TY  - BOOK
AU  - Groah, Suzanne
TI  - Intravesical Lactobacillus rhamnosus GG versus Saline Bladder Wash: Protocol for a Randomized, Controlled, Comparative Effectiveness Clinical Trial
SN  - 1082-0744
PY  - 2022///
KW  - IN PROCESS -- NOT YET INDEXED
KW  - MedStar National Rehabilitation Network
KW  - Journal Article
N1  - Available in print through MWHC library: 1999 - Winter 2007
N2  - Background: Complicated urinary tract infection (cUTI) is pervasive and costly among people with spinal cord injury (SCI) and neurogenic lower urinary tract dysfunction (NLUTD); Conclusion: cUTI is a variable clinical entity. Unlike clinical trials that assume a single, simple entity (UTI) in inclusion or outcome criteria, this protocol targets the mechanisms underlying cUTI causes and phenotypes. Featuring reliable and valid outcome measures with analytic methods specifically appropriate for quantifying self-report, patient self-management, inclusion of both intervention and prophylactic phases, and predictive enrichment, these design elements may be adopted for future research. Copyright © 2022 American Spinal Injury Association; Methods: Comparative effectiveness trial of self-administered LGG versus saline bladder wash among 120 participants with SCI+NLUTD at least 6 months post SCI. The study has both treatment and prophylaxis phases. After predictive enrichment at screening, randomized participants will enter the treatment phase (6 months) in which they instill either LGG or normal saline after trigger symptoms occur (more cloudy or more foul-smelling urine). In the prophylaxis phase (6 months), participants will instill their respective intervention every 3 days after the first occurrence of trigger symptoms; Objectives: To describe the protocol for a comparative effectiveness randomized controlled trial of intravesical Lactobacillus rhamnosus GG (LGG) versus saline bladder wash (BW) for self-management of urinary symptoms; Results: Study results will provide a comparison of effects on Urinary Symptom Questionnaire for Neurogenic Bladder (USQNB) bladder and urine symptoms and episodes of "presumed UTIs"; number of days antibiotics were used (both self-reported); days of work, school, rehabilitation, or other activity lost due to urinary symptoms; engagement with the health care system; number of instillations; satisfaction; and safety
UR  - https://dx.doi.org/10.46292/sci22-00005
ER  -