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

Phase 3

Terminated

Conditions: Postoperative Urinary Retention

Interventions: Drug: Tamsulosin
Drug: Placebo

Registration Number: NCT02518971

Lead Sponsor: University of Michigan

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: TERMINATED

Sex: Male

Target Recruitment: 176

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
tamsulosin	Tamsulosin	0.4 mg daily for five days pre-op through post-op day one (seven total)
placebo	Placebo	One capsule daily for five days pre-op through post-op day one (seven total)

Primary Outcome Measures

Name	Time	Method
Number of Patients to Develop Postoperative Urinary Retention (POUR)	Postop day 1	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.

Secondary Outcome Measures

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