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Alpha-1 Blocker

Tamusolin for Urinary Tract Infection (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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 days post-surgery

Awards & highlights

FOLI Trial 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.Check my eligibility

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.See study design

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.

FOLI Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am scheduled for surgery, which could be for any reason and might involve an open or minimally invasive method.

Select...

I am a man and at least 50 years old.

FOLI Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 days post-surgery

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of participants who develop postoperative urinary retention (POUR) postoperatively (efficacy).

Secondary outcome measures

Number of participants with catheter-associated urinary tract infections (CAUTI)

FOLI 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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor

1,640 Previous Clinical Trials

2,560,445 Total Patients Enrolled

ABRAHAM J & PHYLLIS KATZ FOUNDATIONUNKNOWN

Shishir K Maithel, MDPrincipal InvestigatorEmory University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available vacancies for patient participation in this clinical trial?

"As per clinicaltrials.gov, this specific research study is not actively seeking participants. Originally listed on 2nd January 2024 and last modified on 6th February 2024, it is currently closed for recruitment. Nonetheless, there are a total of 82 trials presently enrolling patients."

Answered by AI

What are the potential risks associated with Tamusolin use in patients?

"Our team at Power rates the safety of Tamusolin as a 3 on our scale, considering this is a Phase 3 trial with data supporting both efficacy and safety from multiple iterations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Function of Tamsulosin in Older Males Undergoing Surgery With Indwelling Catheter

Shishir Kumar Maithel 2024. "Function of Tamsulosin in Older Males Undergoing Surgery With Indwelling Catheter". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06257576.

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