Intravesical LGG VS Saline Bladder Wash RCT

Recruiting now · Phase 2

Conditions studied: Spinal Cord Injuries, Neurogenic Bladder

In brief

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

Key facts

Study ID

NCT05230511

Run by

Medstar Health Research Institute

People needed

120

Starts

2022-06-13

Expected to finish

2026-12-31

Last updated by the study team

2025-08-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥18 years;
• SCI at least 6 months duration;
• NLUTD (as determined by their SCI physician or urologist);
• Utilizing intermittent catheterization for bladder management; and
• Community dwelling (discharged from the acute care setting).

You may not qualify if…

• Known genitourinary pathology beyond neuropathic bladder (i.e., vesicoureteral reflux, bladder or kidney stones, etc.);
• Use of prophylactic antibiotics;
• Instillation of intravesical agents (e.g., gentamycin, saline; or Lactobacillus);
• Immunodeficiency;
• Any oral antibiotics within the past 2 weeks;
• Psychologic or psychiatric conditions influencing the ability to follow instructions;
• Participation in another study in which results would be confounded;
• 6 months since prior exposure to intravesical LGG®; and
• Active cancer (or within 5 years) or active autoimmune disorder

Where it is running

• MedStar National Rehabilitation Hospital — Washington D.C., District of Columbia, United States (enrolling)

Full record on ClinicalTrials.gov

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