Intravesical LGG VS Saline Bladder Wash RCT

Spinal Cord Injuries Clinical Trial

Official title:

Intravesical Lactobacillus rhamnosusGG Versus Saline Bladder Wash: A Randomized, Controlled, Comparative Effectiveness Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05230511
• Other study ID #: STUDY00004287
• Status: Recruiting
• Phase: Phase 2
• Start date: June 13, 2022
• Est. completion date: December 31, 2026

Study information

• Verified date: May 2024
• Source: Medstar Health Research Institute
• Contact: Emily Leonard, PhD
• Phone: (202) 877-1844
• Email: emily.m.leonard[@]medstar.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is the first ever comparative effectiveness study of an antibiotic-sparing novel self-management intervention to prevent complicated urinary tract infection (UTI).

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".

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neurogenic Bladder
• Spinal Cord Injuries
• Urinary Bladder, Neurogenic

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
United States	MedStar National Rehabilitation Hospital	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Medstar Health Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	International SCI Lower Urinary Tract Function Basic Data Set	A tool that describes urinary tract impairment, awareness of need to empty bladder, main bladder emptying method, medications used for bladder management, surgeries, and change in urinary symptoms in the past year. Score is not associated with outcome.	Day 1
Primary	International SCI Core Data Set	Includes date of injury, dates of initial hospitalization admission and discharge, neurological data. Score is not associated with outcome.	Day 1
Primary	NINDS Medical History CDE	A brief medical history using body system categories. Score is not associated with outcomes.	Day 1
Primary	NINDS Prior and Concomitant Medications CDE	Contains whether or not the participant is taking a medication during the study protocol, name of the medication, reason for medication, medication dose, frequency, start and end dates, and free text. Score is not associated with outcomes.	Day 1
Primary	Urinary Symptom Questionnaire for Neurogenic Bladder-Intermittent Catheter	Will measure change in urinary symptoms for those that use an intermittent catheter. Higher scores may mean worse outcomes.	(SA1 and SA3) Weekly up to 18 months
Primary	Urinary Symptom Questionnaire for Neurogenic Bladder-Intermittent Catheter	Will measure change in urinary symptoms for those that use an intermittent catheter. Higher scores may mean worse outcomes.	(SA1) Day 1 post-instillation (Phase 2: treatment phase)
Primary	Urinary Symptom Questionnaire for Neurogenic Bladder-Intermittent Catheter	Will measure change in urinary symptoms for those that use an intermittent catheter. Higher scores may mean worse outcomes.	(SA1) Day 2 post-instillation (Phase 2: treatment phase)
Primary	Urinary Symptom Questionnaire for Neurogenic Bladder-Intermittent Catheter	Will measure change in urinary symptoms for those that use an intermittent catheter. Higher scores may mean worse outcomes.	(SA3) Twice weekly post-instillation for up to 6 months (Phase 3: prophylaxis phase)
Primary	Patient Satisfaction Survey	We developed a simple three-item patient satisfaction "survey" that will be requested from only those individuals who used the intervention (LGG® +BW or BW only) at the time of final USQNB-IC completion, or at the drop out visit (for those who did use the intervention at least once). Participants will be asked to estimate, using a scale from 0% How satisfied with the intervention you used are you?; Would you seek this intervention out and pay for it if insurance did not pay for it?; Would you use or recommend the intervention in response to symptoms, prophylactically, or both? :At the drop out visit, we will ask these three questions and one additional item for those who used the intervention at least once, "Are you dropping out because the intervention was not working for you?"	At final USQNB-IC completion (between 13 to 18 months) or at participant drop-out