Intravesical Lactobacillus rhamnosus GG is safe and well tolerated in adults and children with neurogenic lower urinary tract dysfunction: first-in-human trial

Therapeutic Advances in Urology, 2019 · DOI: 10.1177/1756287219875594 · Published: June 17, 2019

Simple Explanation

This study investigates the safety and tolerability of using Lactobacillus rhamnosus GG (LGG®), a probiotic, directly in the bladder to manage urinary symptoms in people with neurogenic lower urinary tract dysfunction (NLUTD). The study involved adults and children with NLUTD due to spinal cord injury or disease (SCI/D) who use intermittent catheterization (IC). They self-instilled LGG® when they noticed cloudy or foul-smelling urine. The results showed that this method of using LGG® was safe and well-tolerated by the participants. This suggests it could be a potential way for people with NLUTD to manage their urinary symptoms.

Study Duration

18 months

Participants

103 individuals with SCI/D

Evidence Level

Not specified

Key Findings

1
One or two doses of self-instilled intravesical LGG® in response to more cloudy or foul-smelling urine was safe and well tolerated among adults and children with SCI/D who have NLUTD and use IC.
2
AEs+SAEs occurred throughout the study at a rate that did not associate with LGG® use.
3
The data suggest that the rate of AE+SAEs was greatest prior to any instillation of LGG® for both children and adults.

Research Summary

The study assessed the safety and tolerability of self-administered intravesical LGG® in adults and children with NLUTD due to SCI/D who use intermittent catheterization. Participants self-instilled LGG® in response to cloudy or foul-smelling urine, and the study monitored adverse events and tolerability. The results indicated that the intervention was safe and well-tolerated, with no significant increase in adverse events associated with LGG® use.

Practical Implications

Potential Self-Management Strategy

Intravesical LGG® instillation may offer a self-management approach for individuals with NLUTD experiencing urinary symptoms like cloudy or foul-smelling urine.

Further Research Needed

Additional studies are necessary to evaluate the effectiveness of intravesical LGG® in reducing urinary symptom burden and preventing UTIs in this population.

Personalized Probiotic Approach

Future research should consider factors such as the specific probiotic strain, route of administration, dosing, and patient population to optimize the use of probiotics for urinary health.

Study Limitations

1
Assessment of symptoms must be done in real time with the SMP-Pro to determine more precisely whether there are difficulties in the SMP-Pro for its use as a self-management tool, further studies are needed to generate estimates of correct/incorrect implementation of the protocol itself.
2
It was unexpected that there were so many more SAEs than AEs; this exemplifies the natural history of secondary conditions occurring among people with NLUTD due to SCI/D, SB, and MS, suggesting that future studies must consider AEs and SAEs in analysis plans and study designs.
3
variability in these like-lihood ratings was very high. The conclusion that AE+SAE experience and willingness to seek out and pay for the intervention are independent is not due to sample size, but might be due to vari-ability among participants.

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