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Completed
NCT04373512
Intravesical Lactobacillus to Reduce Urinary Symptoms After Spinal Cord Injury
Conditions: Spinal Cord Injuries, Neurogenic Bladder
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 182
Sponsor: Medstar Health Research Institute
Location: MedStar National Rehabilitation Hospital Washington D.C. District of Columbia
Summary
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.
Eligibility Criteria
Inclusion Criteria:
* SCI at least 1-year duration;
* Neurogenic bladder;
* Utilizing intermittent catheterization for bladder management;
* Women must be premenopausal and not currently menstruating;
* Community dwelling
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.
Source: ClinicalTrials.gov (NCT04373512). StuddyBuddy aggregates publicly available trial information.
