Status:
COMPLETED
Intravesical Lactobacillus to Reduce Urinary Symptoms After Spinal Cord Injury
Lead Sponsor:
Medstar Health Research Institute
Collaborating Sponsors:
Children's National Research Institute
Conditions:
Spinal Cord Injuries
Neurogenic Bladder
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The objectives of the proposed research among this population are: 1) to define clinically meaningful change (i.e. differentiating states of health and illness) with respect to urinary symptoms, urine...
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
- SCI at least 1-year duration;
- Neurogenic bladder;
- Utilizing intermittent catheterization for bladder management;
- Women must be premenopausal and not currently menstruating;
- Community dwelling
Exclusion
- Use of prophylactic antibiotics;
- Instillation of intravesical antimicrobials to prevent UTI;
- Psychologic or psychiatric conditions influencing the ability to follow instructions;
- Use of oral or IV antibiotics within the past 2 weeks;
- Sexual activity within the previous 72 hours;
- Participation in another study with which results could be confounded.
Key Trial Info
Start Date :
May 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 14 2025
Estimated Enrollment :
182 Patients enrolled
Trial Details
Trial ID
NCT04373512
Start Date
May 20 2020
End Date
February 14 2025
Last Update
May 13 2025
Active Locations (1)
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1
MedStar National Rehabilitation Hospital
Washington D.C., District of Columbia, United States, 20010