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

Primary Purpose

Postoperative Urinary Retention

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Tamsulosin
Placebo
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Urinary Retention

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

  • University of Michigan Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

tamsulosin

placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Length of Hospital Stay
Length of hospital stay will be recorded in days and compared statistically between the two groups .
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.
Incidence of Surgical Site Infection
Surgical site infection will be recorded (yes/no) and compared statistically between the two groups.
Acute Postoperative Pain Medication Dosages
The dosages of postoperative pain medications will be compared statistically between the two groups.
Incidence of Postoperative Complications
Postoperative complications will be recorded and the incidence will be compared statistically between the two groups.

Full Information

First Posted
July 27, 2015
Last Updated
March 21, 2019
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT02518971
Brief Title
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

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Terminated
Why Stopped
interim analysis revealed no significant difference between study groups & increased sample size required to gain significance.
Study Start Date
August 2015 (Actual)
Primary Completion Date
June 5, 2018 (Actual)
Study Completion Date
December 19, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Urinary Retention

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
176 (Actual)

8. Arms, Groups, and Interventions

Arm Title
tamsulosin
Arm Type
Experimental
Arm Description
0.4 mg daily for five days pre-op through post-op day one (seven total)
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
One capsule daily for five days pre-op through post-op day one (seven total)
Intervention Type
Drug
Intervention Name(s)
Tamsulosin
Other Intervention Name(s)
Flomax
Intervention Description
0.4 mg daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
one capsule daily
Primary Outcome Measure Information:
Title
Number of Patients to Develop Postoperative Urinary Retention (POUR)
Description
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.
Time Frame
Postop day 1
Secondary Outcome Measure Information:
Title
Length of Hospital Stay
Description
Length of hospital stay will be recorded in days and compared statistically between the two groups .
Time Frame
1-4 days postoperative
Title
Incidence of Discharge to a Skilled Nursing Facility
Description
Discharge to a skilled nursing facility will be recorded (yes/no) and compared statistically between the two groups.
Time Frame
1-4 days postoperative
Title
Incidence of Surgical Site Infection
Description
Surgical site infection will be recorded (yes/no) and compared statistically between the two groups.
Time Frame
Up to two weeks postoperative
Title
Acute Postoperative Pain Medication Dosages
Description
The dosages of postoperative pain medications will be compared statistically between the two groups.
Time Frame
Postoperative day 1 to day of discharge (1-4 days on average)
Title
Incidence of Postoperative Complications
Description
Postoperative complications will be recorded and the incidence will be compared statistically between the two groups.
Time Frame
Up to 31 days postoperative

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Urquhart, MD
Organizational Affiliation
University of Michigan, Dept of Orthopaedic Surgery
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Manuel Schubert, MD
Organizational Affiliation
University of Michigan, Dept of Orthopaedic Surgery
Official's Role
Study Director
Facility Information:
Facility Name
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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