Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06257576
Status:
RECRUITING
Last Update Posted:
2024-03-06
First Post:
2024-02-06
Brief Title:
Function of Tamsulosin in Older Males Undergoing Surgery With Indwelling Catheter
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Function of Tamsulosin in Older Males Undergoing Surgery With Indwelling Catheter A Randomized Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FOLI
Brief Summary:
This study is being done to answer the question What is the impact of a medication called tamsulosin also called Flomax on the rate of postoperative urinary retention POUR and catheter-associated urinary tract infection UTI One of the most common complications following surgery and associated with Foley catheters is post-operative urinary retention POUR after the catheter is removed This is defined as being unable to urinate spontaneously within 8 hours following the removal of the indwelling Foley catheter the catheter that sits in your bladder to drain urine after surgery When this happens it requires intermittent straight catheterization of the bladder placing a temporary catheter in the bladder to drain the buildup of urine which can cause a lot of discomfort and anxiety as well as increase the risk of catheter-associated urinary tract infection CAUTI
Detailed Description:
All participants in this study will be males who are undergoing a planned surgery on their liver gallbladderbiliary tract pancreas colon or rectum for any reason If able to obtain appropriate consent from a legal representative cognitively impaired patients may be included After having surgery where a catheter is placed in the bladder to drain urine this is called a Foley indwelling catheter the catheter eventually gets removed and some of the most frequent problems that can happen after that are post-operative urinary retention POUR and catheter-associated urinary tract infection CAUTI
The goal of this study is to see if a medicine called tamsulosin also called Flomax can decrease the rate of POUR which means not being able to urinate spontaneously like normal and CAUTI which means an infection in the urinary tract This study is important because POUR and CAUTI can cause harm to patients including discomfort if a temporary catheter has to be placed back in the bladder to get the urine out infection anxiety and stress and its known that these complications can also increase hospital charges
The goal of this study is to see if a medicine called tamsulosin also called Flomax can decrease the rate of POUR which means not being able to urinate spontaneously like normal and CAUTI which means an infection in the urinary tract This study is important because POUR and CAUTI can cause harm to patients including discomfort if a temporary catheter has to be placed back in the bladder to get the urine out infection anxiety and stress and its known that these complications can also increase hospital charges
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None