Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2025-12-26 @ 10:56 AM
NCT ID:
NCT03931408
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03931408
Study Brief:
Protocol Section:
NCT03931408