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

Inclusion Criteria2

  • Males
  • ≥50 years old Planned surgical procedure of a minimally invasive thoracic surgical procedure (wedge resection, segmentectomy, lobectomy, pleural biopsy, or pleurodesis) Surgery scheduled more than 3 days from the time of consent

Exclusion Criteria7

  • Using Flomax already
  • Allergy to Flomax or sulfa drugs
  • Current use of alpha blockers or alpha agonists
  • Resting systolic blood pressure \<100
  • Orthostatic hypotension of \>20mm Hg (millimeters of mercury) Systolic and/or 10mm Hg diastolic pressure from sitting to standing (after 2 minutes of standing) as measured at the time of consent
  • Known diagnosis of congestive heart failure and valvular heart disease
  • History of prostate surgery (prostatectomy, trans-urethral resection)

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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