Decreasing Rates of Intraurethral Catheterization Postoperatively in Spine Surgery

Study Overview
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Brief Summary
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Randomization (1:1) of male patients, over age 50, undergoing elective spine surgery to tamsulosin versus a placebo.

Detailed Description
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Postoperative urinary retention (POUR) is a common complication following certain surgical operations. While much is known about the innervation and neural regulation of bladder emptying and storage, the cause of urinary retention after surgery is not fully understood. Early research has indicated that a small dose of tamsulosin (Flomax®), a commonly used medication approved to treat urinary symptoms in men with benign prostatic hypertrophy, may reduce the incidence of POUR. Urinary retention is a prevalent issue in patients undergoing spinal surgery, leading to patient discomfort and prolonged length of stay. We hypothesize that the use of perioperative tamsulosin in patients undergoing spinal surgery will decrease the incidence of POUR. The study is a prospective, double-blind, randomized, placebo-controlled trial. Subjects will be randomized 1:1 to receive either oral tamsulosin 0.4 mg or placebo, taken once each evening, beginning 5 days prior to surgery and continuing through the first postoperative day. The primary endpoint is met when the patient is able to spontaneously empty their bladder post-operatively, or needs to be catheterized with either a straight or indwelling urinary catheter for post-operative urinary retention, whichever occurs first.

Official Title
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Decreasing Rates of Intraurethral Catheterization Postoperatively in Spine Surgery

Conditions
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Post-operative Urinary Retention

Intervention / Treatment
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* Drug: Tamsulosin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Male patient age 50 - 85 years Undergoing elective spine surgery at least 5 days after enrollment Preop visit done at office practice Exclusion Criteria: Currently on tamsulosin or other alpha-adrenergic blocking drug Allergy to tamsulosin Allergy to lactose Serious or life-threatening allergy to sulfa drugs Emergent procedure History of spinal trauma, spinal infection or spinal cord tumor Pre-existing indwelling urinary catheter History of orthostatic hypotension or current orthostatic hypotension History of prostate, urethral or bladder surgery Renal failure Non-English speaking Unable to provide informed consent

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tamsulosin<br>Subjects in this arm will receive tamsulosin 0.4 mg/day for five days prior to surgery and two days after surgery. | Drug: Tamsulosin<br>* Active drug<br>* Other names: Urimax;|
| Placebo Comparator: Placebo<br>Subjects in this arm will receive a placebo capsule identical in appearance to the tamsulosin capsule, for five days prior to surgery and two days after surgery. | Drug: Placebo<br>* Lactose-filled capsules identical to active drug<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients Who Undergo Postoperative Catheterization for Urinary Retention | Postoperative urinary retention was defined as the need for any postoperative urinary catheterization for acute retention. Per hospital protocol, failure to void 6 hours after surgery or development of bladder discomfort required bladder scan. If bladder volume exceeded 300 cc, catheterization was performed. | Within 2 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Stay | Length of hospital stay | 0-7 days after surgery | 
| Number of Participants With or Without Postoperative Urinary Retention Based on Preoperative Post-void Residual | Was post-void residual greater than 50 cc when measured at the preoperative office visit associated with postoperative urinary retention? | Within 2 days after surgery |