Intravesical LGG VS Saline Bladder Wash RCT

Launched by MEDSTAR HEALTH RESEARCH INSTITUTE · Jan 28, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to help prevent complicated urinary tract infections (UTIs) in people with spinal cord injuries and neurogenic bladder issues. The study compares a special treatment called intravesical LGG, which is a type of beneficial bacteria, to a standard saline bladder wash. The goal is to see if this new treatment can reduce the need for antibiotics while still keeping patients healthy.

To participate in the trial, you need to be at least 18 years old, have had a spinal cord injury for at least six months, and use intermittent catheterization to manage your bladder. It's important that you are living in the community and not hospitalized. However, if you have certain health issues, like kidney stones or are currently taking antibiotics, you may not be eligible. If you join the study, you’ll receive either the LGG treatment or the saline wash, and researchers will monitor your health to see how well the treatments work in preventing UTIs. This study is currently recruiting participants, so if you think you might be interested, talk to your healthcare provider for more information.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥18 years;
• • 2. SCI at least 6 months duration;
• • 3. NLUTD (as determined by their SCI physician or urologist);
• • 4. Utilizing intermittent catheterization for bladder management; and
• • 5. Community dwelling (discharged from the acute care setting).
• Exclusion Criteria:
• • 1. Known genitourinary pathology beyond neuropathic bladder (i.e., vesicoureteral reflux, bladder or kidney stones, etc.);
• • 2. Use of prophylactic antibiotics;
• • 3. Instillation of intravesical agents (e.g., gentamycin, saline; or Lactobacillus);
• • 4. Immunodeficiency;
• • 5. Any oral antibiotics within the past 2 weeks;
• • 6. Psychologic or psychiatric conditions influencing the ability to follow instructions;
• • 7. Participation in another study in which results would be confounded;
• • 8. 6 months since prior exposure to intravesical LGG®; and
• • 9. Active cancer (or within 5 years) or active autoimmune disorder