Intravesical LGG VS Saline Bladder Wash RCT

• Status: Recruiting
• Trial end date: 2026-08-31
• Target enrollment: 0
• Participant gender: All

Summary

This is the first ever comparative effectiveness study of an antibiotic-sparing novel self-management intervention to prevent complicated urinary tract infection (UTI).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medstar Health Research Institute

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