Ambulatory Pessary Trial

Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02746913
• Other study ID #: 15-00598
• Status: Withdrawn
• Phase: N/A
• First received: April 18, 2016
• Last updated: September 7, 2017
• Start date: November 2017
• Est. completion date: December 2017

Study information

• Verified date: September 2017
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	New York University Langone Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

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