Clinical trial NCT02518971: Trial of Prophylactic Tamsulosin for Postoperative Urinary Retention in Primary Total Hip and Knee Arthroplasty Patients
Official title: Prospective, Randomized, Double-Blind, Placebo-Controlled Trial of Prophylactic Tamsulosin for Postoperative Urinary Retention in Primary Total Hip and Knee Arthroplasty Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Postoperative Urinary Retention
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2015-08-10
Enrollment: 176
Sex: MALE
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Number of Patients to Develop Postoperative Urinary Retention (POUR)
timeFrame: Postop day 1
Secondary outcomes:
measure: Length of Hospital Stay
timeFrame: 1-4 days postoperative
measure: Incidence of Discharge to a Skilled Nursing Facility
timeFrame: 1-4 days postoperative
measure: Incidence of Surgical Site Infection
timeFrame: Up to two weeks postoperative
measure: Acute Postoperative Pain Medication Dosages
timeFrame: Postoperative day 1 to day of discharge (1-4 days on average)
measure: Incidence of Postoperative Complications
timeFrame: Up to 31 days postoperative
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
Study officials:
affiliation: University of Michigan, Dept of Orthopaedic Surgery
name: Andrew Urquhart, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan, Dept of Orthopaedic Surgery
name: Manuel Schubert, MD
role: STUDY_DIRECTOR
References: