Ambulatory Pessary Trial

NCT ID: NCT02746913

Last Updated: 2017-09-11

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-30
• Study Completion Date: 2017-12-31

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.

Conditions

Urinary Incontinence

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Urodynamics, followed by Pessary

Group Type: EXPERIMENTAL

Urodynamics

Intervention Type: DEVICE

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

Intervention Type: DEVICE

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.

Pessary, followed by Urodynamics

Group Type: EXPERIMENTAL

Urodynamics

Intervention Type: DEVICE

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

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Benjamin Brucker, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

New York University Langone Medical Center

New York, New York, United States

Countries

United States

Other Identifiers

15-00598

Identifier Type: -

Identifier Source: org_study_id