Post Operative Urinary Retention (POUR) Following Thoracic Oncological Surgery

Study Overview
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Brief Summary
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This is a feasibility study looking at whether the use of Tamsulosin could lower the high incidence of postoperative urinary retention (POUR) in older men who undergo an oncological thoracic surgical procedure for suspected or confirmed cancer. In addition, the study will try to identify the time of resumption of presurgical urinary function post Tamsulosin administration.

Detailed Description
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Post-operative urinary retention (POUR) is a significant problem in post-operative patients. The incidence varies, but can reach up to 70%, which most commonly affects older men with enlarged prostates. Even after adjusting for the modifiable risk factors, such as decreased intraoperative foley use and post-operative narcotic use, the incidence remains high. This causes an increase in urinary tract infections, patient discomfort, longer hospital stays, and occasionally further urologic complications. Studies have shown that the use of tamsulosin, an alpha1-adrenergic receptor blocker, may decrease the incidence of POUR by improving urinary flow via relaxation of the smooth muscle tissue. Therefore, the goal of our study is to investigate whether Tamsulosin (Flomax) can be used to lower incidence of POUR in older men undergoing an oncological thoracic surgical procedure. This is a pilot/feasibility/ early efficacy study to determine if treating men > 55 years of age with Tamsulosin prior to a thoracic oncological surgery will prevent postoperative urinary retention (POUR). Subjects will be provided with a prescription for Tamsulosin (generic) to be taken 7 days prior to scheduled surgery. For research purposes, post-surgical spontaneous voids will be measured, and any residual urine in the bladder will be assessed and measured using a BladderScanner. This data will be used to determine postoperative urinary retention (POUR). Additionally, standard of care bladder management will be used if the subject did not spontaneously void or had excess urine residual. The algorithm in the table below will guide bladder management decisions.

Official Title
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Post Operative Urinary Retention (POUR) Following Thoracic Oncological Surgery

Conditions
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Urinary Retention

Intervention / Treatment
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* Drug: Tamsulosin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males ≥55 years old Planned thoracic oncological surgical procedure of a video assisted oncological surgical procedure for suspected or confirmed cancer. Surgery scheduled more than 7 days from the time of consent Exclusion Criteria: Using Tamsulosin already Known allergy to Tamsulosin or sulfa drugs Current use of Boceprevir Resting systolic blood pressure <100 Orthostatic hypotension of >20mm Hg systolic and/or 10mm Hg diastolic pressure from sitting to standing (after 2 minutes of standing) as measured at the time of consent Known history of hypotension Known diagnosis of congestive heart failure (CHF) and valvular heart disease History of prior prostate surgery (prostatectomy, trans-urethral resection)

Ages Eligible for Study
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Minimum Age: 55 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pre-operative Tamsulosin administration<br>Subjects will be provided with a prescription for Tamsulosin (generic) to be taken 7 days prior to scheduled surgery for thoracic cancer. Tamsulosin dose is set at 0.4mg/day and should be taken daily for seven days prior to their planned surgery date. Study subjects will also be given a diary to record their daily usage. Study subjects should take Tamsulosin on the day of the surgery with a sip of water. | Drug: Tamsulosin<br>* Tamsulosin 0.4 mg one time daily after a meal for seven days prior to surgery. Post-surgery, an ultrasound of the bladder will be completed approximately six hours after surgery to assess the bladder. If the bladder ultrasound shows more than 400 cc of urine in the bladder, or if the study subject passes urine on his own and there is more than 100cc or less than 400 cc of urine left in the bladder, he will be encouraged to try to pass urine. Study subject will be monitored for two additional hours. If a study subject is unable to pass urine at this time or the bladder has 400 cc or more of urine left in it, he will have an intermittent catheter (in and out) to drain urine. If the bladder has greater than 500 cc (which is approximately 16 and two-thirds ounces) per catheterization for more than 24 hours, and the study subject cannot pass urine, an indwelling catheter may be considered.<br>* Other names: Flomax;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants that were able to spontaneously void after surgery completion | Self-reported void within 6-8 hours post operative | 6-8 hours post operative | 
| Time of the void | Time (number of minutes) to first postoperative spontaneous urination post operation | Within 24 hours post operative | 
| Volume of urine | Volume of urine during the first postoperative spontaneous urination post operation. | Within 24 hours post operative | 
| Amount of residual urine | Patients will receive a bladder scan post their first postoperative spontaneous urination and the amount of residual urine will be measured. | Within 24 hours post operative | 
| Number of participants that needed an intervention due to failure to spontaneously urinate | Patients that did not spontaneously urinate within 6-8 hours post operative will have an intervention. Potential interventions include : a) Prompted voiding and rescanning in 2 hours; b) Intermittent catheterization and patient prompting; c) Indwelling catheter inserted. | Within 24 hours post operative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Urinary Retention, post surgery Urinary Retention, thoracic surgery, spontaneous voiding, bladder retention, Tamsulosin (FlomaxTM), kidney injury, men undergoing thoracic oncological surgical procedure, BladderScanner