Accuracy of Bladder Scanners in Post-operative Voiding Trials

Not Applicable

Withdrawn

• Conditions: Pelvic Floor Disorders
• Interventions: Device: Bladder scan post void residual; Procedure: Straight catheter post void residual; Procedure: Back fill voiding trial

• Registration Number: NCT03028753
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2016-08
• Study First Submitted: 2017-01-11
• Study First Submitted QC: 2017-01-18
• Study First Posted: 2017-01-23
• Primary Completion: 2018-12
• Study Completion: 2019-01
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-05
• Last Update Posted: 2020-03-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All subjects	Straight catheter post void residual	All subjects enrolled in the study will have a back-fill voiding trial performed at the time of catheter removal after urogynecologic surgery.
All subjects	Back fill voiding trial	All subjects enrolled in the study will have a back-fill voiding trial performed at the time of catheter removal after urogynecologic surgery.
All subjects	Bladder scan post void residual	All subjects enrolled in the study will have a back-fill voiding trial performed at the time of catheter removal after urogynecologic surgery.

Primary Outcome Measures

Name	Time	Method
Determine if bladder scanners are accurate in determining a post void residual after urogynecologic surgery	Within 48 hours after surgery

Secondary Outcome Measures

Name	Time	Method
Determine if a post void residual volume measurement is needed after a back-fill voiding trial after urogynecologic surgery	Within 48 hours after surgery

Trial Locations

Locations (1)

Tufts Medical Center; 🇺🇸 Boston, Massachusetts, United States