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Alpha-1 Adrenergic Receptor Antagonist

Tamsulosin for Post-Operative Urinary Retention (POUR Trial)

Phase 4

Waitlist Available

Led By Feiran Lou, MD

Research Sponsored by University of Massachusetts, Worcester

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

All male patients >=60 years old who undergo inpatient thoracic surgery for major resections.

Be older than 18 years old

Must not have

Patients known to be CYP2D6 poor metabolizers

Usage of the following medications prior to surgery: strong CYP 3A4 inhibitors, strong CYP2D6 inhibitors, other alpha-adrenergic blocking agents, PDE5 inhibitors, and cimetidine

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 days

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Drug Has Already Been Approved

Summary

This trial is testing if a common medication used to treat urinary issues can help reduce the rates of post-operative urinary retention in people who are at high risk for this complication after surgery.

Who is the study for?

This trial is for male patients aged 60 or older who are undergoing inpatient thoracic surgery. They must not have severe liver failure, be on certain medications like strong CYP inhibitors, have a history of prostatectomy, end-stage kidney disease, known allergies to tamsulosin or sulfonamides, glaucoma, low blood pressure, or plans for cataract surgery soon.

What is being tested?

The study is testing if taking tamsulosin before thoracic surgery can prevent urinary retention after the operation. It's a forward-looking study where high-risk patients receive this medication as a preventative measure.

What are the potential side effects?

Tamsulosin may cause dizziness due to low blood pressure upon standing up (orthostatic hypotension), headaches, issues with ejaculation and rarely may affect eye surgery outcomes.

Eligibility Criteria

Inclusion Criteria

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

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I am a man over 60 planning to have major chest surgery as an inpatient.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am a poor metabolizer for the CYP2D6 enzyme.

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I have not taken strong medication inhibitors or specific heart and erection medications before surgery.

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I cannot take tamsulosin due to allergies, glaucoma, low blood pressure, or upcoming cataract surgery.

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My liver is severely damaged.

Select...

I have had surgery to remove my prostate or bladder.

Select...

I am on dialysis for end-stage kidney disease.

Select...

I am unable to give consent for myself.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Participants With Post-Operative Urinary Retention (Pour)

Side effects data

From 2018 Phase 4 trial • 715 Patients • NCT02757768

Headache

Hypertension

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Mirabegron

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Perioperative Tamsulosin HydrochlorideExperimental Treatment1 Intervention

Participants undergoing thoracic surgery will receive 0.4mgTamsulosin Hydrochloride orally nightly for the two nights immediately prior to surgery and the morning of surgery.

Group II: Historical ComparatorActive Control1 Intervention

Participants who underwent thoracic surgery (historical). Information about occurrence of Peri-Operative Urinary Retention in thoracic surgery patients will be obtained via retrospective chart review.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tamsulosin Hydrochloride

2018

Completed Phase 4

~1240

0 / 8Eligibility criteria met