Ambulatory Pessary Trial

Ambulatory Pessary Trial as a Preoperative Method for Diagnosing Occult Stress Urinary Incontinence

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.

Study Overview

• Status: Withdrawn
• Conditions: Urinary Incontinence
• Intervention / Treatment: Device: Urodynamics; Device: Pessary

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University Langone Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Urodynamics, followed by Pessary	Device: Urodynamics; 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.; Device: Pessary; 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.
Experimental: Pessary, followed by Urodynamics	Device: Urodynamics; 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.; Device: Pessary; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medical, Epidemiological, and social Aspects of Aging (MESA) questionnaire	leakage on a voiding diary.	3 Days
Overactive bladder quality of life (QAB-Q)- short term questionnaire		3 days

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Benjamin Brucker, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2017
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: April 18, 2016
• First Submitted That Met QC Criteria: April 18, 2016
• First Posted (Estimate): April 21, 2016

Study Record Updates

• Last Update Posted (Actual): September 11, 2017
• Last Update Submitted That Met QC Criteria: September 7, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Pelvic, Urodynamic, Vaginal Wall
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis
• Other Study ID Numbers: 15-00598

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes