NCT02746913

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 21, 2016

Completed
1.5 years until next milestone

Study Start

First participant enrolled

November 1, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

September 11, 2017

Status Verified

September 1, 2017

Enrollment Period

1 month

First QC Date

April 18, 2016

Last Update Submit

September 7, 2017

Conditions

Urinary Incontinence

Keywords

Pelvic, Urodynamic, Vaginal Wall

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Urodynamics, followed by Pessary

EXPERIMENTAL
Device: UrodynamicsDevice: Pessary

Pessary, followed by Urodynamics

EXPERIMENTAL
Device: UrodynamicsDevice: Pessary

Interventions

UrodynamicsDEVICE

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, followed by UrodynamicsUrodynamics, followed by Pessary
PessaryDEVICE

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 UrodynamicsUrodynamics, followed by Pessary

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University Langone Medical Center

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Urinary Incontinence

Interventions

Pessaries

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical EquipmentEquipment and Supplies

Study Officials

  • Benjamin Brucker, MD

    NYU Langone Health

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2016

First Posted

April 21, 2016

Study Start

November 1, 2017

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

September 11, 2017

Record last verified: 2017-09

Locations

US(1)