RecruitingPhase 2

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

United States182 participantsStarted 2020-01-10

Plain-language summary

The objectives of the proposed research among this population are: 1) to define clinically meaningful change (i.e. differentiating states of health and illness) with respect to urinary symptoms, urine inflammation, cultivable bacteria, and the urine ecosystem; and 2) to determine the optimal intravesical Lactobacillus RhamnosusGG (LGG®) dose to be used to reduce urinary symptoms in a future clinical trial.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter

Timeframe: (SA 1) day of urine collection

Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter

Timeframe: (SA 1) day 1 post urine collection

Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter

Timeframe: (SA 1) day 2 post urine collection

Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter

Timeframe: (SA 1) day 3 post urine collection

Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter

Timeframe: (SA 2) Weekly up to 29 months

Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter

Timeframe: (SA 2) day 1 of intervention (low or high dose)

Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter

Trial details

NCT IDNCT04323735

SponsorMedstar Health Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09

Contact for this trial

Amanda K Rounds, PhD

202-877-1591 Amanda.K.Rounds@medstar.net

View on ClinicalTrials.gov More Neurogenic Bladder trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter

Timeframe: (SA 1) day of urine collection

Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter

Timeframe: (SA 1) day 1 post urine collection

Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter

Timeframe: (SA 1) day 2 post urine collection

Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter

Timeframe: (SA 1) day 3 post urine collection

Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter

Timeframe: (SA 2) Weekly up to 29 months

Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter

Timeframe: (SA 2) day 1 of intervention (low or high dose)

Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter