RecruitingPhase 1Phase 2NCT03609580

Post-operative Urinary Retention (POUR) Following Thoracic Surgery


Sponsor

Hackensack Meridian Health

Enrollment

127 participants

Start Date

May 7, 2018

Study Type

INTERVENTIONAL

Conditions

Summary

Inability to urinate a common complication that happens to many patients after a surgery, especially in men over 60 years of age who undergo surgery on their chest. Urinary retention is uncomfortable, increases anxiety, increases hospital length of stay, and leads to more procedures such as putting in a bladder catheter (Foley). This is uncomfortable, and can lead to bleeding, infection, damage to the urethra and/or bladder and bladder spasm. The goal of this study is to attempt to prevent inability to urinate by giving patients a medication called Flomax (Tamusolin) every day beginning a week before surgery. That medication relaxes the prostate. It's approved by the Food and Drug Administration (FDA) to improve urinary flow in those with enlarged prostates. It is also commonly used in patients with bladder problems due to inability to urinate who have required a Foley.


Eligibility

Sex: MALEMin Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether giving a medication called tamsulosin (Flomax) before chest surgery can prevent a common complication called post-operative urinary retention — when a patient cannot urinate on their own after surgery. **You may be eligible if...** - You are male and 50 years of age or older - You are scheduled to have minimally invasive chest surgery (such as a wedge resection, lobectomy, or related procedure) - Your surgery is more than 3 days away from the time of consent **You may NOT be eligible if...** - You are already taking tamsulosin (Flomax) or another alpha-blocker medication - You have an allergy to tamsulosin or sulfa-based drugs - You have low blood pressure (systolic below 100) - You have heart failure or serious heart valve disease - You experience dizziness when standing up (orthostatic hypotension) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTamsulosin - 1 week

The investigators hypothesize that pre-operative administration of Tamusolin (Flomax, 0.4mg/day x 1 week), with ongoing use post-operatively until normal voiding resumes, will result in a significant decrease in the incidence of POUR after a thoracic surgical procedure.

DRUGTamsulosin - 3 days

The investigators hypothesize that pre-operative administration of Tamusolin (Flomax, 0.4mg/day x 3 days), with ongoing use post-operatively until normal voiding resumes, will result in a significant decrease in the incidence of POUR after a thoracic surgical procedure.


Locations(1)

Daniel Mansour

Hackensack, New Jersey, United States

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NCT03609580


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