Using Lactobacillus to Improve Urinary Symptoms in People with Neurogenic Bladder

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

This study is testing if a special probiotic called Lactobacillus can help people with neurogenic bladder who use catheters feel better by reducing their urinary symptoms.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 182 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Medstar Health Research Institute (other)
• Locations: 1 site (Washington D.C., District of Columbia)
• Trial ID: NCT04323735 on ClinicalTrials.gov

What this trial studies

This research aims to evaluate the effectiveness of intravesical Lactobacillus Rhamnosus GG (LGG®) in reducing urinary symptoms among individuals with neurogenic bladder who use indwelling catheters. The study will assess clinically meaningful changes in urinary symptoms, urine inflammation, and the urinary microbiome. It will also determine the optimal dosage of LGG to be used in future clinical trials. The study addresses the challenges of diagnosing urinary tract infections in this population, which often experience chronic inflammation and asymptomatic bacteriuria.

Who should consider this trial

Good fit: Ideal candidates include individuals with neurogenic bladder for at least six months who are using indwelling catheters and are community-dwelling.

Not a fit: Patients currently using prophylactic antibiotics or intravesical antimicrobials, or those with certain psychological conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce urinary symptoms and improve the quality of life for patients with neurogenic bladder.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in using probiotics for urinary health, indicating potential for success.

Eligibility criteria

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.

Where this trial is running

Washington D.C., District of Columbia

• MedStar National Rehabilitation Hospital — Washington D.C., District of Columbia, United States (RECRUITING)

Study contacts

• Principal investigator: Suzanne Groah, MD, MSPH — MedStar National Rehabilitation Hospital
• Study coordinator: Amanda K Rounds, PhD

Conditions: Neurogenic Bladder, Indwelling catheter, Foley catheter, Suprapubic Catheter