Recruiting

Lactobacillus & Gentamicin

Sponsor:

Medstar Health Research Institute

Code:

NCT07390591

Conditions

Spinal Cord Injuries

Neurogenic Lower Urinary Tract Dysfunction

Neurogenic Bladder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

The goal of this observational qualitative study is to learn about the experiences and perspectives of patients with neurogenic lower urinary tract dysfunction (NLUTD) and their caregivers regarding different types of intravesical instillations used for urinary health. The study aims to understand the perceived benefits, challenges, and opportunities related to Lactobacillus-only, gentamicin-only, and combined gentamicin-Lactobacillus instillations. The main question this study seeks to answer is:

1\. Determine patient and caregivers' preferences, and overall experiences regarding intravesical therapeutics for urinary symptoms and UTI

Researchers will compare responses from four groups: participants who have used Lactobacillus-only instillations, gentamicin-only instillations, combined gentamicin-Lactobacillus instillations, and caregivers who have experience supporting instillations.

Participants will take part in a one-hour semi-structured interview and may be contacted for brief follow-up discussions to clarify findings. Interviews will be audio-recorded, transcribed, and analyzed using qualitative data software to identify themes related to treatment preferences and acceptability.

Conditions

Spinal Cord Injuries

Neurogenic Lower Urinary Tract Dysfunction

Neurogenic Bladder

Study ID

NCT07390591

Start date

Jun 19, 2025

Status verified date

Dec, 2025

Completion date

Sep, 2027

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Criteria for patients:

  • Age 18+
  • Diagnosis of NLUTD
  • Chronic catheter usage (minimum 6 months), either intermittent catheterization or indwelling catheter
  • Community-dwelling
  • Experience using intravesical Lactobacillus, gentamicin, or combination of the two

Criteria for caregivers:

  • Age 18+
  • Care for patient with diagnosis of NLUTD
  • Care for patient who has used catheters chronically (minimum 6 months)
  • Experience facilitating patients' use of intravesical Lactobacillus, gentamicin, or combination of the two

Exclusion Criteria:

  • Psychiatric or psychologic conditions impacting ability to consent

Study Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Advancing intravesical instillation for urinary health [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Locations

Medstar National Rehabilitation Hospital

Recruiting

Washington D.C., District of Columbia, United States, 20010

Contacts

More Information

Sponsor

Medstar Health Research Institute

Last update posted

Feb 5, 2026

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Medstar Health Research Institute on 2026-02-05.