Ambulatory Pessary Trial

NYU Langone Health

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Urinary Incontinence

Interventions

UrodynamicsDEVICE

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.

PessaryDEVICE

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

New York University Langone Medical Center

New York, New York, United States

Outcomes

Primary Outcomes

Medical, Epidemiological, and social Aspects of Aging (MESA) questionnaire

leakage on a voiding diary.

Time frame: 3 Days

Overactive bladder quality of life (QAB-Q)- short term questionnaire

Time frame: 3 days

Data from ClinicalTrials.gov

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