Prevention of Urinary Tract Infection (UTI) in Persons With Spinal Cord Injury (SCI)

Completed · Not applicable · Has a placebo group

Conditions studied: Urinary Tract Infections

In brief

Urinary tract infection (UTI) is the most common infection in patients with spinal cord injury (SCI) and is linked to major undesired results or complications including death. The bladder of SCI patients, especially those with indwelling catheters, is usually colonized by bacteria, some of which do and others which do not cause symptoms of UTI. Bacteria that do not cause symptoms are often called benign colonizers and are often left untreated because they may provide some protection against infection with more harmful bacteria. This idea of using benign bacteria to prevent infections with symptoms is called bacterial interference. A prototype strain, Escherichia coli 83972, was shown to begin and continue for extended periods of time non symptom causing colonization of the human bladder and to hold back symptom causing infections of the neurogenic bladder. Data from pilot studies at two medical centers indicated that bacterial interference might be a useful therapy for reducing the rate or frequency of UTI in SCI patients. Because almost all SCI patients have a UTI at some time, and also the large costs of treating this infection, studying the impact of bladder colonization with E. coli 83972 on the rate of symptom causing UTI has an amazing potential for improving the quality of life of SCI patients and decreasing the cost of health care. Like with other preventive plans such as vaccination, for instance, it is important to explore the effectiveness of this new preventive approach. The project is a prospective, randomized, double blind, multi-center study that deals with specific pieces of bacterial interference in SCI patients. HYPOTHESES: Placing non symptom causing bacteria (E. coli 83972) into SCI patients' bladders reduces the rate of symptom causing UTI. A. SPECIFIC AIM: Determine how bladder colonization with E. coli 83972 or similar bacteria affects the rate of symptom causing urinary tract infections in a large group of SCI and Spina Bifida patients by conducting a prospective, randomized, placebo-controlled, multi-center clinical trial.

Key facts

Study ID

NCT00309114

Run by

Baylor College of Medicine

People needed

65

Starts

2004-02-01

Expected to finish

2009-11-01

Last updated by the study team

2017-02-23

Who can join

Age: 15 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 15 years or older
• Living in institutional or non-institutional settings
• 6 months post spinal cord injury (SCI) prior to entry or have Spina Bifida
• Loss of bladder function
• Loss of normal bladder sensation
• Selected in-patients involved in the Rehab I program
• Catheter dependent, having either an indwelling urinary catheter or using an external catheter, intermittent catheterization, or vesical urinary diversion (original bladder, whole or in part, serves as the collection receptacle for urine) for bladder management.
• Two or more urinary tract infections (UTI) within the 12 months prior to the study.
• Capable of understanding the purpose of the study and providing informed consent to participate
• Pursue appropriate follow-up over the course of the study.

You may not qualify if…

• Any bladder stone(s)
• Kidney stone(s) greater than 1 cm in size
• Any obstructing kidney stone regardless of size
• Nephrostomy tube(s)
• Supravesical diversion (original bladder is no longer part of the collection receptacle for urine)
• Congenital genitourinary anomaly that predisposes to UTI
• Conditions anticipated to require recurrent antibiotic therapy for extraurogenital infection (e.g., recurrent pneumonia, decubitus ulcer)
• Current immunosuppression
• Vascular prosthesis
• Congenital or acquired cardiac disease susceptible to vegetative infections
• Bladder capacity of less than 50 cc
• Individuals with known significant cognitive impairment resulting from trauma, disease, or congenital conditions
• Women of childbearing age who engage in unprotected intercourse
• Women who are currently pregnant will be included in the study
• Women who become pregnant during the study will be discontinued from participation. Pregnant women who experience UTI or prolonged asymptomatic bacteriuria are at risk of bearing infants with low birth weight.
• Children
• Prisoners
• Men and women with significant known mental illness or emotional disorders related to organic or inorganic causes.

Where it is running

• Shepherd Center — Atlanta, Georgia, United States
• Rehab Institute Chicago — Chicago, Illinois, United States
• UT Southwestern — Dallas, Texas, United States
• Michael E Debakey VA Medical Center — Houston, Texas, United States
• The Institute for Rehabilitation and Research (TIRR) — Houston, Texas, United States

Full record on ClinicalTrials.gov

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