Function of Tamsulosin in Older Males Undergoing Surgery with Indwelling Catheter

Last updated: March 7, 2025
Sponsor: Emory University
Overall Status: Active - Recruiting

Phase

3

Condition

Urinary Tract Infections

Treatment

Tamsulosin

Control Group

Clinical Study ID

NCT06257576
STUDY00006810
  • Ages > 50
  • Male

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Planned for elective surgery for any reason (benign, malignant, or indeterminatelesion) with either an open or minimally invasive approach (hepatobiliary,pancreatic, and colorectal operations)

  • Male and age ≥50 years

  • Deemed physically fit for surgery

Exclusion

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 ofsymptomatic hypotension if given with tamsulosin)

Study Design

Total Participants: 212
Treatment Group(s): 2
Primary Treatment: Tamsulosin
Phase: 3
Study Start date:
February 26, 2024
Estimated Completion Date:
February 28, 2026

Study Description

All participants in this study will be males who are undergoing a planned surgery on their liver, gallbladder/biliary 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 it's known that these complications can also increase hospital charges.

Connect with a study center

  • Emory Saint Joseph's Hospital

    Atlanta, Georgia 30308
    United States

    Active - Recruiting

  • Emory University Hospital (EUH)

    Atlanta, Georgia 30322
    United States

    Active - Recruiting

  • Emory University Hospital Midtown

    Atlanta, Georgia 30308
    United States

    Active - Recruiting

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