Trial of Prophylactic Tamsulosin for Postoperative Urinary Retention in Primary Total Hip and Knee Arthroplasty Patients

Study Overview
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Brief Summary
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The study aims to evaluate the efficacy of prophylactic tamsulosin in reducing the incidence of postoperative urinary retention in primary total knee and hip arthroplasty patients.

Detailed Description
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Prophylactic administration of tamsulosin will be compared to a placebo to evaluate the effectiveness in reducing the incidence of postoperative urinary retention in total hip and knee arthroplasty patients.

Official Title
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Prospective, Randomized, Double-Blind, Placebo-Controlled Trial of Prophylactic Tamsulosin for Postoperative Urinary Retention in Primary Total Hip and Knee Arthroplasty Patients

Conditions
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Postoperative 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: Men age 35 or older Primary total hip and knee arthroplasty patients (general, spinal, or epidural anesthesia No current use (>1 month) of alpha-blockers Community ambulator Adequate organ and marrow function as defined below: leucocytes at least 3,000/µL, absolute neutrophil count at least 1,500/µL, platelets at least 100,000/µL, creatinine within normal institutional limits Ability to understand, and the willingness to sign, a written informed consent Exclusion Criteria: History of radical prostatectomy Receiving any other investigational agents Revision hip and knee arthroplasty patients Severe liver or kidney disease Taking strong inhibitors of CYP3A4 (ketoconazole, itraconazole, clarithromycin, ritonavir, indinavir/ritonavir, lopinavir, or conivaptan) Being on alpha-blockers (alfuzosin, doxazosin, prazosin, terazosin, tamsulosin, phenoxybenzamine, or silodosin) Being of 5-alpha reductase inhibitors (finasteride, dutasteride) History of allergy or sensitivity to tamsulosin or other alpha-blockers (alfuzosin, doxazosin, prazosin, terazosin, or phenoxybenzamine) Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements Taking Sildenafil,Tadalafil, or Vardenafil

Ages Eligible for Study
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Minimum Age: 35 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tamsulosin<br>0.4 mg daily for five days pre-op through post-op day one (seven total) | Drug: Tamsulosin<br>* 0.4 mg daily<br>* Other names: Flomax;|
| Placebo Comparator: placebo<br>One capsule daily for five days pre-op through post-op day one (seven total) | Drug: Placebo<br>* one capsule daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients to Develop Postoperative Urinary Retention (POUR) | Patients who have not developed POUR will have two consecutive, spontaneous urine voids with residual volume of less than 200 mL, as determined by bladder scan or straight catheterization. Patients who do not successfully have the two spontaneous urine voids of less than 200 mL will be considered as having developed POUR. The incidence of POUR will be compared statistically between those taking and not taking tamsulosin at the time of surgery. | Postop day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Hospital Stay | Length of hospital stay will be recorded in days and compared statistically between the two groups . | 1-4 days postoperative | 
| Incidence of Discharge to a Skilled Nursing Facility | Discharge to a skilled nursing facility will be recorded (yes/no) and compared statistically between the two groups. | 1-4 days postoperative | 
| Incidence of Surgical Site Infection | Surgical site infection will be recorded (yes/no) and compared statistically between the two groups. | Up to two weeks postoperative | 
| Acute Postoperative Pain Medication Dosages | The dosages of postoperative pain medications will be compared statistically between the two groups. | Postoperative day 1 to day of discharge (1-4 days on average) | 
| Incidence of Postoperative Complications | Postoperative complications will be recorded and the incidence will be compared statistically between the two groups. | Up to 31 days postoperative |