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Alpha-1 Blocker

Tamsulosin for Urinary Tract Infections (FOLI Trial)

Phase 3
Recruiting
Led By Shishir K Maithel, MD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Must not have
Age <50 years
Female
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 days post-surgery
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Summary

This trial is investigating how a medication called tamsulosin (Flomax) affects the occurrence of postoperative urinary retention (POUR) and catheter-associated urinary tract infections (UTI)

Who is the study for?
This trial is for older males who are undergoing surgery and will have a Foley catheter. Participants should not be able to urinate on their own within 8 hours after the catheter is removed. The study excludes those with specific medical conditions or taking certain medications that could interfere with the trial.
What is being tested?
The study tests if tamsulosin (Flomax) can reduce problems like being unable to pee (postoperative urinary retention) and bladder infections linked to catheters, compared to a control group without this medication.
What are the potential side effects?
Tamsulosin may cause dizziness, headache, sleepiness, nausea, low blood pressure upon standing up, blurry vision or difficulty ejaculating. These side effects aren't guaranteed but are possible.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am scheduled for surgery, which could be for any reason and might involve an open or minimally invasive method.
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I am a man and at least 50 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am under 50 years old.
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I am female.
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I am currently taking Tamsulosin as part of my home medication.
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I have had surgery on my prostate, bladder, ureters, or kidneys.
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My catheter will be removed the same day as my surgery.
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I am not taking daily PDE5 inhibitors.
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I will keep a nasogastric tube in place the day after surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 days post-surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 days post-surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of participants who develop postoperative urinary retention (POUR) postoperatively (efficacy).
Secondary study objectives
Number of participants with catheter-associated urinary tract infections (CAUTI)

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: TamusolinExperimental Treatment1 Intervention
Participants will receive tamsulosin postoperatively for two days.
Group II: Control GroupExperimental Treatment1 Intervention
Participants will be randomized to the standard of care, with no medication given.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tamsulosin
2002
Completed Phase 4
~16790

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor
1,701 Previous Clinical Trials
2,604,398 Total Patients Enrolled
ABRAHAM J & PHYLLIS KATZ FOUNDATIONUNKNOWN
Shishir K Maithel, MDPrincipal InvestigatorEmory University
~129 spots leftby Feb 2026
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