Function of Tamsulosin in Older Males Undergoing Surgery With Indwelling Catheter

RECRUITING

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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).

Conditions:

Postoperative Urinary Tract Infection

Study Start (Actual) 2024-02-26

Primary Completion (Estimated) 2026-02

Study Completion (Estimated) 2026-08

Enrollment (Estimated) 212

Study Type INTERVENTIONAL

Phase PHASE3

Locations:

📍 Atlanta, Georgia, United States

Eligibility Criteria

Description

Inclusion Criteria:

* Planned for elective surgery for any reason (benign, malignant, or indeterminate lesion) with either an open or minimally invasive approach (hepatobiliary, pancreatic, and colorectal operations)
* Male and age ≥50 years
* Deemed physically fit for surgery

Exclusion Criteria:

* Inability to obtain informed consent
* Age \<50 years
* Female
* Baseline creatinine \>1.5x upper limit of normal
* Tamsulosin therapy as a home-medication
* Procedure involving the prostate, bladder, ureters, or kidneys
* Planned Foley catheter removal on the same day of surgery
* Planned nasogastric tube retention on postoperative day 1
* Individuals taking daily phosphodiesterase 5 (PDE5) inhibitors (due to the risk of symptomatic hypotension if given with tamsulosin)

Ages Eligible for Study: 50 Years to N/A (ADULT, OLDER_ADULT)

Sexes Eligible for Study: MALE

Accepts Healthy Volunteers: No

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted2024-02-06
First Submitted that Met QC Criteria2024-02-06
First Posted2024-02-14

Study Record Updates

Last Update Submitted that Met QC Criteria2024-03-05
Last Update Posted2024-03-06
Last Verified2024-03