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

University of Michigan

Status and phase: Terminated; Phase 3

Conditions: Postoperative Urinary Retention

Treatments: Drug: Placebo; Drug: Tamsulosin

Study type: Interventional

Funder types: Other

Identifiers

NCT02518971

HUM00087825

Details and patient eligibility

About

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.

Full 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.

Enrollment: 176 patients

Sex: Male

Ages: 35+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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176 participants in 2 patient groups, including a placebo group

tamsulosin

Experimental group

Description:

0.4 mg daily for five days pre-op through post-op day one (seven total)

Treatment:

Drug: Tamsulosin

placebo

Placebo Comparator group

Description:

One capsule daily for five days pre-op through post-op day one (seven total)

Treatment:

Drug: Placebo