Ambulatory Pessary Trial

NYU Langone Health logo

NYU Langone Health

Status

Withdrawn

Conditions

Urinary Incontinence

Treatments

Device: Pessary
Device: Urodynamics

Study type

Interventional

Funder types

Other

Identifiers

NCT02746913
15-00598

Details and patient eligibility

About

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.

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 2 patient groups

Urodynamics, followed by Pessary
Experimental group
Treatment:
Device: Urodynamics
Device: Pessary
Pessary, followed by Urodynamics
Experimental group
Treatment:
Device: Urodynamics
Device: Pessary

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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