Urinary Incontinence
Conditions
Keywords
Pelvic, Urodynamic, Vaginal Wall
Brief summary
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.
Interventions
DEVICEUrodynamics
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.
DEVICEPessary
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.
Sponsors
NYU Langone Health
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Medical, Epidemiological, and social Aspects of Aging (MESA) questionnaire | 3 Days | leakage on a voiding diary. |
| Overactive bladder quality of life (QAB-Q)- short term questionnaire | 3 days | — |
Countries
United States
Outcome results
None listed