Ambulatory Pessary Trial
Not Applicable
Withdrawn
- Conditions
- Urinary Incontinence
- Registration Number
- NCT02746913
- Lead Sponsor
- NYU Langone Health
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Female
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
New York University Langone Medical Center
🇺🇸New York, New York, United States
New York University Langone Medical Center🇺🇸New York, New York, United States