Intravesical Lactobacillus rhamnosusGG Versus Saline Bladder Wash: A Randomized, Controlled, Comparative Effectiveness Clinical Trial

What this Trial Is About

This research aims to compare the effectiveness of a new self-management approach using an antibiotic-sparing treatment to prevent complicated urinary tract infections (UTIs) in people with spinal cord injury (SCI) and neurogenic bladder (NB). UTIs are common and serious complications for this group, causing frequent infections, emergency visits, and hospitalizations. The study addresses challenges in diagnosing UTIs in this population due to limitations of standard tests and persistent inflammation that affects urine markers. The trial compares two approaches: one group uses Lactobacillus Rhamnosus GG (LGG) mixed with saline bladder wash, while the other group uses saline bladder wash alone. Participants will self-administer these treatments through intermittent catheterization after the last catheterization before bedtime when they notice specific symptoms like cloudier or foul-smelling urine. There are treatment and prophylaxis phases lasting six months each, with different dosing schedules depending on the phase. During the study, participants will complete symptom questionnaires in real time when symptoms occur and at scheduled intervals after instillations. Researchers will monitor symptom burden, days lost from work or rehabilitation, healthcare interactions, and antibiotic use. Patient satisfaction with treatments and dropout reasons will also be assessed. The study includes baseline data collection and regular follow-up over up to 18 months to evaluate these outcomes comprehensively.

Intravesical LGG VS Saline Bladder Wash RCT