Postoperative Urinary Tract InfectionPhase 3FOLINCT06257576
Function of Tamsulosin in Older Males Undergoing Surgery With Indwelling Catheter
A Phase 3 study testing Tamsulosin in people with Postoperative Urinary Tract Infection, run by Emory University at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Postoperative Urinary Tract Infection
- What is being tested?
- Tamsulosin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 4 sitesUnited States
- Study dates
- 26 Feb 2024to 12 Nov 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 cannot join
- 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
Show all 9Show fewer
- 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)
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30308
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Emory University Hospital (EUH)
Atlanta, Georgia, 30322
Emory Johns Creek Hospital
Johns Creek, Georgia, 30097
About this study
Official title: 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).
Read the 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.
- Conditions
- Postoperative Urinary Tract Infection
- Being tested
- Tamsulosin, Control Group
- Keywords
- post-operative urinary retention (POUR), catheter-associated urinary tract infection (CAUTI), Flomax, Foley Catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TamsulosinDrug
Also called Flomax
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.
Control GroupOther
Also called Standard of Care (SOC)
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.
| Study group | Role | What they receive |
|---|---|---|
| Tamusolin | Experimental | Participants will receive tamsulosin postoperatively for two days. Receives: Drug: Tamsulosin |
| Control Group | Other | Participants will be randomized to the standard of care, with no medication given. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who develop postoperative urinary retention (POUR) postoperatively (efficacy).
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.
Measured: Up to 3 days post-surgery
Secondary outcomes (1)
Number of participants with catheter-associated urinary tract infections (CAUTI),
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.
Measured: Up to 5 days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start26 Feb 2024
- Primary completion12 Nov 2025
- Study completion12 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Urinary Tract InfectionStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- ABRAHAM J & PHYLLIS KATZ FOUNDATION
- Responsible party
- Principal investigator, Kenneth Cardona, Emory University
- Investigators
- Kenneth Cardona, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06257576
- Sponsor's protocol ID
- STUDY00006810
- Other IDs
- 2025P010592
- Acronym
- FOLI
- Status last verified
- Apr 2026
- First submitted
- 6 Feb 2024
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Research Team will share the National Surgical Quality Improvement Program (NSQIP) de-identified data upon request.
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Function of Tamsulosin in Older Males Undergoing Surgery With Indwelling Catheter: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06257576
- Acronym / sponsor ID
- FOLI / STUDY00006810
- Conditions
- Postoperative Urinary Tract Infection
- Keywords
- post-operative urinary retention (POUR), catheter-associated urinary tract infection (CAUTI), Flomax, Foley Catheter
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- ABRAHAM J & PHYLLIS KATZ FOUNDATION
- Study start
- 26 Feb 2024 (actual)
- Primary completion
- 12 Nov 2025 (actual)
- Study completion
- 12 Nov 2025 (actual)
- First posted
- 14 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tamusolin | Experimental | Drug: TamsulosinParticipants will receive tamsulosin postoperatively for two days. |
| Control Group | Other | Other: Control GroupParticipants will be randomized to the standard of care, with no medication given. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- Inability to obtain informed consent
- Age <50 years
- Female
- Baseline creatinine >1.5x upper limit of normal
- Tamsulosin therapy as a home-medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TamsulosinAlso: FlomaxTamsulosin 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. | Drug | Tamusolin |
| Control GroupAlso: Standard of Care (SOC)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 |
Primary outcome
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.
1 secondary outcome
Number of participants with catheter-associated urinary tract infections (CAUTI),
Time frame: Up to 5 days post-surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Individual participant dataSharing planned: Yes. The Research Team will share the National Surgical Quality Improvement Program (NSQIP) de-identified data upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth Cardona, MD principal investigator
Emory University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tamsulosin in people with Postoperative Urinary Tract Infection, run by Emory University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who develop postoperative urinary retention (POUR) postoperatively (efficacy). (time frame: Up to 3 days post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.