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Intravesical Lactobacillus for Urinary Symptoms in Neurogenic Bladder

This study is investigating if a probiotic called Lactobacillus RhamnosusGG (LGG®, found in Culturelle 10 Billion CFU Capsules) can help reduce urinary symptoms in people with neurogenic bladder (a condition where nerve problems affect bladder control) who use indwelling catheters. Participants will mix the contents of one LGG capsule with sterile saline and instill it into their bladder. The main goal is to understand how urinary symptoms change and to find the best dose of LGG for future studies. You may be able to join if you are an adult with neurogenic bladder for at least six months, use an indwelling catheter, and live in the community. The study plans to enroll 182 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It aims to enroll 182 participants, but the phase and specific design (like randomized or blinded) are not specified.
What's involved
The study will measure your urinary symptoms using a questionnaire on the day of urine collection, and then one and two days after urine collection. Other specific procedures or visits are not detailed.
Compensation
Not stated in the trial record.
Follow-up
Your urinary symptoms will be assessed for two days after urine collection. Longer-term follow-up is not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04323735

Intravesical Lactobacillus for Urinary Symptoms Among People With NLUTD Who Use Indwelling Catheters

Active, Not Recruiting
PHASE2Ages 18+InterventionalPrevention
Medstar Health Research Institute
~182 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:Culturelle 10 Billion CFU Capsule

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter
Measured over (SA 1) day of urine collection
+34 more outcomes measured

Conditions

Neurogenic Bladder

Explore related trials

Neurogenic Bladder

Where it's being run

1 sites across 1 states
District of Columbia1

Study leadership

  • Suzanne Groah, MD, MSPH · PRINCIPAL_INVESTIGATOR · MedStar National Rehabilitation Hospital

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

Neurogenic bladder for at least 6 months;
Utilizing indwelling catheterization for bladder management;
Women must be premenopausal and not currently menstruating;
Community dwelling
physical disability

Exclusion

Use of prophylactic antibiotics;
Instillation of intravesical antimicrobials to prevent UTI;
Psychologic or psychiatric conditions influencing the ability to follow instructions;
Use of oral or IV antibiotics within the past 2 weeks;
Sexual activity within the previous 72 hours;
Participation in another study with which results could be confounded.

What this trial measures

  • Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter(SA 1) day of urine collection

    Will measure change in urinary symptoms for those that use an indwelling catheter. Higher score may mean worse outcomes. (local urine collection participants only)

  • Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter(SA 1) day 1 post urine collection

    Will measure change in urinary symptoms for those that use an indwelling catheter. Higher score may mean worse outcomes. (local urine collection participants only)

  • Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter(SA 1) day 2 post urine collection

    Will measure change in urinary symptoms for those that use an indwelling catheter. Higher score may mean worse outcomes. (local urine collection participants only)

  • Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter(SA 1) day 3 post urine collection

    Will measure change in urinary symptoms for those that use an indwelling catheter. Higher score may mean worse outcomes. (local urine collection participants only)

  • Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter(SA 2) Weekly up to 29 months

    Will measure change in urinary symptoms for those that use an indwelling catheter. Higher score may mean worse outcomes

  • Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter(SA 2) day 1 of intervention (low or high dose)

    Will measure change in urinary symptoms for those that use an indwelling catheter. Higher score may mean worse outcomes. (local urine collection participants only)

  • Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter(SA 2) day 2 of intervention (low or high dose)

    Will measure change in urinary symptoms for those that use an indwelling catheter. Higher score may mean worse outcomes

  • Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter(SA 2) day 3 of intervention (low or high dose)

    Will measure change in urinary symptoms for those that use an indwelling catheter. Higher score may mean worse outcomes

  • Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter(SA 2) day 4 of intervention (low or high dose)

    Will measure change in urinary symptoms for those that use an indwelling catheter. Higher score may mean worse outcomes

  • Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter(SA 2) day 5 of intervention (high dose only)

    Will measure change in urinary symptoms for those that use an indwelling catheter. Higher score may mean worse outcomes

  • Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter(SA 2) 24-48 hours after intervention completion

    Will measure change in urinary symptoms for those that use an indwelling catheter. Higher score may mean worse outcomes. (local urine collection participants only)

  • Change in Urine white blood cell count(SA 1) day 1 post urine collection

    urinalysis. (local urine collection participants only)

  • Change in Urine white blood cell count(SA 1) day 14 post urine collection

    urinalysis. (local urine collection participants only)

  • Change in Urine white blood cell count(SA 2) day 1 of intervention

    urinalysis. (local urine collection participants only)

  • Change in Urine white blood cell count(SA 2) 24-48 hours after intervention completion

    urinalysis. (local urine collection participants only)

  • Change in Urine Nitrite(SA 1) day 1 post urine collection

    urinalysis. (local urine collection participants only)

  • Change in Urine Nitrite(SA 1) day 14 post urine collection

    urinalysis. (local urine collection participants only)

  • Change in Urine Nitrite(SA 2) day 1 of intervention

    urinalysis. (local urine collection participants only)

  • Change in Urine Nitrite(SA 2) 24-48 hours after intervention completion

    urinalysis. (local urine collection participants only)

  • Change in Urine NGAL(SA 1) day 1 post urine collection

    Urine NGAL. (local urine collection participants only)

  • Change in Urine NGAL(SA 1) day 14 post urine collection

    Urine NGAL. (local urine collection participants only)

  • Change in Urine NGAL(SA 2) day 1 of intervention

    Urine NGAL. (local urine collection participants only)

  • Change in Urine NGAL(SA 2) 24-48 hours after intervention completion

    Urine NGAL. (local urine collection participants only)

  • Change in Cultivable Bacteria(SA 1) day 1 post urine collection

    urine culture. (local urine collection participants only)

  • Change in Cultivable Bacteria(SA 1) day 14 post urine collection

    urine culture. (local urine collection participants only)

  • Change in Cultivable Bacteria(SA 2) day 1 of intervention

    urine culture. (local urine collection participants only)

  • Change in Cultivable Bacteria(SA 2) 24-48 hours after intervention completion

    urine culture. (local urine collection participants only)

  • Change in Urine microbiome composition and function(SA 1) day 1 post urine collection

    Next generation sequencing for microbiome composition. (local urine collection participants only)

  • Change in Urine microbiome composition and function(SA 1) day 14 post urine collection

    Next generation sequencing for microbiome composition. (local urine collection participants only)

  • Change in Urine microbiome composition and function(SA 2) day 1 of intervention

    Next generation sequencing for microbiome composition. (local urine collection participants only)

  • Change in Urine microbiome composition and function(SA 2) 24-48 hours after intervention completion

    Next generation sequencing for microbiome composition. (local urine collection participants only)

  • NINDS Medical History CDE:Baseline

    A brief medical history using body system categories

  • Medical History FormBaseline

    Medical history of participant

  • International SCI Lower Urinary Tract Function Basic Data SetBaseline

    A tool to describe urinary tract impairment, awareness of need to empty the bladder, main bladder emptying method, medications used for bladder management, surgeries, and change in urinary symptoms in the past year.

  • NINDS Prior and Concomitant Medications CDEBaseline

    Contains whether or not the participant is taking a medication during the study protocol, name of medication, reason for medication, medication dose, frequency, start and end dates, and free text