Pilot Study of Avoidance of Bladder Catheters in Stroke Patients to Avoid Urinary Tract Infections

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01275261
Recruitment Status : Terminated (Investigator no longer at institution-no data analyzed)
First Posted : January 12, 2011
Last Update Posted : November 14, 2012
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
The purpose of this study is to determine whether bladder catheterization can be safely avoided in patients admitted to the hospital with stroke using a nursing protocol, and whether this decreases the incidence of urinary tract infections. The investigators hypothesize that the protocol will be tolerated by nurses and patients, and that patients without bladder catheters will have fewer urinary tract infections and better outcomes.

Condition or disease Intervention/treatment Phase
Stroke Catheter Associated Urinary Tract Infection Behavioral: Nursing protocol to avoid Foley catheter placement Phase 2

Detailed Description:

Medical complications, both minor and serious, play a large role in post-stroke management and outcome. Infection, especially pneumonia and urinary tract infections (UTI), is one of the most common medical complications of stroke. In addition, immunosuppression secondary to stroke may increase the risk of infection after stroke, and fever secondary to infection may result in poor outcomes. UTIs occur in 3 to 16% of patients within the first week to month after a cerebrovascular event. Compared with patients who do not develop post-stroke UTIs, those who do have a UTI have poorer outcomes; such patients have an approximately 3-fold increased odds of a higher mRS, and a 4.5-fold higher odds for the combined endpoint of death or disability.

Between 15% and 25% of all hospitalized patients receive short-term indwelling urinary catheters, often unnecessarily. In the general medical population, the risk of UTI ranges from 3%-10% per day of catheterization, and approaches 100% after 30 continuous days. Catheter-associated UTI (CAUTI) is the second most commonly reported healthcare-associated infection in acute care hospitals, accounting for approximately one-third of all infections reported to the National Healthcare Safety Network in 2006-2007, and is the leading cause of secondary nosocomial bloodstream infections. CAUTIs have been estimated to cost $589 to $758 per infection, and between 17 and 69% may be preventable.

The recently released draft guidelines from the Centers for Disease Control and Prevention (CDC) for prevention of CAUTI suggest appropriate indications for indwelling urethral catheter use, including acute urinary retention or obstruction, need for accurate measurements of urinary output in critically ill patients, and prolonged immobilization, but an estimated 20 to 50% of hospitalized patients have urinary catheters placed without clear indications.

We will conduct a pilot RCT to determine the tolerability and efficacy of a protocol to avoid catheter placement in patients admitted to the UCSF neurovascular service with ischemic stroke or intracerebral hemorrhage. There are two study arms: a usual care control group will have catheter placement on admission, and the intervention group will not have a catheter placed on admission. The intervention arm will be treated using a protocol, developed with a multidisciplinary team, and instituted by nurses to avoid the need for catheter placement. The sample will be followed during hospital admission, with the main outcome measures being the tolerability of the protocol by the nursing staff, patient comfort and the incidence of UTI during hospitalization. The subjects will be followed during their hospitalization and a follow-up telephone call will be made to them at 90-days post-stroke.

We hypothesize that limiting the use of Foley catheters to the medical indications noted in the CDC guidelines, which is not current standard practice, will decrease the number of catheters placed, and thereby reduce the number of UTIs in stroke patients. The ultimate goal of this study is to improve clinical outcomes, decrease hospital length of stay, cost of care, and time to rehabilitation among patients who suffer a stroke.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Pilot Randomized Trial of a Nursing Protocol to Avoid Bladder Catheterization in Patients With Stroke
Study Start Date : January 2011
Primary Completion Date : September 2011
Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
No Intervention: Foley catheter
Usual care - patients will have a Foley catheter placed on admission.
Experimental: Nursing protocol to avoid Foley Catheter
No catheter will be placed on admission, and a nursing order protocol will be followed to avoid catheterization and avoid complications.
Behavioral: Nursing protocol to avoid Foley catheter placement
A specific nursing order protocol will be followed addressing urinary care to try to avoid the use of Foley catheters.

Primary Outcome Measures :
  1. Patient comfort. [ Time Frame: On discharge (average 4 days after stroke) ]
    This will be assessed using a questionnaire at discharge addressing comfort of urinary care.

  2. Amount of time spent by nurses on patient urinary care [ Time Frame: Will be measured at the end of each nursing shift during the patients hospitalization. ]
    This will be assessed using a questionnaire filled out at the end of each nursing shift addressing time management and comfort with the urinary care of the patient.

Secondary Outcome Measures :
  1. Incidence of Urinary Tract infection [ Time Frame: during acute hospitalization, average 4 days after stroke ]
    Determined using UTI symptoms and urinalysis and urine culture findings.

  2. Stroke Functional Outcome [ Time Frame: 90 days ]
    Using the modified Rankin Scale by telephone interview.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adults aged ≥18
  • Admission to the neurovascular service at UCSF (from the ED or from an outside hospital)
  • Diagnosis of acute stroke or intracerebral hemorrhage

Exclusion Criteria:

  • Glasgow Coma Scale (GCS) <9
  • Need for intubation or sedation
  • An active medical problem requiring the use of a bladder catheter (e.g., congestive heart failure exacerbation, acute bladder outlet obstruction)
  • Subarachnoid hemorrhage
  • Patients who are asymptomatic or have minimal symptoms from stroke
  • Bladder catheter already in place for >12 hours
  • Contraindication for bladder catheterization
  • Evidence of UTI on admission

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01275261

United States, California
University of California San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Principal Investigator: Sharon N Poisson, MD University of California, San Francisco

Responsible Party: University of California, San Francisco Identifier: NCT01275261     History of Changes
Other Study ID Numbers: 10-00820
First Posted: January 12, 2011    Key Record Dates
Last Update Posted: November 14, 2012
Last Verified: November 2012

Keywords provided by University of California, San Francisco:
Urinary Tract Infection

Additional relevant MeSH terms:
Communicable Diseases
Urinary Tract Infections
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Urologic Diseases