Intravesical Lactobacillus RhamnosusGG to Reduce Urinary Symptoms in Adults With Neurogenic Bladder Using Indwelling Catheters Phase 2 Prevention Study

What this Trial Is About

Researchers are studying urinary symptoms and urine health in people with neurogenic bladder who use indwelling catheters. They aim to understand meaningful changes in urinary symptoms, urine inflammation, bacteria, and the urines microbial environment. The study also seeks to find the best dose of Lactobacillus Rhamnosus GG LGG4 delivered directly into the bladder to reduce urinary symptoms for future trials. Participants will receive LGG4 instilled through their indwelling catheter in one of two dosage groups. The low dose involves mixing one LGG capsule in saline and instilling two doses over two days. The high dose includes four LGG capsules instilled twice daily for two days, totaling four doses. After instillation, participants plug their catheter for one hour. The study lasts up to 29 months, ending after one intervention and follow-up. Participants complete a weekly urinary symptom questionnaire during the study. During participation, researchers will collect urine samples and assess changes in urinary symptoms, inflammation markers, bacteria levels, and the urine microbiome over multiple days before and after interventions. Questionnaires about urinary symptoms are completed regularly, and medical history and bladder function data are collected at baseline. The study monitors changes in white blood cells, nitrites, NGAL, and cultivable bacteria in urine. Participants will be followed for up to 29 months or until study completion after intervention and assessments.

Intravesical Lactobacillus for Urinary Symptoms Among People With NLUTD Who Use Indwelling Catheters