Ambulatory Pessary Trial

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Withdrawn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