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Accuracy of Bladder Scanners in Post-operative Voiding Trials

Accuracy of Bladder Scanners in Post-operative Voiding Trials

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03028753
Enrollment
0
Registered
2017-01-23
Start date
2016-08-31
Completion date
2019-01-31
Last updated
2020-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Floor Disorders

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.

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.

Interventions

PROCEDUREStraight 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.

PROCEDUREBack 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.

DEVICEBladder scan post void residual

After voiding on the commode, all subjects will have a post void residual measured by bladder scanner

Sponsors

Tufts Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Determine if bladder scanners are accurate in determining a post void residual after urogynecologic surgeryWithin 48 hours after surgery

Secondary

MeasureTime frame
Determine if a post void residual volume measurement is needed after a back-fill voiding trial after urogynecologic surgeryWithin 48 hours after surgery

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026