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RECRUITINGPhase 3INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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).

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - Inability to obtain willing to sign a consent form - 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) Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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)

Treatments Being Tested

DRUG

Tamsulosin

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.

OTHER

Control 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.

Locations (3)

Emory Saint Joseph's Hospital
Atlanta, Georgia, United States
Emory University Hospital Midtown
Atlanta, Georgia, United States
Emory University Hospital (EUH)
Atlanta, Georgia, United States