NCT03028753

Accuracy of Bladder Scanners in Post-operative Voiding Trials

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Tufts Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pelvic Floor Disorders

Interventions

Type	Name	Description
DEVICE	Bladder scan post void residual	After voiding on the commode, all subjects will have a post void residual measured by 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.

Timeline

• Start date: 2016-08-01
• Primary completion: 2018-12-01
• Completion: 2019-01-01
• First posted: 2017-01-23
• Last updated: 2020-03-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study