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Preoperative Tamsulosin for Urinary Retention After Thoracic Surgery (POUR Trial)

Phase 1 & 2
Recruiting
Led By Nabil Rizk
Research Sponsored by Hackensack Meridian Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
≥50 years old Planned surgical procedure of a minimally invasive thoracic surgical procedure (wedge resection, segmentectomy, lobectomy, pleural biopsy, or pleurodesis)
Males
Must not have
Allergy to Flomax or sulfa drugs
History of prostate surgery (prostatectomy, trans-urethral resection)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 hours
Awards & highlights
No Placebo-Only Group

Summary

This trial is studying whether giving Flomax before surgery can prevent urinary retention after surgery, especially in men over 60 years of age who are having surgery on their chest.

Who is the study for?
This trial is for men over 50 who are scheduled for minimally invasive chest surgery (like lung tissue removal or pleural biopsy) in at least 3 days. It's not for those already on Flomax, with allergies to it or sulfa drugs, using certain blood pressure medications, having very low blood pressure, severe heart conditions, or a history of prostate surgery.
What is being tested?
The study tests if taking Tamsulosin (Flomax), which relaxes the prostate and improves urine flow, can prevent urinary retention when started either one week before or three days prior to thoracic surgery. The goal is to reduce complications like catheter-related issues.
What are the potential side effects?
Tamsulosin may cause dizziness due to lowered blood pressure especially when standing up quickly (orthostatic hypotension), headaches, tiredness, nausea and could potentially affect sexual function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 50 or older and scheduled for a minor chest surgery.
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I am male.
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My surgery is scheduled for more than 3 days after I give consent.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am allergic to Flomax or sulfa drugs.
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I have had surgery on my prostate.
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I am currently taking medication that affects my blood pressure or bladder.
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I have been diagnosed with congestive heart failure and valvular heart disease.
Select...
I am currently taking Flomax.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Volume of urine (cc) post thoracic surgery in patients that received Flomax, 0.4mg/day for a week before surgery

Awards & Highlights

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: 3 days Pre-operative Tamsulosin administrationExperimental Treatment1 Intervention
Group II: 1 week Pre-operative Tamsulosin administrationExperimental Treatment1 Intervention

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Hackensack Meridian HealthLead Sponsor
135 Previous Clinical Trials
30,208 Total Patients Enrolled
1 Trials studying Urinary Retention
46 Patients Enrolled for Urinary Retention
Nabil RizkPrincipal InvestigatorHackensack Meridian Health
Daniel Mansour, MDPrincipal InvestigatorHackensack Meridian Health

Media Library

1 week Pre-operative Tamsulosin administration Clinical Trial Eligibility Overview. Trial Name: NCT03609580 — Phase 1 & 2
Urinary Retention Research Study Groups: 1 week Pre-operative Tamsulosin administration, 3 days Pre-operative Tamsulosin administration
Urinary Retention Clinical Trial 2023: 1 week Pre-operative Tamsulosin administration Highlights & Side Effects. Trial Name: NCT03609580 — Phase 1 & 2
1 week Pre-operative Tamsulosin administration 2023 Treatment Timeline for Medical Study. Trial Name: NCT03609580 — Phase 1 & 2
~22 spots leftby Mar 2026
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