CompletedPhase 2

Gentamicin Bladder Instillation in Individuals With Spinal Cord Injury Having Chronic Urinary Tract Infections

United States6 participantsStarted 2019-02-19

Plain-language summary

Participants will undergo daily gentamicin bladder instillations to determine if its use will reduce the rate of symptomatic urinary tract infections (UTIs) as well as the use of oral and intravenous antibiotics in adults with chronic spinal cord injury (SCI) who have recurrent UTIs. Participants are randomized into one of three groups: 1) Gentamicin and saline instillation 2) Saline only instillation 3) Standard of care, no instillation.

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: * At least 18 years of age; * Non-progressive spinal cord injury; * Stable medical condition; * Bladder dysfunction as a result of spinal cord injury * History of recurrent UTIs (defined as 3 or more within the past year or 2 or more within the past 6 months). Exclusion Criteria: * Signs or symptoms of serious UTI that requires the use of systemic antibiotics; * Use of any urine-acidifying agent, bladder irrigant, or systemic antibiotic within the previous 2 weeks; * Participants colonized with gentamicin-resistant bacteria on baseline urine culture or a gentamicin allergy/sensitivity; * Participants with known hearing loss and/or renal disease; * Pregnant at the time of enrollment or planning to become pregnant during the time course of the study.

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

Evaluate Bladder Storage Using Urodynamics

Timeframe: 1. Baseline (1 week) 2. Midpoint (2 months) 3. Post (4 months)

Trial details

NCT IDNCT03931408

SponsorUniversity of Louisville

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-07-14

Results submitted2024-04-30

View on ClinicalTrials.gov More Neurogenic Bladder trials