Neurogenic Bladder Clinical Trial
Official title:
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). ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT02978638 -
Electrical Stimulation for Continence After Spinal Cord Injury
|
N/A | |
Enrolling by invitation |
NCT06429631 -
The Effect of CIC Education on QOL and Compliance With Mobile Application in Individuals With Spinal Cord Injury.
|
N/A | |
Completed |
NCT03573726 -
Use of a Diurnal Indwelling Urethral Catheter to Improve Quality of Life
|
N/A | |
Recruiting |
NCT06059066 -
Optimization of OnabotulinumtoxinA (BTX-A) Injection for the Treatment of Neurogenic Lower Urinary Tract Dysfunction
|
N/A | |
Completed |
NCT01429090 -
Bioavailability of Vagantin® Coated Tablets Relative to an Oral Methantheline Bromide Solution
|
Phase 1 | |
Recruiting |
NCT05587101 -
Neurogenic Lower Urinary Tract Symptoms in Patients With Multiple Sclerosis
|
||
Terminated |
NCT03843073 -
Connected Catheter- Safety and Effectiveness Study
|
N/A | |
Terminated |
NCT04059159 -
Connected Catheter - Safety and Effectiveness Study
|
N/A | |
Completed |
NCT05861024 -
Urinary Calculi After Bladder Augmentation in Children
|
||
Completed |
NCT05858840 -
Urinary Artificial Sphincter in Children
|
||
Completed |
NCT04074616 -
Reducing Anticholinergic Bladder Medication Use in Spinal Cord Injury With Home Neuromodulation
|
N/A | |
Completed |
NCT05683938 -
GentleCathâ„¢ Air Intermittent Catheter Smartwatch Real Life Pilot Study
|
||
Completed |
NCT04543552 -
A Comparative Analysis of Portable Bladder Scanner to Determine Age/ Volume Specific Accuracy in 0-6 Years of Children
|
||
Active, not recruiting |
NCT06247033 -
Efficacies of Different Managements in Patients With Overactive Bladder With Stroke
|
N/A | |
Withdrawn |
NCT01305681 -
Bacterial Properties With LoFric® Catheters During Clean Intermittent Catheterization
|
Phase 1/Phase 2 | |
Recruiting |
NCT04248322 -
Qualitative Assessment of the Impact of TTNS on QOL and Participation
|
||
Recruiting |
NCT05301335 -
Spinal COrd NeuromodulaTor by SpIneX and ScoNE to Treat NeurogeniC BladdEr - SCONE "CONTINENCE" Clinical Study
|
N/A | |
Recruiting |
NCT04924569 -
Continence Care Registry
|
||
Completed |
NCT01716624 -
Botox Versus Oxybutynin as First Line Treatment for the Poorly Compliant Pediatric Neurogenic Bladder
|
Phase 3 | |
Completed |
NCT01297647 -
Incidence of Urinary Tract Infection After Urodynamic Investigation
|
N/A |