Intravesical Lactobacillus for Urinary Symptoms Among People With NLUTD Who Use Indwelling Catheters
Intravesical Lactobacillus for Urinary Symptoms Among People With NLUTD Who Use Indwelling Catheters
The objectives of the proposed research among this population are: 1) to define clinically
 meaningful change (i.e. differentiating states of health and illness) with respect to urinary
 symptoms, urine inflammation, cultivable bacteria, and the urine ecosystem; and 2) to
 determine the optimal intravesical Lactobacillus RhamnosusGG (LGG®) dose to be used to reduce
 urinary symptoms in a future clinical trial.
Urinary tract infection (UTI) is the most common outpatient infection world-wide, and for
 people with spinal cord injury (SCI) and neurogenic bladder (NB), it is the most common
 infection, secondary condition, cause for emergency room visits, and infectious cause of
 hospitalization. Despite its prevalence, attempts to ameliorate UTI among people with SCI are
 stymied by long-standing diagnostic challenges which arise from evidence gaps around "gold
 standard" diagnostic tests (urinalysis and urine culture) that have lower sensitivity and
 specificity for UTI in this population. A high prevalence of chronic inflammation leading to
 persistence of white blood cells (WBC) in the urine confounds the utility of WBC count,
 pyuria, and leukocyte esterase as biomarkers for UTI; nitrites in urine indicate the presence
 of only specific (but not all) organisms, many of which are present to a greater extent in
 the urine of people with SCI; and people with SCI have a high prevalence of asymptomatic
 bacteriuria. These physiologic changes render the gold standard diagnostic tests less useful
 for identifying UTI in persons with SCI.

 SA1. Estimate healthy, asymptomatic state variability of urine NGAL (uNGAL), white blood
 cells (uWBC), nitrite, cultivable bacteria, and the urinary microbiome.

 SA2. Estimate the effect of intravesical LGG dose on urinary symptoms (primary outcome),
 uNGAL, uWBC, nitrites, cultivable bacteria, and the urine microbiome (secondary outcomes).
Inclusion Criteria:

 -  Neurogenic bladder for at least 6 months;

 -  Utilizing indwelling catheterization for bladder management;

 -  Women must be premenopausal and not currently menstruating;

 -  Community dwelling

 -  physical disability

 Exclusion Criteria:

 -  Use of prophylactic antibiotics;

 -  Instillation of intravesical antimicrobials to prevent UTI;

 -  Psychologic or psychiatric conditions influencing the ability to follow instructions;

 -  Use of oral or IV antibiotics within the past 2 weeks;

 -  Sexual activity within the previous 72 hours;

 -  Participation in another study with which results could be confounded.