Effects of Intravesical Lactobacillus Rhamnosus GGon Urinary Symptom Burden in People with Neurogenic Lower Urinary Tract Dysfunction.
- 2021
CONCLUSIONS: Self-instilled LGGseemed to improve "clinically actionable" (A) and "urine quality" (B2) symptom burden. No changes were observed for those who did not instill. This first-in-human clinical trial supports ongoing research of intravesicalLGG, and the SMP-Pro for urinary symptoms. This article is protected by copyright. All rights reserved. Copyright This article is protected by copyright. All rights reserved. DESIGN: A 3-phase study (6 months each in baseline; intervention; and washout). Participants self-managed following the Self-Management Protocol using Probiotics (SMP-Pro), completing the online Urinary Symptom Questionnaire for Neurogenic Bladder-IC version (USQNB-IC) weekly. INTERVENTIONS: In response to one or both of the SMP-Pro trigger urinary symptoms, "cloudier" or "foul smelling" urine, subjects self-administered using a clean urinary catheter an LGG+Normal Saline instillate once or twice in a 30-hour period. MAIN OUTCOME MEASURES: Change in USQNB-IC burden was adjusted individually according to the prior phase for four symptom types. Adjusted changes in burden between the intervention and washout phases were analyzed using one-sample t-tests. Holm correction was applied for the four types of symptoms: A, clinically actionable; B1, bladder function; B2, urine quality; and C, other. OBJECTIVE: Test the effectiveness of intravesical Lactobacillus rhamnosus GG (LGG) to reduce the burden of urinary symptoms for individuals with spinal cord injury and disease (SCI/D) with neurogenic lower urinary tract dysfunction (NLUTD) who manage their bladders with intermittent catheterization (IC). PARTICIPANTS: 96 adults and 7 children with SCI/D. RESULTS: During the intervention phase, participants met SMP-Pro instillation criteria3.83 times on average (range 1 - 20). An average of 5.6 doses of LGG were instilled.For those who instilled at least once, burdens of type A and B2 symptoms were significantly improved at washout (both adjusted p<0.05). SETTING: Nationwide (US).