Function of Tamsulosin in Older Males Undergoing Surgery With Indwelling Catheter (FOLI)

April 4, 2026 updated by: Kenneth Cardona, Emory University

Function of Tamsulosin in Older Males Undergoing Surgery With Indwelling Catheter: A Randomized Clinical 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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
87

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Emory University Hospital Midtown
      • Atlanta, Georgia, United States, 30308
        • Emory Saint Joseph's Hospital
      • Atlanta, Georgia, United States, 30322
        • Emory University Hospital (EUH)
      • Johns Creek, Georgia, United States, 30097
        • Emory Johns Creek Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Tamusolin
Participants will receive tamsulosin postoperatively for two days.
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 Names:
  • Flomax
Other: Control Group
Participants will be randomized to the standard of care, with no medication given.
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.
Other Names:
  • Standard of Care (SOC)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of participants who develop postoperative urinary retention (POUR) postoperatively (efficacy).
Time Frame: Up to 3 days post-surgery
Researchers will document the incidence of postoperative urinary retention (POUR) rate, as defined as the inability to void within 8 hours after Foley catheter removal at midnight on postoperative day 1.
Up to 3 days post-surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of participants with catheter-associated urinary tract infections (CAUTI),
Time Frame: Up to 5 days post-surgery
Participants who develop CAUUTI, defined by positive urinary analysis (UA) or bacterial culture >100,000 colony-forming units (CFUs), within the first 5 days following surgery or until hospital discharge, whichever comes first.
Up to 5 days post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Emory University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
ABRAHAM J & PHYLLIS KATZ FOUNDATION

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kenneth Cardona, MD, Emory University

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 Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 26, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 12, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 12, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 6, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 14, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00006810
  • 2025P010592 (Other Identifier: Emory Insight Humans IRB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The Research Team will share the National Surgical Quality Improvement Program (NSQIP) de-identified data upon request.

IPD Sharing Access Criteria

The Investigator will share the NSQIP de-identified data for a secondary analysis of the data upon request.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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