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

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.

Study Overview

• Status: Terminated
• Conditions: Postoperative Urinary Retention
• Intervention / Treatment: Drug: Tamsulosin; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 176
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: tamsulosin; 0.4 mg daily for five days pre-op through post-op day one (seven total)	Drug: Tamsulosin; 0.4 mg daily; Other Names: Flomax
Placebo Comparator: placebo; One capsule daily for five days pre-op through post-op day one (seven total)	Drug: Placebo; one capsule daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients to Develop Postoperative Urinary Retention (POUR)	Patients who have not developed POUR will have two consecutive, spontaneous urine voids with residual volume of less than 200 mL, as determined by bladder scan or straight catheterization. Patients who do not successfully have the two spontaneous urine voids of less than 200 mL will be considered as having developed POUR. The incidence of POUR will be compared statistically between those taking and not taking tamsulosin at the time of surgery.	Postop day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of Hospital Stay	Length of hospital stay will be recorded in days and compared statistically between the two groups .	1-4 days postoperative
Incidence of Discharge to a Skilled Nursing Facility	Discharge to a skilled nursing facility will be recorded (yes/no) and compared statistically between the two groups.	1-4 days postoperative
Incidence of Surgical Site Infection	Surgical site infection will be recorded (yes/no) and compared statistically between the two groups.	Up to two weeks postoperative
Acute Postoperative Pain Medication Dosages	The dosages of postoperative pain medications will be compared statistically between the two groups.	Postoperative day 1 to day of discharge (1-4 days on average)
Incidence of Postoperative Complications	Postoperative complications will be recorded and the incidence will be compared statistically between the two groups.	Up to 31 days postoperative

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Andrew Urquhart, MD, University of Michigan, Dept of Orthopaedic Surgery; Study Director: Manuel Schubert, MD, University of Michigan, Dept of Orthopaedic Surgery

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2015
• Primary Completion (Actual): June 5, 2018
• Study Completion (Actual): December 19, 2018

Study Registration Dates

• First Submitted: July 27, 2015
• First Submitted That Met QC Criteria: August 5, 2015
• First Posted (Estimate): August 10, 2015

Study Record Updates

• Last Update Posted (Actual): April 12, 2019
• Last Update Submitted That Met QC Criteria: March 21, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urination Disorders; Urinary Retention; Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Urological Agents; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Tamsulosin
• Other Study ID Numbers: HUM00087825

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No