Back to resultsAmbulatory Pessary Trial
Primary Purpose
Urinary Incontinence
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Urodynamics
Pessary
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Incontinence focused on measuring Pelvic, Urodynamic, Vaginal Wall
Eligibility Criteria
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
Sites / Locations
- New York University Langone Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Urodynamics, followed by Pessary
Pessary, followed by Urodynamics
Arm Description
Outcomes
Primary Outcome Measures
Medical, Epidemiological, and social Aspects of Aging (MESA) questionnaire
leakage on a voiding diary.
Overactive bladder quality of life (QAB-Q)- short term questionnaire
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02746913
Brief Title
Ambulatory Pessary Trial
Official Title
Ambulatory Pessary Trial as a Preoperative Method for Diagnosing Occult Stress Urinary Incontinence
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of funding
Study Start Date
November 2017 (Anticipated)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence
Keywords
Pelvic, Urodynamic, Vaginal Wall
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Urodynamics, followed by Pessary
Arm Type
Experimental
Arm Title
Pessary, followed by Urodynamics
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Urodynamics
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Pessary
Intervention Description
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.
Primary Outcome Measure Information:
Title
Medical, Epidemiological, and social Aspects of Aging (MESA) questionnaire
Description
leakage on a voiding diary.
Time Frame
3 Days
Title
Overactive bladder quality of life (QAB-Q)- short term questionnaire
Time Frame
3 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin Brucker, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
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Ambulatory Pessary Trial
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