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

Top Spinal Cord Inj Rehabil, 2022 · DOI: 10.46292/sci22-00005 · Published: December 1, 2022

Spinal Cord Injury Urology Rehabilitation

Simple Explanation

This study aims to evaluate the effectiveness of intravesical Lactobacillus rhamnosus GG (LGG) versus saline bladder wash (BW) for managing urinary symptoms in individuals with spinal cord injury (SCI) and neurogenic lower urinary tract dysfunction (NLUTD). The research will involve a comparative effectiveness trial where participants self-administer either LGG or saline bladder wash. The study consists of two phases: a treatment phase where participants use the assigned intervention (LGG or saline) when trigger symptoms occur (cloudy or foul-smelling urine), and a prophylaxis phase where participants use the intervention every three days after the initial occurrence of trigger symptoms. The trial incorporates a 'predictive enrichment' step, screening participants to ensure they are likely to experience urinary symptoms during the study. This involves monitoring symptoms for up to six months, and only those who experience trigger symptoms twice are randomized into the treatment phase.

Study Duration

6 months treatment and 6 months prophylaxis

Participants

120 participants with SCI+NLUTD at least 6 months post SCI

Evidence Level

Level 1: Randomized, controlled, comparative effectiveness trial

Key Findings

1
The study will compare the effects of LGG and saline bladder wash on urinary symptoms, episodes of presumed UTIs, antibiotic use, days of lost activity, healthcare engagement, number of instillations, satisfaction, and safety.
2
The research emphasizes a comprehensive approach to cUTI, targeting the underlying mechanisms and phenotypes rather than assuming a single, simple UTI entity.
3
The protocol's design elements, including reliable outcome measures, appropriate analytic methods for self-report, and inclusion of both intervention and prophylactic phases, may be adopted for future research.

Research Summary

The study protocol describes a comparative effectiveness trial evaluating intravesical Lactobacillus rhamnosus GG (LGG) versus saline bladder wash (BW) for managing urinary symptoms in individuals with spinal cord injury (SCI) and neurogenic lower urinary tract dysfunction (NLUTD). The trial incorporates a two-phase design (treatment and prophylaxis) and a predictive enrichment protocol to optimize participant selection and study power. The primary outcomes are symptom burden related to bladder and urine quality, measured using the Urinary Symptom Questionnaire for Neurogenic Bladder (USQNB). The study aims to provide insights into the effectiveness of LGG in comparison to saline bladder wash for self-management of urinary symptoms and prevention of UTIs in this population.

Practical Implications

Clinical Practice

The findings may inform clinical practice by providing evidence for an antibiotic-sparing approach to managing cUTI in individuals with SCI and NLUTD.

Research Methodology

The study's design, including predictive enrichment and the use of urinary symptom burden as a primary outcome, can serve as a model for future clinical trials in SCI and related populations.

Patient Self-Management

The self-management protocols used in the trial may empower patients to actively manage their urinary symptoms and reduce reliance on antibiotics.

Study Limitations

1
The study is limited to individuals with SCI and NLUTD who use intermittent catheterization.
2
The generalizability of the findings may be limited by the specific inclusion and exclusion criteria.
3
The study relies on self-reported data, which may be subject to recall bias.

Your Feedback

Was this summary helpful?

Back to Spinal Cord Injury