Accuracy of Bladder Scanners in Post-operative Voiding Trials

March 5, 2020 updated by: Tufts Medical Center
The investigators are trying to determine if using a bladder scanner (type of ultrasound) to check how much urine is left in the bladder is the same as checking that volume with a catheter (tube that goes into your bladder to drain urine). After urogynecologic surgery, the investigators perform a voiding trial. Water is put into the participant's bladder through the catheter (tube draining your bladder). The catheter is then removed and the participant is asked to empty their bladder. After that, the investigators will use the bladder scanner (ultrasound) to see how much urine is left in the participant's bladder. After the ultrasound, the investigators will pass a very small catheter (tube) into the bladder to take out the remaining urine. The investigators will then compare the amount obtained from the catheter to the ultrasound amount. This will also help the investigators to figure out if they need to check how much urine is left in a patient's bladder after the voiding trial.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

The primary aim of this study is to determine if bladder scanners are accurate in determining a post-void residual volume (PVR) after Urogynecologic surgery.

The secondary aim of this study is to determine if a post-void residual volume (PVR) measurement is needed after a back-fill voiding trial on Urogynecologic post-op patients.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Undergoing Urogynecologic surgery
  • Able to consent
  • Greater than 18 years old
  • Non pregnant

Exclusion Criteria:

  • Need for prolonged catheterization
  • Unable to consent
  • Prisoner

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: All subjects
All subjects enrolled in the study will have a back-fill voiding trial performed at the time of catheter removal after urogynecologic surgery.
Device: Bladder scan post void residual
After voiding on the commode, all subjects will have a post void residual measured by bladder scanner
Other Names:
  • Verathon BVI9400 Bladder scanner
Procedure: Straight catheter post void residual
After voiding on the commode and having a post void residual measured by bladder scanner, all subjects will have a post void residual measured by straight catheter performed with usual sterile technique.
Procedure: Back fill voiding trial
Prior to catheter removal, all subjects will undergo a back fill voiding trial. The bag of the foley catheter will be removed and the subjects bladder will be filled with 300cc of normal saline (or as much as they can tolerate). The foley catheter will then be removed and the subject will be asked to void on the commode. The voided volume will be measured.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Determine if bladder scanners are accurate in determining a post void residual after urogynecologic surgery
Time Frame: Within 48 hours after surgery
Within 48 hours after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Determine if a post void residual volume measurement is needed after a back-fill voiding trial after urogynecologic surgery
Time Frame: Within 48 hours after surgery
Within 48 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tufts Medical Center

Investigators

  • Principal Investigator: Tanaz Ferzandi, MD, Tufts Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

January 1, 2019

Study Registration Dates

First Submitted

January 11, 2017

First Submitted That Met QC Criteria

January 18, 2017

First Posted (Estimate)

January 23, 2017

Study Record Updates

Last Update Posted (Actual)

March 9, 2020

Last Update Submitted That Met QC Criteria

March 5, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11871

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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