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



Status:Terminated
Conditions:Urology
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:35 - Any
Updated:12/23/2018
Start Date:August 2015
End Date:December 19, 2018

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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

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.

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.

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
We found this trial at
1
site
1500 E Medical Center Dr
Ann Arbor, Michigan 48109
(734) 936-4000
Phone: 734-936-5780
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