REduction of Post-Operative Urinary Retention With Tamsulosin Versus Placebo (REPOURT- P) Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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Reduction of Post-Operative Urinary Retention With Tamsulosin Versus Placebo (REPOURT- P) Trial

Conditions
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Urinary Catheterization, Thoracic Surgery, Thoracic Epidural Analgesia

Intervention / Treatment
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* Drug: Tamsulosin Hydrochloride
* Drug: Placebos


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Male patients receiving a thoracic epidural analgesia undergoing pulmonary surgery who did not undergo straight or indwelling urinary catheterization intraoperatively Exclusion Criteria: Active treatment of Benign Prostatic Hyperplasia (BPH) Hypersensitivity or allergy to tamsulosin HCL Active treatment with tamsulosin or other alpha-blocker or uses of tamsulosin/ other alpha-blocker within 3 weeks of enrollment date Active urinary tract infection History of urological disorder specified as urethral stricture, BPH, bladder or prostate malignancy History of urological surgery (Transurethral resection of the Prostate, Transurethral resection of the Bladder, Bladder suspension, prostatectomy) Underlying neurological disorders resulting in impaired bladder function Any known contraindication to the use of tamsulosin HCL

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tamsulosin Hydrochloride (HCL)<br>Consenting patients undergoing pulmonary resection will receive a 5-day allotment of tamsulosin HCL to be started 3 days prior to their date of surgery. | Drug: Tamsulosin Hydrochloride<br>* 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<br>|
| Placebo Comparator: Placebo<br>Consenting patients undergoing pulmonary resection will receive a 5-day allotment of placebo to be started 3 days prior to their date of surgery. | Drug: Placebos<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 0-24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate and number of straight catheterizations | Rate and number of straight catheterizations | 0-7 days | 
| Rate of indwelling catheterization | Rate of indwelling catheterization | 0-7 days | 
| Time to first catheterization | Time to first catheterization | 0-24 hours | 
| Treatment emergent Adverse Events | Treatment emergent Adverse Events as reported by the FDA (the Federal Drug Administration ) | -3 days to 2 days | 
| Rates of catheter complications within 30 days of catheterization | e.g. CAUTI, Urethral Trauma, Hematuria, urethral stricture | 0 to 30 days | 
| Duration of hospital length of stay | Date of admission to date of discharge | 0 to 365 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post-operative urinary retention, Tamsulosin, urinary tract infections, catheter