Post-Operative Urinary Retention (POUR) in Thoracic Surgery Patients Receiving Prophylactic Tamsulosin

Study Overview
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Brief Summary
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Post-Operative Urinary Retention (POUR) in Thoracic Surgery is a prospective interventional study aiming to test the hypothesis that the prophylactic use of tamsulosin prior to thoracic surgery in high risk patients leads to reduce the rates of POUR.

Detailed Description
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Post-operative urinary retention (POUR) is one of the most common post-operative complications encountered by most surgical specialties. The incidence of POUR can vary from five to 70%. Post-operative urinary retention is a prevalent complication. Patients who undergo thoracic surgery have greater urinary retention rates compared to others. Data on effective methods to reduce the risk of POUR in this high-risk group are limited. All subjects who meet inclusion and exclusion criteria will be invited to participate. There will be no randomization. All will receive tamsulosin in the pre operative period.

Official Title
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Post-Operative Urinary Retention (POUR) in Thoracic Surgery Patients Receiving Prophylactic Tamsulosin

Conditions
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Thoracic Diseases, Urinary Retention

Intervention / Treatment
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* Drug: Tamsulosin Hydrochloride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All male patients >=60 years old who undergo inpatient thoracic surgery for major resections. Exclusion Criteria: - Prisoners Adults unable to consent End stage renal disease on hemodialysis Indwelling urinary catheter Child-Pugh class C hepatic failure Usage of the following medications prior to surgery: strong CYP 3A4 inhibitors, strong CYP2D6 inhibitors, other alpha-adrenergic blocking agents, PDE5 inhibitors, and cimetidine patients known to be CYP2D6 poor metabolizers History of prostatectomy or cystectomy Patients with contraindications to tamsulosin and those at high risk for side effects: hypersensitivity to tamsulosin HCl or any component of FLOMAX capsules, hypersensitivity to sulfonamides. History of known glaucoma, hypotension, plan to undergo cataract surgery in the next 2 weeks

Ages Eligible for Study
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Minimum Age: 60 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: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: All subjects that sign a study consent and meet inclusion and exclusion criteria will receive the the study drug.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Perioperative Tamsulosin Hydrochloride<br>Participants undergoing thoracic surgery will receive 0.4mgTamsulosin Hydrochloride orally nightly for the two nights immediately prior to surgery and the morning of surgery. | Drug: Tamsulosin Hydrochloride<br>* 0.4mg orally nightly for the two days immediately prior to surgery and the morning of surgery.<br>|
| No Intervention: Historical Comparator<br>Participants who underwent thoracic surgery (historical). Information about occurrence of Peri-Operative Urinary Retention in thoracic surgery patients will be obtained via retrospective chart review. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants with Post-Operative Urinary Retention (Pour) | Percentage of Participants experiencing Post-Operative Urinary Retention (POUR) following thoracic surgery | 5 days |