Intravesical LGG VS Saline Bladder Wash RCT

NCT05230511 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: STUDY00004287
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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).

Conditions

Spinal Cord Injuries; Neurogenic Bladder

Keywords

Intermittent Catheter

Outcome Measures

Primary Outcomes (9)

• 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

• 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

• NINDS Medical History CDE

  A brief medical history using body system categories. Score is not associated with outcomes.

  Day 1

• 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

• 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

• 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)

• 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)

• 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)

• 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% \<totally dissatisfied/would absolutely never do this\>, through 50% \<neither satisfied nor dissatisfied/might do this\> to 100% \<completely satisfied/would absolutely always do this\>: 1. How satisfied with the intervention you used are you? 2. Would you seek this intervention out and pay for it if insurance did not pay for it? 3. 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

Study Arms (4)

Intravesical Lactobacillus RhamnosusGG and Bladder Wash (Treatment Phase)

EXPERIMENTAL

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.

Drug: Lactobacillus RhamnosusGG

Intravesical Bladder Wash (Treatment Phase)

OTHER

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.

Drug: Saline bladder wash

Intravesical Lactobacillus RhamnosusGG and Bladder Wash (Prophylaxis Phase)

EXPERIMENTAL

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.

Drug: Lactobacillus RhamnosusGG

Intravesical Bladder Wash (Prophylaxis Phase)

OTHER

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.

Drug: Saline bladder wash

Interventions

Lactobacillus RhamnosusGG DRUG

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.

Also known as: Culturelle Probiotic LGG®

Intravesical Lactobacillus RhamnosusGG and Bladder Wash (Prophylaxis Phase); Intravesical Lactobacillus RhamnosusGG and Bladder Wash (Treatment Phase)

Saline bladder wash DRUG

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.

Intravesical Bladder Wash (Prophylaxis Phase); Intravesical Bladder Wash (Treatment Phase)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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;
• months since prior exposure to intravesical LGG®; and
• Active cancer (or within 5 years) or active autoimmune disorder

Sponsors & Collaborators

• Medstar Health Research Institute: lead

Study Sites (1)

MedStar National Rehabilitation Hospital

Washington D.C., District of Columbia, 20010, United States

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries; Urinary Bladder, Neurogenic

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Neurologic Manifestations; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Suzanne Groah, MD, MSPH

  MedStar National Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emily Leonard, PhD

CONTACT

(202) 877-1844; emily.m.leonard@medstar.net

Inger H Ljungberg, MPH

CONTACT

(202) 877-1694; inger.h.ljungberg@medstar.net

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, controlled comparative effectiveness clinical trial.

Study Record Dates

• First Submitted: January 28, 2022
• First Posted: February 9, 2022
• Study Start: June 13, 2022
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 29, 2025

Record last verified: 2025-08

Locations

US (1)