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

Suzanne L Groah; Rochelle E Tractenberg

doi:10.46292/sci22-00005

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

Top Spinal Cord Inj Rehabil. 2022 Fall;28(4):12-21. doi: 10.46292/sci22-00005. Epub 2022 Nov 15.

Authors

Suzanne L Groah^{1

2}, Rochelle E Tractenberg³

Affiliations

¹ MedStar National Rehabilitation Hospital, Washington, DC.
² MedStar Georgetown University Hospital, Washington, DC.
³ Collaborative for Research on Outcomes and Metrics, and Departments of Neurology, Biostatistics, Bioinformatics & Biomathematics, and Rehabilitation Medicine, Georgetown University, Washington, DC.

Abstract

Background: Complicated urinary tract infection (cUTI) is pervasive and costly among people with spinal cord injury (SCI) and neurogenic lower urinary tract dysfunction (NLUTD).

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.

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.

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.

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.

Keywords: Lactobacillus rhamnosus; comparative effectiveness research; intravesical instillation; lower urinary tract symptoms; neurogenic bladder; urinary tract infections.

Publication types

Clinical Trial Protocol

MeSH terms

Humans
Lacticaseibacillus rhamnosus*
Randomized Controlled Trials as Topic
Saline Solution
Spinal Cord Injuries* / complications
Urinary Bladder
Urinary Bladder, Neurogenic* / therapy

Substances

Saline Solution

Grants and funding

Financial Support The contents of this article were developed under a grant from the National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR grant no. 90SIMS009-01). NIDILRR is a Center within the Administration for Community Living (ACL), Department of Health and Human Services (HHS). The contents of this article do not necessarily represent the policy of NIDILRR, ACL, or HHS, and you should not assume endorsement by the Federal Government.