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Accuracy of Bladder Scanners in Post-operative Voiding Trials

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ClinicalTrials.gov Identifier: NCT03028753
Recruitment Status : Recruiting
First Posted : January 23, 2017
Last Update Posted : April 3, 2018
Sponsor:
Information provided by (Responsible Party):
Tufts Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pelvic Floor Disorders Device: Bladder scan post void residual Procedure: Straight catheter post void residual Procedure: Back fill voiding trial Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 110 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Accuracy of Bladder Scanners in Post-operative Voiding Trials
Study Start Date : August 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine


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 Name: 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.




Primary Outcome Measures :
  1. Determine if bladder scanners are accurate in determining a post void residual after urogynecologic surgery [ Time Frame: Within 48 hours after surgery ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03028753


Contacts
Contact: Tanaz Ferzandi, MD 6176365890 tferzandi@tuftsmedicalcenter.org

Locations
United States, Massachusetts
Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02111
Contact: Tanaz Ferzandi, MD    617-636-5890    tferzandi@tuftsmedicalcenter.org   
Sponsors and Collaborators
Tufts Medical Center
Investigators
Principal Investigator: Tanaz Ferzandi, MD Tufts Medical Center

Responsible Party: Tufts Medical Center
ClinicalTrials.gov Identifier: NCT03028753     History of Changes
Other Study ID Numbers: 11871
First Posted: January 23, 2017    Key Record Dates
Last Update Posted: April 3, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

Additional relevant MeSH terms:
Pelvic Floor Disorders
Pregnancy Complications