The purpose of this study are to determine the efficacy of tamsulosin compared to placebo in reducing post-operative urinary retention and improving other clinical outcomes in people undergoing thoracic surgery.
Post-operative urinary retention (POUR) is not an uncommon complication following thoracic surgery. It has been reported to occur in up to 12-67% of patients with the use of thoracic epidural analgesia1. Risk factors associated with urinary retention in thoracic patients include male, age over 40 years, type 2 diabetes, undergoing lung resection and the use of thoracic epidural analgesia2. Patients who experience urinary retention are treated with a straight catheter and may subsequently require the placement of an indwelling catheter. The use of these catheters is associated with numerous complications. The best studied complications are infectious and include catheter associated urinary tract infections (CAUTIs). However, many patients continue to experience symptoms well after their catheters have been removed. Tamsulosin is an alpha one adrenergic receptor blocked that is indicated for the treatment of lower urinary tract symptoms in the context of benign prostatic hyperplasia. However, it is often used in clinical practice to treat other pathologies such as acute urinary retention and nephrolithiasis. The objectives of this study are to determine the efficacy of tamsulosin compared to placebo in reducing post-operative urinary retention and catheter related complications in people undergoing thoracic surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
350
Tamsulosin HCL is an alpha blocker. It relaxes the muscles in the prostate and bladder neck, making easier to urinate. The dosage used will be 0.4 mg (administered once daily) Other names: Flomax
Half of the patients will be assigned to receive placebo tablets in the same manner as the active intervention. These tablets will have no effect.
Rate of post-operative urinary retention (POUR)
Rate of POUR; defined as requiring straight or indwelling catheterization at any point in the post-operative period.
Time frame: 0-24 hours
Rate and number of straight catheterizations
Rate and number of straight catheterizations
Time frame: 0-7 days
Rate of indwelling catheterization
Rate of indwelling catheterization
Time frame: 0-7 days
Time to first catheterization
Time to first catheterization
Time frame: 0-24 hours
Treatment emergent Adverse Events
Treatment emergent Adverse Events as reported by the FDA (the Federal Drug Administration )
Time frame: -3 days to 2 days
Rates of catheter complications within 30 days of catheterization
e.g. CAUTI, Urethral Trauma, Hematuria, urethral stricture
Time frame: 0 to 30 days
Duration of hospital length of stay
Date of admission to date of discharge
Time frame: 0 to 365 days
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