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.
Status | Recruiting |
Enrollment | 182 |
Est. completion date | September 2025 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | MedStar National Rehabilitation Hospital | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Medstar Health Research Institute | Children's National Research Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter | Will measure change in urinary symptoms for those that use an indwelling catheter. Higher score may mean worse outcomes. (local urine collection participants only) | (SA 1) day of urine collection | |
Primary | Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter | Will measure change in urinary symptoms for those that use an indwelling catheter. Higher score may mean worse outcomes. (local urine collection participants only) | (SA 1) day 1 post urine collection | |
Primary | Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter | Will measure change in urinary symptoms for those that use an indwelling catheter. Higher score may mean worse outcomes. (local urine collection participants only) | (SA 1) day 2 post urine collection | |
Primary | Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter | Will measure change in urinary symptoms for those that use an indwelling catheter. Higher score may mean worse outcomes. (local urine collection participants only) | (SA 1) day 3 post urine collection | |
Primary | Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter | Will measure change in urinary symptoms for those that use an indwelling catheter. Higher score may mean worse outcomes | (SA 2) Weekly up to 29 months | |
Primary | Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter | Will measure change in urinary symptoms for those that use an indwelling catheter. Higher score may mean worse outcomes. (local urine collection participants only) | (SA 2) day 1 of intervention (low or high dose) | |
Primary | Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter | Will measure change in urinary symptoms for those that use an indwelling catheter. Higher score may mean worse outcomes | (SA 2) day 2 of intervention (low or high dose) | |
Primary | Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter | Will measure change in urinary symptoms for those that use an indwelling catheter. Higher score may mean worse outcomes | (SA 2) day 3 of intervention (low or high dose) | |
Primary | Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter | Will measure change in urinary symptoms for those that use an indwelling catheter. Higher score may mean worse outcomes | (SA 2) day 4 of intervention (low or high dose) | |
Primary | Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter | Will measure change in urinary symptoms for those that use an indwelling catheter. Higher score may mean worse outcomes | (SA 2) day 5 of intervention (high dose only) | |
Primary | Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter | Will measure change in urinary symptoms for those that use an indwelling catheter. Higher score may mean worse outcomes. (local urine collection participants only) | (SA 2) 24-48 hours after intervention completion | |
Primary | Change in Urine white blood cell count | urinalysis. (local urine collection participants only) | (SA 1) day 1 post urine collection | |
Primary | Change in Urine white blood cell count | urinalysis. (local urine collection participants only) | (SA 1) day 14 post urine collection | |
Primary | Change in Urine white blood cell count | urinalysis. (local urine collection participants only) | (SA 2) day 1 of intervention | |
Primary | Change in Urine white blood cell count | urinalysis. (local urine collection participants only) | (SA 2) 24-48 hours after intervention completion | |
Primary | Change in Urine Nitrite | urinalysis. (local urine collection participants only) | (SA 1) day 1 post urine collection | |
Primary | Change in Urine Nitrite | urinalysis. (local urine collection participants only) | (SA 1) day 14 post urine collection | |
Primary | Change in Urine Nitrite | urinalysis. (local urine collection participants only) | (SA 2) day 1 of intervention | |
Primary | Change in Urine Nitrite | urinalysis. (local urine collection participants only) | (SA 2) 24-48 hours after intervention completion | |
Primary | Change in Urine NGAL | Urine NGAL. (local urine collection participants only) | (SA 1) day 1 post urine collection | |
Primary | Change in Urine NGAL | Urine NGAL. (local urine collection participants only) | (SA 1) day 14 post urine collection | |
Primary | Change in Urine NGAL | Urine NGAL. (local urine collection participants only) | (SA 2) day 1 of intervention | |
Primary | Change in Urine NGAL | Urine NGAL. (local urine collection participants only) | (SA 2) 24-48 hours after intervention completion | |
Primary | Change in Cultivable Bacteria | urine culture. (local urine collection participants only) | (SA 1) day 1 post urine collection | |
Primary | Change in Cultivable Bacteria | urine culture. (local urine collection participants only) | (SA 1) day 14 post urine collection | |
Primary | Change in Cultivable Bacteria | urine culture. (local urine collection participants only) | (SA 2) day 1 of intervention | |
Primary | Change in Cultivable Bacteria | urine culture. (local urine collection participants only) | (SA 2) 24-48 hours after intervention completion | |
Primary | Change in Urine microbiome composition and function | Next generation sequencing for microbiome composition. (local urine collection participants only) | (SA 1) day 1 post urine collection | |
Primary | Change in Urine microbiome composition and function | Next generation sequencing for microbiome composition. (local urine collection participants only) | (SA 1) day 14 post urine collection | |
Primary | Change in Urine microbiome composition and function | Next generation sequencing for microbiome composition. (local urine collection participants only) | (SA 2) day 1 of intervention | |
Primary | Change in Urine microbiome composition and function | Next generation sequencing for microbiome composition. (local urine collection participants only) | (SA 2) 24-48 hours after intervention completion | |
Primary | NINDS Medical History CDE: | A brief medical history using body system categories | Baseline | |
Primary | Medical History Form | Medical history of participant | Baseline | |
Primary | International SCI Lower Urinary Tract Function Basic Data Set | A tool to describe urinary tract impairment, awareness of need to empty the bladder, main bladder emptying method, medications used for bladder management, surgeries, and change in urinary symptoms in the past year. | Baseline | |
Primary | NINDS Prior and Concomitant Medications CDE | Contains whether or not the participant is taking a medication during the study protocol, name of medication, reason for medication, medication dose, frequency, start and end dates, and free text | Baseline |
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