Gentamicin Bladder Instillations to Prevent Urinary Tract Infections in Patients With Spinal Cord… (NCT03503513) | Clinical Trial Compass
CompletedPhase 2/3
Gentamicin Bladder Instillations to Prevent Urinary Tract Infections in Patients With Spinal Cord Injury
United States23 participantsStarted 2018-08-24
Plain-language summary
A non-randomized study evaluating the efficacy of intravesical gentamicin on the occurrence rate of urinary tract infections and bladder complications in patients after spinal cord injury (SCI), and to assess its effectiveness in promoting overall quality of life (QOL), community living, and participation.
Who can participate
Age range
18 Years – 80 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:
* Provision of signed and dated informed consent form and agreement to complete the daily dosing log as instructed by the study coordinator.
* History of traumatic spinal cord injury (SCI) or non-traumatic spinal cord disease, (SCD) with sustained neurological dysfunction
* At least 6 months post-initial hospital discharge following SCI/SCD onset
* Neurogenic bladder
* Ability to perform daily instillation on self or with help of others and willingness to adhere to the study regiment.
* History of at least 2 documented urinary tract infection (UTI) during the previous 6 months (prior to screening)
* Have a designated physician or health care provider for routine care
* Use of clean intermittent catheterization or catheterization through a stoma (i.e. Mitrofanoff) as their primary method of bladder management
Exclusion Criteria:
* Concurrent use of systemic oral or intravesical antibiotic prophylaxis
* Documented or self-reported history of gentamicin allergy
* Female patients who are currently pregnant or attempting to become pregnant
* Patients with a history of 8th cranial nerve disorder
* Co-morbidities like cancer and chronic disease that could impact patient safety OR significantly affect the rate of UTIs and/or quality of life (QOL) substantially
* Urological co-morbidities like bladder cancer and history of kidney disease.
* Current UTI at screening (assessed via urine analysis and culture and symptoms)
* Concurrent enrollment in a similar clinic…
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
1
Number of Urinary Tract Infections (UTI) Over Time
Timeframe: 6 months prior to treatment and 6 months during treatment