LGG vs. Saline Bladder Wash for Neurogenic Bladder in Spinal Cord Injury
This study is comparing two ways to prevent complicated urinary tract infections (UTIs) in people with spinal cord injuries (SCI) and neurogenic bladder (NLUTD), which means their bladder doesn't work properly due to nerve damage. You might be able to join if you are at least 18 years old, have had an SCI for at least 6 months, and use a catheter to manage your bladder. The study is testing whether using Lactobacillus RhamnosusGG (LGG®), a probiotic, as a bladder wash is more effective than a saline (saltwater) bladder wash. Success will be measured by looking at your bladder function and overall health information. The study plans to enroll 120 participants, but its current recruitment status is unclear.
- Study design
- This is an interventional study comparing two different bladder washes. It plans to enroll 120 participants.
- What's involved
- Participants will be instructed to mix and instill either LGG® or saline into their bladder using an intermittent catheter. They will also complete a questionnaire when symptoms occur.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your bladder function and health information will be measured at Day 1 of the study.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Intravesical LGG VS Saline Bladder Wash RCT
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Suzanne Groah, MD, MSPH · PRINCIPAL_INVESTIGATOR · MedStar National Rehabilitation Hospital
Who to contact
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What this trial measures
- International SCI Lower Urinary Tract Function Basic Data SetDay 1
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.
- International SCI Core Data SetDay 1
Includes date of injury, dates of initial hospitalization admission and discharge, neurological data. Score is not associated with outcome.
- NINDS Medical History CDEDay 1
A brief medical history using body system categories. Score is not associated with outcomes.
- NINDS Prior and Concomitant Medications CDEDay 1
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.
- Urinary Symptom Questionnaire for Neurogenic Bladder-Intermittent Catheter(SA1 and SA3) Weekly up to 18 months
Will measure change in urinary symptoms for those that use an intermittent catheter. Higher scores may mean worse outcomes.
- Urinary Symptom Questionnaire for Neurogenic Bladder-Intermittent Catheter(SA1) Day 1 post-instillation (Phase 2: treatment phase)
Will measure change in urinary symptoms for those that use an intermittent catheter. Higher scores may mean worse outcomes.
- Urinary Symptom Questionnaire for Neurogenic Bladder-Intermittent Catheter(SA1) Day 2 post-instillation (Phase 2: treatment phase)
Will measure change in urinary symptoms for those that use an intermittent catheter. Higher scores may mean worse outcomes.
- Urinary Symptom Questionnaire for Neurogenic Bladder-Intermittent Catheter(SA3) Twice weekly post-instillation for up to 6 months (Phase 3: prophylaxis phase)
Will measure change in urinary symptoms for those that use an intermittent catheter. Higher scores may mean worse outcomes.
- Patient Satisfaction SurveyAt final USQNB-IC completion (between 13 to 18 months) or at participant drop-out
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?"