Ambulatory Pessary Trial

Study Overview
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Brief Summary
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The purpose of this study is to compare two methods for assessing patients with pelvic organ prolapse for occult stress urinary incontinence. Urodynamic testing is the most widely accepted and well-studied method for diagnosing occult stress urinary incontinence preoperatively, but an ambulatory pessary trial is a less expensive option that is available to a wider group of practitioners and evaluates patient while they are engaged in their daily activities.

Official Title
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Ambulatory Pessary Trial as a Preoperative Method for Diagnosing Occult Stress Urinary Incontinence

Conditions
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Urinary Incontinence

Intervention / Treatment
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* Device: Urodynamics
* Device: Pessary


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female Patients planning to undergo pelvic organ prolapse surgery and preoperative urodynamic testing within 6 months of recruitment. Stage 2 or greater pelvic organ prolapse on pre op POP-Q exam Negative stress test on clinical exam Cognitive capacity to complete questionnaires and voiding diary Exclusion Criteria: Stress incontinence during provocative stress test on pre-operative exam. Occult stress urinary incontinence demonstrated on pre-operative physical exam Known ability to retain a pessary for the 3 day trial < age 18 History of bladder augmentation or artificial sphincter Known neurologic disease effecting bladder (spinal cord injury, Multiple Sclerosis, Parkinson's Disease, etc.) Non ambulatory patients Active infections of the vagina or pelvis (Pelvic inflammatory disease, infectious vaginitis, etc.) Occult stress urinary incontinence demonstrated on pre-operative physical exam Known ability to retain a pessary for the 3 day trial < age 18 History of bladder augmentation or artificial sphincter Known neurologic disease effecting bladder (spinal cord injury, Multiple Sclerosis, Parkinson's Disease, etc.) Non ambulatory patients Active infr

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Urodynamics, followed by Pessary<br> | Device: Urodynamics<br>* Urodynamics is performed with the Aquarius XT Laborie system and a fluoroscopic images are obtained with a GE OCE 9800 c-arm fluoroscopy unit. Urodynamic testing will be performed in a seated position with a pessary from the ambulatory pessary trial in place. Post residual void will be measured at the start of the urodynamics.<br>Device: Pessary<br>* A pessary is a silicone disc that is used in to support the uterus and vagina of women with vaginal prolapse. During this study, the pessary that will be used is a ring with support. This is a disc shape with a membrane stretched across the center. It is a device used in standard practice and is safe to keep in place for up to 3 months at a time. The subjects will be fit with a pessary asked to wear the pessary for 3 days.<br>|
| Experimental: Pessary, followed by Urodynamics<br> | Device: Urodynamics<br>* Urodynamics is performed with the Aquarius XT Laborie system and a fluoroscopic images are obtained with a GE OCE 9800 c-arm fluoroscopy unit. Urodynamic testing will be performed in a seated position with a pessary from the ambulatory pessary trial in place. Post residual void will be measured at the start of the urodynamics.<br>Device: Pessary<br>* A pessary is a silicone disc that is used in to support the uterus and vagina of women with vaginal prolapse. During this study, the pessary that will be used is a ring with support. This is a disc shape with a membrane stretched across the center. It is a device used in standard practice and is safe to keep in place for up to 3 months at a time. The subjects will be fit with a pessary asked to wear the pessary for 3 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medical, Epidemiological, and social Aspects of Aging (MESA) questionnaire | leakage on a voiding diary. | 3 Days | 
| Overactive bladder quality of life (QAB-Q)- short term questionnaire |  | 3 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pelvic, Urodynamic, Vaginal Wall