Intravesical LGG VS Saline Bladder Wash RCT
This is the first ever comparative effectiveness study of an antibiotic-sparing novel self-management intervention to prevent complicated urinary tract infection (UTI).
| Condition(s) | Spinal Cord Injuries, Neurogenic Bladder |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | This is the first ever comparative effectiveness study of an antibiotic-sparing novel self-management intervention to prevent complicated urinary tract infection (UTI). |
| Who can participate | 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 |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Medstar Health Research Institute |
| Locations | Washington D.C., District of Columbia, United States |
| Start date | 2022-06-13 |
| NCT ID | NCT05230511 |
| Official listing | https://clinicaltrials.gov/study/NCT05230511 |