinary incontinence episodes recorded on a 3-day bladder diary, comparing baseline to end of study | 4 weeks | 
| Quality of life questionnaire change scores | Questionnaire change scores (from baseline to 4 weeks) on validated questionnaires | 4 weeks | 
| Satisfaction with device | Satisfaction with device will be assessed using likert scale questionnaires assessing device satisfaction, ease of use, comfort, and likelihood of continued use. | 4 weeks | 
| Adverse events | Potential adverse events of interest include vaginal discomfort, vaginal bleeding, vaginal infection, vaginal abrasion/laceration, and urinary tract infection (UTI) | 4 weeks | 
| Cost | Cost calculations will include cost of sizing kit and devices for the disposable intravaginal device and the cost of the device, initial fitting visit and any additional clinic visits for the continence pessary. | 4 weeks |