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

NCT02518971 | Terminated Phase 3 Results FDA Drug

• 1 other identifier: HUM00087825
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Urinary Retention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Length of Hospital Stay

  1-4 days postoperative

• Incidence of Discharge to a Skilled Nursing Facility

  1-4 days postoperative

• Incidence of Surgical Site Infection

  Up to two weeks postoperative

• Acute Postoperative Pain Medication Dosages

  Postoperative day 1 to day of discharge (1-4 days on average)

• Incidence of Postoperative Complications

  Up to 31 days postoperative

Study Arms (2)

tamsulosin

EXPERIMENTAL

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

Drug: Tamsulosin

placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Tamsulosin DRUG

0.4 mg daily

Also known as: Flomax

tamsulosin

Placebo DRUG

one capsule daily

placebo

Eligibility Criteria

• Age: 35 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Interventions

Tamsulosin

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Results Point of Contact

• Title: Andrew Urquhart
• Organization: Michigan Medicine

andrewu@med.umich.edu

734-936-6636

Study Officials

• Andrew Urquhart, MD

  University of Michigan, Dept of Orthopaedic Surgery

  PRINCIPAL INVESTIGATOR

• Manuel Schubert, MD

  University of Michigan, Dept of Orthopaedic Surgery

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Orthopaedic Surgery

Study Record Dates

• First Submitted: July 27, 2015
• First Posted: August 10, 2015
• Study Start: August 1, 2015
• Primary Completion: June 5, 2018
• Study Completion: December 19, 2018
• Last Updated: April 12, 2019
• Results First Posted: April 12, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)