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
|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|
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)|
|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|
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.
- Determine if bladder scanners are accurate in determining a post void residual after urogynecologic surgery [ Time Frame: Within 48 hours after surgery ]
- 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 ]
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
|Contact: Tanaz Ferzandi, MDfirstname.lastname@example.org|
|United States, Massachusetts|
|Tufts Medical Center||Recruiting|
|Boston, Massachusetts, United States, 02111|
|Contact: Tanaz Ferzandi, MD 617-636-5890 email@example.com|
|Principal Investigator:||Tanaz Ferzandi, MD||Tufts Medical Center|