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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Postoperative Urinary Retention

In brief

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.

Key facts

Study ID

NCT02518971

Run by

University of Michigan

People needed

176

Starts

2015-08-01

Expected to finish

2018-12-19

Last updated by the study team

2019-04-12

Who can join

Age: 35 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Michigan Health System — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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