Intravesical Lactobacillus rhamnosus GG versus Saline Bladder Wash: Protocol for a Randomized, Controlled, Comparative Effectiveness Clinical Trial.

MedStar author(s):
Citation: Topics in Spinal Cord Injury Rehabilitation. 28(4):12-21, 2022 Fall.PMID: 36457355Institution: MedStar National Rehabilitation NetworkForm of publication: Journal ArticleMedline article type(s): Journal ArticleSubject headings: IN PROCESS -- NOT YET INDEXEDYear: 2022Local holdings: Available in print through MWHC library: 1999 - Winter 2007ISSN:
  • 1082-0744
Name of journal: Topics in spinal cord injury rehabilitationAbstract: 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.All authors: Groah SL, Tractenberg REFiscal year: FY2023Digital Object Identifier: Date added to catalog: 2022-12-13
Holdings
Item type Current library Collection Call number Status Date due Barcode
Journal Article MedStar Authors Catalog Article 36457355 Available 36457355

Available in print through MWHC library: 1999 - Winter 2007

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.

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