RecruitingPhase 3NCT06257576

Function of Tamsulosin in Older Males Undergoing Surgery with Indwelling Catheter

Function of Tamsulosin in Older Males Undergoing Surgery with Indwelling Catheter: a Randomized Clinical Trial

Sponsor

Emory University

Enrollment

212 participants

Start Date

Feb 26, 2024

Study Type

INTERVENTIONAL

Conditions

Postoperative Urinary Tract Infection

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).

Eligibility

Sex: MALEMin Age: 50 Years

Inclusion Criteria3

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 Criteria9

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)

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Interventions

DRUGTamsulosin

Tamsulosin is a selective antagonist at alpha-1A and alpha-1B-adrenoreceptors in the prostate, prostatic capsule, prostatic urethra, and bladder neck. Blockage of the alpha-1A receptors causes relaxation of smooth muscles in the bladder neck and prostate, thus decreasing urinary outflow resistance in men. Tamsulosin will be administered twice a day for two (2) days as an oral tablet containing 0.4 mg of the drug. It is usually administered 30 minutes after a meal to minimize plasma level variations. The 0.4 mg dose of tamsulosin that will be used in this trial has shown adequate safety and tolerability in multiple previously published studies as well as efficacy in treating benign prostatic hyperplasia (BPH) and lower urinary tract symptoms in men. A Foley catheter, which will be placed for the participant's surgical procedure regardless of enrollment in the study, will be removed at midnight on postoperative day 1.

OTHERControl Group

A Foley catheter, which will be placed for the participant's surgical procedure regardless of enrollment in the study, will be removed at midnight on postoperative day 1.