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COMPLETED
NCT06257576
PHASE3

Function of Tamsulosin in Older Males Undergoing Surgery With Indwelling Catheter

Sponsor: Emory University

View on ClinicalTrials.gov

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).

Official title: Function of Tamsulosin in Older Males Undergoing Surgery With Indwelling Catheter: A Randomized Clinical Trial

Key Details

Gender

MALE

Age Range

50 Years - Any

Study Type

INTERVENTIONAL

Enrollment

87

Start Date

2024-02-26

Completion Date

2025-11-12

Last Updated

2026-04-09

Healthy Volunteers

No

Interventions

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 (4)

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

Emory Johns Creek Hospital

Johns Creek, Georgia, United States