Clinical trial NCT03503513: Gentamicin Bladder Instillations to Prevent Urinary Tract Infections in Patients With Spinal Cord Injury
Official title: The Effect of Gentamicin Intravesical Installations on Decreasing Urinary Tract Infections in Patients With Neurogenic Bladder After Spinal Cord Injury: A Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Urinary Tract Infections
Spinal Cord Injuries
Spinal Cord Diseases
Neurogenic Bladder
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Department of Health and Human Services
First posted: 2018-04-19
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: For each participant, six month pre-treatment data is compared to data collected during treatment (count of UTIs) and immediately after treatment (self-reported measures).
Primary purpose: PREVENTION

Brief 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.

Detailed description: Intervention: Participants' number of UTIs during the six-month treatment period will be compared to the number they incurred during the six months prior to treatment. Participants complete a baseline visit which consists of medical history, informed consent, urinalysis/culture indicating no active UTIs, metabolic panel, and self-reported measures about complications, symptoms, community participation and quality of life. Similar information is collected at the end of treatment. At a 3-month follow up visit, all available data is obtained through phone interviews and/or medical chart reviews except for self-report measures. Participants begin active treatment using Gentamicin plus saline solution after they have completed all requirements. Instillations of treatment solution occur nightly after the participant's last evening catheterization. Bi-weekly calls are conducted to ensure compliance, answer questions and document adverse events. Participants will stop the trial if they develop an UTI. After receiving treatment for the UTI by their physician, they will go into a washout period of a week before resuming the trial with Gentamicin instillations.

Eligibility criteria: 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 clinical trial
* Concurrent use of contraindicated diuretics (ethacrynic acid, furosemide)
* Current use of other contraindicated or disallowed concomitant medications or receiving treatments that may influence the results from this study.
* Known allergy to aminoglycoside antibiotics; Otological symptoms at baseline (i.e. tinnitus. severe dizziness/vertigo)
* At the discretion of study team, individuals who are unable or unlikely to comply with procedures and/or for whom study participation is not recommended (e.g. unable to arrange transportation, cognitive and/or behavioral challenges that preclude meaningful participation, poor health, etc.)

Primary outcomes:
measure: Number of Urinary Tract Infections (UTI) Over Time
timeFrame: 6 months prior to treatment and 6 months during treatment
Secondary outcomes:
measure: Change in Score of Neurogenic Bladder Symptom Severity (NBSS) Scale
timeFrame: Baseline to 6 months
measure: Change in Score of Neurogenic Bowel Dysfunction (NBD)
timeFrame: Baseline to 6 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
Study officials:
affiliation: University of Michigan
name: Denise G Tate, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Anne Pelletier-Cameron, MD
role: PRINCIPAL_INVESTIGATOR
References: