Status:
RECRUITING
Intravesical LGG VS Saline Bladder Wash RCT
Lead Sponsor:
Medstar Health Research Institute
Conditions:
Spinal Cord Injuries
Neurogenic Bladder
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is the first ever comparative effectiveness study of an antibiotic-sparing novel self-management intervention to prevent complicated urinary tract infection (UTI).
Detailed Description
Urinary tract infection (UTI) is the most common outpatient infection world-wide, and for people with spinal cord injury (SCI) and neurogenic bladder (NB), it is the most common infection, secondary c...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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
Key Trial Info
Start Date :
June 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT05230511
Start Date
June 13 2022
End Date
December 31 2026
Last Update
August 29 2025
Active Locations (1)
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1
MedStar National Rehabilitation Hospital
Washington D.C., District of Columbia, United States, 20010