Urinary Catheterization, Thoracic Surgery, Thoracic Epidural Analgesia
Conditions
Keywords
Post-operative urinary retention, Tamsulosin, urinary tract infections, catheter
Brief summary
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.
Detailed description
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.
Interventions
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
DRUGPlacebos
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.
Sponsors
McMaster University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male patients greater than the age of 40 and/or with type 2 diabetes undergoing pulmonary surgery who did not undergo straight or indwelling urinary catheterization intraoperatively. OR 2. Male patients receiving a thoracic epidural analgesia undergoing pulmonary surgery who did not undergo straight or indwelling urinary catheterization intraoperatively
Exclusion criteria
1. Active treatment of Benign Prostatic Hyperplasia (BPH) 2. Hypersensitivity or allergy to tamsulosin HCL 3. Active treatment with tamsulosin or other alpha-blocker or uses of tamsulosin/ other alpha-blocker within 3 weeks of enrollment date 4. Active urinary tract infection 5. History of urological disorder specified as urethral stricture, BPH, bladder or prostate malignancy 6. History of urological surgery (Transurethral resection of the Prostate, Transurethral resection of the Bladder, Bladder suspension, prostatectomy) 7. Underlying neurological disorders resulting in impaired bladder function 8. Any known contraindication to the use of tamsulosin HCL
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of post-operative urinary retention (POUR) | 0-24 hours | Rate of POUR; defined as requiring straight or indwelling catheterization at any point in the post-operative period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of indwelling catheterization | 0-7 days | Rate of indwelling catheterization |
| Time to first catheterization | 0-24 hours | Time to first catheterization |
| Rate and number of straight catheterizations | 0-7 days | Rate and number of straight catheterizations |
| Rates of catheter complications within 30 days of catheterization | 0 to 30 days | e.g. CAUTI, Urethral Trauma, Hematuria, urethral stricture |
| Duration of hospital length of stay | 0 to 365 days | Date of admission to date of discharge |
| Treatment emergent Adverse Events | -3 days to 2 days | Treatment emergent Adverse Events as reported by the FDA (the Federal Drug Administration ) |
Contacts
Primary ContactHousne Begum, PhD
Outcome results
None listed