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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tamsulosin Hydrochloride (HCL) | Experimental | 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. |
|
| Placebo | Placebo Comparator | Consenting patients undergoing pulmonary resection will receive a 5-day allotment of placebo to be started 3 days prior to their date of surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tamsulosin Hydrochloride | Drug | 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 |
| 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 |
| 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 |
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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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Housne Begum, PhD | Contact | (905)522-1155 | 35338 | begumh@mcmaster.ca |
| Name | Affiliation | Role |
|---|---|---|
| Yaron Shargall, MD, PhD | McMaster University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26897642 | Background | Yeung JH, Gates S, Naidu BV, Wilson MJ, Gao Smith F. Paravertebral block versus thoracic epidural for patients undergoing thoracotomy. Cochrane Database Syst Rev. 2016 Feb 21;2(2):CD009121. doi: 10.1002/14651858.CD009121.pub2. | |
| 25564576 | Background | Kim KW, Lee JI, Kim JS, Lee YJ, Choi WJ, Jung H, Park KY, Park CH, Son KH. Risk factors for urinary retention following minor thoracic surgery. Interact Cardiovasc Thorac Surg. 2015 Apr;20(4):486-92. doi: 10.1093/icvts/ivu445. Epub 2015 Jan 6. |
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| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D000077409 | Tamsulosin |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| Placebos | Drug | 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. |
|
| 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 |
| 29971436 | Background | Saint S, Trautner BW, Fowler KE, Colozzi J, Ratz D, Lescinskas E, Hollingsworth JM, Krein SL. A Multicenter Study of Patient-Reported Infectious and Noninfectious Complications Associated With Indwelling Urethral Catheters. JAMA Intern Med. 2018 Aug 1;178(8):1078-1085. doi: 10.1001/jamainternmed.2018.2417. |
| 30984702 | Background | Shokrpour M, Shakiba E, Sirous A, Kamali A. Evaluation the efficacy of prophylactic tamsulosin in preventing acute urinary retention and other obstructive urinary symptoms following colporrhaphy surgery. J Family Med Prim Care. 2019 Feb;8(2):722-727. doi: 10.4103/jfmpc.jfmpc_18_19. |
| 28584678 | Background | Basheer A, Alsaidi M, Schultz L, Chedid M, Abdulhak M, Seyfried D. Preventive effect of tamsulosin on postoperative urinary retention in neurosurgical patients. Surg Neurol Int. 2017 May 10;8:75. doi: 10.4103/sni.sni_5_17. eCollection 2017. |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |