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Status:

COMPLETED

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

Lead Sponsor:

Baylor College of Medicine

Conditions:

Urinary Tract Infections

Eligibility:

All Genders

15-64 years

Phase:

NA

Brief Summary

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 patie...

Detailed Description

This clinical trial will be take place in a total of 7 medical centers that care for Spinal cord injury (SCI) and Spina Bifida patients. A total of 160 patients will be allowed to take part in the stu...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

  • 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.

Key Trial Info

Start Date :

February 1 2004

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

November 1 2009

Estimated Enrollment :

65 Patients enrolled

Trial Details

Trial ID

NCT00309114

Start Date

February 1 2004

End Date

November 1 2009

Last Update

February 23 2017

Active Locations (5)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 2 (5 locations)

1

Shepherd Center

Atlanta, Georgia, United States, 30309

2

Rehab Institute Chicago

Chicago, Illinois, United States, 60611

3

UT Southwestern

Dallas, Texas, United States, 75390

4

Michael E Debakey VA Medical Center

Houston, Texas, United States, 77030