Self-Management of Urinary Symptoms Using a Probiotic in People with Spinal Cord Injuries, Spina Bifida, and Multiple Sclerosis

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What was the research about?

Spinal cord injuries, spina bifida, and multiple sclerosis are health problems that affect the spinal cord and may cause problems with urination. To manage these problems, many patients use an intermittent catheter, a tube placed and removed several times a day to drain urine. But using a catheter increases the risk of infection.

In this study, the research team wanted to learn whether a new approach to self-manage urinary symptoms that may warn of infection was safe for patients using an intermittent catheter. In this approach, patients insert a probiotic through the catheter when they have urinary symptoms such as cloudy or smelly urine. Probiotics are healthy bacteria that may treat or prevent illness.

What were the results?

During the study, 59 adults and 5 children used the probiotic in response to symptoms. The approach was safe and well-tolerated. The number of adverse events reported by patients, such as irritation or infection, didn’t increase after using the probiotic. Patients who used the probiotic had fewer symptoms, including pain, fever, and cloudy or smelly urine. Other symptoms, such as fatigue or blood in urine, didn’t change.

Patients who didn’t use the probiotic had no change in the number of symptoms during the study.

Who was in the study?

The study included 96 adults and 7 children from across the United States who had spinal cord injuries, spina bifida, or multiple sclerosis. Of adults, 74 percent were white, 19 percent were African American, 4 percent were Asian, 1 percent were American Indian, and 2 percent were more than one race; 6 percent did not report ethnicity and 2 percent were Hispanic. The average age was 43, and 63 percent were men.

What did the research team do?

To develop this new approach, the research team partnered with patients with spinal cord conditions or their parents. These partners also taught patients in the study about using the probiotic.

The research team looked at three 6-month study periods. During the first and last periods, patients didn’t use the probiotic. During the middle period, patients used the probiotic if they had urinary symptoms.

Patients or caregivers completed weekly surveys about urinary symptoms. Every six months, patients filled out a survey asking if they would seek out or pay for the probiotic if insurance didn’t pay for it. Patients also reported any adverse events. To see if the approach was well-tolerated, the team looked at whether having an adverse event affected how likely patients were to pay for the probiotic.

What were the limits of the study?

The number of adults and children who used the probiotic in the study was small. As a result, the research team can’t say for sure how well it improved symptoms.

Future research could test probiotics for urinary symptoms with more adults and children who use catheters.

How can people use the results?

Researchers can use the results to plan larger studies of this approach.

Objective

To test a new self-management protocol using a probiotic instilled into the bladder to decrease urinary symptoms in people with neurogenic bladder from spinal cord injury, spina bifida, or multiple sclerosis for safety, tolerability, and efficacy

Study Design

This single-arm intervention study tested a self-management protocol for patients with spinal cord injury, spina bifida, or multiple sclerosis who used intermittent catheterization for neurogenic bladder. In this protocol, patients instilled an intravesical Lactobacillus rhamnosus GG (LGG) probiotic into their bladder in response to symptoms associated with infection, such as cloudy or foul-smelling urine. Patients with spinal cord injury and spina bifida and caregivers of children with spina bifida helped develop the self-management protocol and trained study participants on its use.

The study included 96 adults and 7 children with neurogenic bladder from across the United States who used intermittent catheterization. Of the adults, 74% were white, 19% were African American, 4% were Asian, 1% were American Indian, and 2% were more than one race; 6% did not report ethnicity and 2% were Hispanic. The average age was 43, and 63% were male.

Researchers collected data in three 6-month phases: baseline, intervention, and follow-up. Patients implemented the protocol and instilled LGG when indicated by symptoms only during the intervention phase.

Patients completed weekly surveys about their urinary symptoms. To assess symptom burden, researchers categorized symptoms into three types: clinically actionable symptoms like fever or abdominal pain; bladder-specific symptoms like bladder function and urine quality; and constitutional symptoms like fatigue or lethargy.

Every six months, patients completed a survey about their reported likelihood to seek and pay for the intervention. Researchers assessed tolerability by looking at the association between patient-reported adverse events and likelihood to pay.

Results

During the study, 59 adults and 5 children instilled LGG per the self-management protocol. Patients who instilled LGG had decreased symptom burden for actionable (p<0.001) and urine quality symptoms (p=0.01), but not for bladder function and constitutional symptoms. Of the patients who did not instill LGG, symptom burden did not change significantly throughout the phases of the study.

Among patients who instilled LGG, the number of patient-reported total and genitourinary adverse events did not differ significantly before and after instillation of LGG. Analysis did not suggest an association between total dose of LGG and adverse events, or between adverse events and likelihood to seek and pay for the intervention.

Limitations

The study design does not permit definitive conclusions about the effectiveness of the self-management protocol.

Conclusions and Relevance

In this study, using a self-management protocol for instillation of intravesical LGG was safe and well-tolerated in adult patients who use intermittent catheterization to manage neurogenic bladder from spinal cord injury, spina bifida, or multiple sclerosis.

Future Research Needs

Future research could test the effectiveness of the self-management protocol with larger numbers of adults and children who use intermittent catheterization.