Accuracy of Bladder Scanners in Post-operative Voiding Trials

Pelvic Floor Disorders Clinical Trial

Official title:

Accuracy of Bladder Scanners in Post-operative Voiding Trials

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03028753
• Other study ID #: 11871
• Status: Withdrawn
• Phase: N/A
• Start date: August 2016
• Est. completion date: January 2019

Study information

• Verified date: March 2020
• Source: Tufts Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pelvic Floor Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Tufts Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Tufts Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine if bladder scanners are accurate in determining a post void residual after urogynecologic surgery		Within 48 hours after surgery
Secondary	Determine if a post void residual volume measurement is needed after a back-fill voiding trial after urogynecologic surgery		Within 48 hours after surgery