Recruiting

Phase 2

Self-Management InterventionIntravesical LGG VS Saline Bladder Wash RCT

Sponsor:

Medstar Health Research Institute

Code:

NCT05230511

Conditions

Spinal Cord Injuries

Neurogenic Bladder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Lactobacillus RhamnosusGG

Saline bladder wash

Study Details

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

Study ID

NCT05230511

Start date

Jun 13, 2022

Status verified date

Aug, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Jul 31, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Intravesical Lactobacillus RhamnosusGG and Bladder Wash (Treatment 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.

other: Intravesical Bladder Wash (Treatment Phase)

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.

experimental: Intravesical Lactobacillus RhamnosusGG and 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. 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.

other: Intravesical Bladder Wash (Prophylaxis Phase)

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.

Interventions

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.

Primary outcome measure

International SCI Lower Urinary Tract Function Basic Data Set [ Time Frame: Day 1 ]
International SCI Core Data Set [ Time Frame: Day 1 ]
NINDS Medical History CDE [ Time Frame: Day 1 ]
NINDS Prior and Concomitant Medications CDE [ Time Frame: Day 1 ]
Urinary Symptom Questionnaire for Neurogenic Bladder-Intermittent Catheter [ Time Frame: (SA1 and SA3) Weekly up to 18 months ]
Urinary Symptom Questionnaire for Neurogenic Bladder-Intermittent Catheter [ Time Frame: (SA1) Day 1 post-instillation (Phase 2: treatment phase) ]
Urinary Symptom Questionnaire for Neurogenic Bladder-Intermittent Catheter [ Time Frame: (SA1) Day 2 post-instillation (Phase 2: treatment phase) ]
Urinary Symptom Questionnaire for Neurogenic Bladder-Intermittent Catheter [ Time Frame: (SA3) Twice weekly post-instillation for up to 6 months (Phase 3: prophylaxis phase) ]
Patient Satisfaction Survey [ Time Frame: At final USQNB-IC completion (between 13 to 18 months) or at participant drop-out ]

Central Contacts and Locations

Central contacts

Emily Leonard, PhD

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

Inger H Ljungberg, MPH

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

Locations

MedStar National Rehabilitation Hospital

Recruiting

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

Contacts

Allison M Maxwell, BA

(202) 877-1560 allison.m.maxwell@medstar.net

Inger H Ljungberg, MPH

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

Principal Investigator:

Suzanne Groah, MD, MSPH

More Information

Sponsor

Medstar Health Research Institute

Last update posted

Aug 29, 2025

Last verified

Aug, 2025

Keywords

Intermittent Catheter

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Medstar Health Research Institute on 2025-08-29.