Intravesical LGG VS Saline Bladder Wash RCT
Spinal Cord Injuries, Neurogenic Bladder
About this trial
This is an interventional prevention trial for Spinal Cord Injuries focused on measuring Intermittent Catheter
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- MedStar National Rehabilitation HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Other
Experimental
Other
Intravesical Lactobacillus RhamnosusGG and Bladder Wash (Treatment Phase)
Intravesical Bladder Wash (Treatment Phase)
Intravesical Lactobacillus RhamnosusGG and Bladder Wash (Prophylaxis Phase)
Intravesical Bladder Wash (Prophylaxis Phase)
LGG® (Culturelle Probiotic LGG®) will be used. This is the product we have used in the past and for which we have demonstrated safety, tolerability, and preliminary efficacy. For the LGG® instillation in response to trigger symptoms, participants will be instructed to mix the contents of 1 LGG® capsule into 45 cc sterile 0.9% saline. After mixing, participants will draw up the 45cc liquid LGG® mixture into a 60cc syringe and instill via the intermittent catheter after the last catheterization prior to going to bed. Participants will be asked to return any remaining capsules at the end of the study. Participants will be instructed to complete the USQNB-IC at the time of symptoms (in real time) and daily during instillations for 2 days after the final instillation. Subjects will remain in this phase 6 months.
Participants will draw up the 45cc of normal saline into a 60cc syringe and instill via the intermittent catheter after the last catheterization prior to going to bed after trigger symptoms occur. Participants will be instructed to complete the USQNB-IC at the time of symptoms (in real time) and daily during instillations for 2 days after the final instillation. Subjects will remain in this phase 6 months.
LGG® (Culturelle Probiotic LGG®) will be used. This is the product we have used in the past and for which we have demonstrated safety, tolerability, and preliminary efficacy. For the LGG® instillation in response to trigger symptoms, participants will be instructed to mix the contents of 1 LGG® capsule into 45 cc sterile 0.9% saline. After mixing, participants will draw up the 45cc liquid LGG® mixture into a 60cc syringe and instill via the intermittent catheter after the last catheterization prior to going to bed. They will then instill the LGG® mixture every 2 days for the remainder of the 6 months. Participants will be asked to return any remaining capsules at the end of the study. Participants will be instructed to complete the USQNB-IC at the time of symptoms (in real time) and biweekly post-instillation. Subjects will remain in this phase 6 months.
Participants will draw up the 45cc of normal saline into a 60cc syringe and instill via the intermittent catheter after the last catheterization prior to going to bed after trigger symptoms occur. They will then instill the saline BW every 2 days for the remainder of the 6 months. Participants will be instructed to complete the USQNB-IC at the time of symptoms (in real time) and biweekly post-instillation. Subjects will remain in this phase 6 months.