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

NCT ID: NCT02518971

Last Updated: 2019-04-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 176 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2018-12-19

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.

Conditions

Postoperative Urinary Retention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

tamsulosin

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

Group Type: EXPERIMENTAL

Tamsulosin

Intervention Type: DRUG

0.4 mg daily

placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

one capsule daily

Interventions

Tamsulosin

0.4 mg daily

Intervention Type: DRUG

Placebo

one capsule daily

Intervention Type: DRUG

Other Intervention Names

Flomax

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

• Minimum Eligible Age: 35 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Andrew Urquhart

Associate Professor of Orthopaedic Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrew Urquhart, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan, Dept of Orthopaedic Surgery

Manuel Schubert, MD

Role: STUDY_DIRECTOR

University of Michigan, Dept of Orthopaedic Surgery

Locations

University of Michigan Health System

Ann Arbor, Michigan, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HUM00087825

Identifier Type: -

Identifier Source: org_study_id