Clinical trial
Intravesical Lactobacillus rhamnosusGG Versus Saline Bladder Wash: A Randomized, Controlled, Comparative Effectiveness Clinical Trial
Name
STUDY00004287
Description
This is the first ever comparative effectiveness study of an antibiotic-sparing novel self-management intervention to prevent complicated urinary tract infection (UTI).
Trial arms
Trial start
2022-06-13
Estimated PCD
2025-12-31
Trial end
2026-12-31
Status
Recruiting
Phase
Early phase I
Treatment
Lactobacillus RhamnosusGG
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, 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 then continue completing the USQNB-IC at the determined frequency for the phase.
Arms:
Intravesical Lactobacillus RhamnosusGG and Bladder Wash (Prophylaxis Phase), Intravesical Lactobacillus RhamnosusGG and Bladder Wash (Treatment Phase)
Other names:
Culturelle Probiotic LGG®
Saline bladder wash
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 then continue completing the USQNB-IC at the determined frequency for the phase.
Arms:
Intravesical Bladder Wash (Prophylaxis Phase), Intravesical Bladder Wash (Treatment Phase)
Size
120
Primary endpoint
International SCI Lower Urinary Tract Function Basic Data Set
Day 1
International SCI Core Data Set
Day 1
NINDS Medical History CDE
Day 1
NINDS Prior and Concomitant Medications CDE
Day 1
Urinary Symptom Questionnaire for Neurogenic Bladder-Intermittent Catheter
(SA1 and SA3) Weekly up to 18 months
Urinary Symptom Questionnaire for Neurogenic Bladder-Intermittent Catheter
(SA1) Day 1 post-instillation (Phase 2: treatment phase)
Urinary Symptom Questionnaire for Neurogenic Bladder-Intermittent Catheter
(SA1) Day 2 post-instillation (Phase 2: treatment phase)
Urinary Symptom Questionnaire for Neurogenic Bladder-Intermittent Catheter
(SA3) Twice weekly post-instillation for up to 6 months (Phase 3: prophylaxis phase)
Patient Satisfaction Survey
At final USQNB-IC completion (between 13 to 18 months) or at participant drop-out
Eligibility criteria
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 intravesical LGG®; and
9. Active cancer (or within 5 years) or active autoimmune disorder
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, controlled comparative effectiveness clinical trial.', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 120, 'type': 'ESTIMATED'}}
Updated at
2024-05-03
1 organization
2 products
2 indications
Organization
MedStar Health Research InstituteProduct
Lactobacillus Rhamnosus GGIndication
Spinal Cord InjuriesIndication
Neurogenic BladderProduct
Saline bladder wash