Ambulatory Pessary Trial

Not Applicable

Withdrawn

• Conditions: Urinary Incontinence
• Interventions: Device: Urodynamics; Device: Pessary

• 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

Study Timeline

• Study First Submitted: 2016-04-18
• Study First Submitted QC: 2016-04-18
• Study First Posted: 2016-04-21
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-07
• Last Update Posted: 2017-09-11
• Study Start: 2017-11
• Primary Completion: 2017-12
• Study Completion: 2017-12

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• Status: WITHDRAWN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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pessary, followed by Urodynamics	Urodynamics	-
Pessary, followed by Urodynamics	Pessary	-
Urodynamics, followed by Pessary	Urodynamics	-
Urodynamics, followed by Pessary	Pessary	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

New York University Langone Medical Center; 🇺🇸 New York, New York, United States