RecruitingPhase 1 / Phase 2

Post-operative Urinary Retention (POUR) Following Thoracic Surgery

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
50 Years and older
Sex
Male only
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 60 years

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether taking Flomax daily, starting one week before chest surgery, can prevent trouble peeing after surgery. Flomax relaxes the prostate to help urine flow. The study is for men age 50 or older having certain chest surgeries through small cuts.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are male and age 50 or older.
  • You plan to have chest surgery through small cuts to remove part of a lung, take a sample of the lung lining, or seal the space around a lung.
  • Your surgery is scheduled more than 3 days after you agree to join the study.

Who can't join

  • You already take Flomax.
  • You are allergic to Flomax or sulfa drugs.
  • You take medicines called alpha blockers or alpha agonists.
  • Your top blood pressure number is below 100 while resting.
  • When you stand up from sitting, your blood pressure drops by more than 20 in the top number or 10 in the bottom number. This is checked after 2 minutes of standing when you agree to join.
  • You have been diagnosed with congestive heart failure (the heart does not pump well) and heart valve disease.
  • You have had surgery to remove all or part of your prostate.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 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 Criteria: * 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)

Study sites (1)

NJ