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 range18 Years

SexALL

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.

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

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

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 range18 Years

SexALL

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

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