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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 hours
Awards & highlights
POUR Trial 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.Check my eligibility
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.See study design
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.
POUR Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 50 or older and scheduled for a minor chest surgery.
Select...
I am male.
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My surgery is scheduled for more than 3 days after I give consent.
POUR Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Volume of urine (cc) post thoracic surgery in patients that received Flomax, 0.4mg/day for a week before surgery
POUR 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
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Hackensack Meridian HealthLead Sponsor
131 Previous Clinical Trials
28,117 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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am allergic to Flomax or sulfa drugs.Your blood pressure when you're not moving around is less than 100.I have had surgery on my prostate.I am 50 or older and scheduled for a minor chest surgery.Your blood pressure drops significantly when you stand up after sitting for a few minutes.I am currently taking medication that affects my blood pressure or bladder.I am male.I have been diagnosed with congestive heart failure and valvular heart disease.I am currently taking Flomax.My surgery is scheduled for more than 3 days after I give consent.
Research Study Groups:
This trial has the following groups:- Group 1: 1 week Pre-operative Tamsulosin administration
- Group 2: 3 days Pre-operative Tamsulosin administration
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are patients being actively sought for this experiment?
"Yes, this information is accurate according to the clinicaltrials.gov website. The listing for this study was first created on May 7th, 2018 and updated September 13th, 2022."
Answered by AI
How many patients are allowed to enroll in this trial?
"Yes, this study is still looking for participants according to the most recent update on clinicaltrials.gov from September 13th, 2022. The trial was originally posted on May 7th, 2018 and was last updated on September 13th, 2020. They are currently recruiting for 127 patients at 1 site."
Answered by AI
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