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

• Status: Terminated
• Trial end date: 2018-12-19
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Michigan
• Treatments: Tamsulosin

Criteria

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