Clinical trial NCT05230511: Intravesical LGG VS Saline Bladder Wash RCT
Official title: Intravesical Lactobacillus rhamnosusGG Versus Saline Bladder Wash: A Randomized, Controlled, Comparative Effectiveness Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Spinal Cord Injuries
Neurogenic Bladder
Keywords: Intermittent Catheter
Lead sponsor: Medstar Health Research Institute
Sponsor class: OTHER
First posted: 2022-02-09
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, controlled comparative effectiveness clinical trial.
Primary purpose: PREVENTION

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 condition, cause for emergency room visits, and infectious cause of hospitalization. Despite its prevalence, attempts to ameliorate UTI among people with SCI are stymied by long-standing diagnostic challenges which arise from evidence gaps around "gold standard" diagnostic tests (urinalysis and urine culture) that have lower sensitivity and specificity for UTI in this population. A high prevalence of chronic inflammation leading to persistence of white blood cells (WBC) in the urine confounds the utility of WBC count, pyuria, and leukocyte esterase as biomarkers for UTI; nitrites in urine indicate the presence of only specific (but not all) organisms, many of which are present to a greater extent in the urine of people with SCI; and people with SCI have a high prevalence of asymptomatic bacteriuria. These physiologic changes render the gold standard diagnostic tests less useful for identifying UTI in persons with SCI.

SPECIFIC AIM 1 Compare the effects of Lactobacillus Rhamnosus GG (LGG®) + Saline bladder wash (BW) versus BW alone on USQNB-determined bladder (B1) and urine quality (B2) symptom burden (two co-primary outcomes) where participants self-manage in response to two trigger symptoms (cloudier and/or more foul-smelling urine).

SPECIFIC AIM 2 Compare the effects of LGG®+BW versus BW alone (in response to the two trigger symptoms) on key secondary outcomes: number of days lost from rehabilitation, work, and/or school; number of days symptomatic; number of interactions with the health care system due to urinary symptoms; exposure to antibiotics (days, volume).

SPECIFIC AIM 3 Compare the prophylactic effects of LGG®+BW versus BW alone on USQNB-determined bladder (B1) and urine quality (B2) symptom burden.

SPECIFIC AIM 4 Compare the prophylactic effects of LGG®+BW versus BW alone on key secondary outcomes: number of days lost from rehabilitation, work, and/or school; number of days symptomatic; number of interactions with the health care system due to urinary symptoms; exposure to antibiotics (days, volume).

SPECIFIC AIM 5 Compare satisfaction of participants who instilled LGG®+BW to satisfaction of those who instilled BW only and determine if dropouts are differentially attributable to either intervention being perceived by participants as "not working".

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

Primary outcomes:
measure: International SCI Lower Urinary Tract Function Basic Data Set
timeFrame: Day 1
measure: International SCI Core Data Set
timeFrame: Day 1
measure: NINDS Medical History CDE
timeFrame: Day 1
measure: NINDS Prior and Concomitant Medications CDE
timeFrame: Day 1
measure: Urinary Symptom Questionnaire for Neurogenic Bladder-Intermittent Catheter
timeFrame: (SA1 and SA3) Weekly up to 18 months
measure: Urinary Symptom Questionnaire for Neurogenic Bladder-Intermittent Catheter
timeFrame: (SA1) Day 1 post-instillation (Phase 2: treatment phase)
measure: Urinary Symptom Questionnaire for Neurogenic Bladder-Intermittent Catheter
timeFrame: (SA1) Day 2 post-instillation (Phase 2: treatment phase)
measure: Urinary Symptom Questionnaire for Neurogenic Bladder-Intermittent Catheter
timeFrame: (SA3) Twice weekly post-instillation for up to 6 months (Phase 3: prophylaxis phase)
measure: Patient Satisfaction Survey
timeFrame: At final USQNB-IC completion (between 13 to 18 months) or at participant drop-out
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: MedStar National Rehabilitation Hospital
state: District of Columbia
Study officials:
affiliation: MedStar National Rehabilitation Hospital
name: Suzanne Groah, MD, MSPH
role: PRINCIPAL_INVESTIGATOR
References: