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Effects of Intravesical Lactobacillus Rhamnosus GG on Urinary Symptom Burden in People with Neurogenic Lower Urinary Tract Dysfunction.

  • 2020-11-10
  • PM & R : the journal of injury, function, and rehabilitation 13(7)
    • Rochelle E Tractenberg
    • Suzanne L Groah
    • Jamie K Frost
    • Amanda K Rounds
    • Elizabeth Davis
    • Inger H Ljungberg
    • Manon M Schladen

Study Design

Type
Clinical Trial
Population
Ninety-six adults and seven children with SCI/D
Methods
Three-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. In response to trigger symptoms, participants self-administered using a clean urinary catheter an LGG+ Normal Saline instillate once or twice in a 30-hour period.
Blinding
Open-label
Duration
6 months each in baseline, intervention, and washout
Funding
Unclear

Objective

To 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).

Design

A three-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.

Setting

Nationwide (United States).

Participants

Ninety-six adults and seven children with SCI/D.

Interventions

In response to one or both of the SMP-Pro trigger urinary symptoms, "cloudier" or "foul smelling" urine, participants 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 previous 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.

Results

During the intervention phase, participants met SMP-Pro instillation criteria 3.83 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 < .05).

Conclusions

Self-instilled LGG seemed 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 intravesical LGG, and the SMP-Pro for urinary symptoms.

Research Insights

  • Lactobacillus rhamnosus GG→Reduced Urinary Symptom Burden

    For those who instilled at least once, burdens of type A and B2 symptoms were significantly improved at washout (both adjusted P < .05).

    Effect
    Beneficial
    Effect size
    Small
    Dose
    instilled once or twice in a 30-hour period (5.6 doses on average)
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