Study 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.

Condition or Disease	Intervention/Treatment
Urinary Tract Infections Spinal Cord Injuries Spinal Cord Diseases Neurogenic Bladder	Drug: Gentamicin Sulfate

Study Design

Study Type	Interventional
Actual Enrollment	23 participants
Design Allocation	N/A
Interventional Model	Single Group Assignment
Masking	None (Open Label)
Primary Purpose	Prevention
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 Start Date	August 24, 2018
Actual Primary Completion Date	September 8, 2023
Actual Study Completion Date	September 30, 2023

Groups and Cohorts

Group/ Cohort

Intervention/ Treatment

Gentamicin sulfate Participants initiate Gentamicin instillations every night for a treatment period of 6 months. Instillations are stopped if they developed a UTI. After receiving treatment for this UTI, they resume the Gentamicin instillations. After baseline screening and being consented, they are instructed on how to do the instillations through a catheter, once they receive the drug and aid equipment (i.e. syringes) to do installations. Remaining drug from syringes are to be disposed after each use. Participants use their own catheters. In-dwelling catheters are not allowed.

Drug: Gentamicin Sulfate Gentamicin is compounded by the Michigan Medicine Research Pharmacy in a concentration of 480 milligrams of the active product to 1000 milliliters of normal saline. Pharmacy mails participants treatment drug. Once received, participants will do daily instillations of 30 milliliters of solution after catheterizing their bladder at night.

Outcome Measures

Primary Outcome Measures

1. Number of Urinary Tract Infections (UTI) Over Time [6 months prior to treatment and 6 months during treatment]
   Number of reported urinary tract infections (UTI) by participants and documented in medical chart, per person across months pre and post treatment. The number of UTIs over time was determined by establishing a per person-month rate made up of the total number of UTIs pre and during treatment (numerator) for the sample divided by the total number of persons/ 6 months (11 participants over 6 months period = 66) as the denominator. The unit of measure is defined as pre and during treatment number of UTI events per person months. These appear below under outcome measure data table.

Secondary Outcome Measures

1. Change in Score of Neurogenic Bladder Symptom Severity (NBSS) Scale [Baseline to 6 months]
   Self-reported bladder symptoms on a scale from 0 (no symptoms) to 74 (maximum symptoms). The NBSS is a patient reported 22 item scale designed to assess symptoms and bladder related consequences among persons with neurogenic bladder dysfunction. NBSS scores are calculated across three domains with higher scores being worse and reflecting more symptoms or complications. Incontinence (scored 0-29), storage and voiding (scored 0-22), and consequences (scored 0-23). An additional question of happiness (points) was not used for this outcome.
2. Change in Score of Neurogenic Bowel Dysfunction (NBD) [Baseline to 6 months]
   Self-reported bowel symptoms on a scale from 0 (very minor) to 14+ (severe). The NBD is a 10 item validated measure that assesses frequency of defecation and methods of bowel management and complications. Thus negative numbers in "score change" represent decrease in symptom severity.

Eligibility Criteria

Ages Eligible for Study	18 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study	All
Accepts Healthy Volunteers	No
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.)

Contacts and Locations

Sponsors and Collaborators	University of Michigan, Department of Health and Human Services
	Department of Health and Human Services
Locations	University of Michigan Health System | Ann Arbor, Michigan, United States, 48103
Investigators	Principal Investigator: Denise G Tate, PhD, University of Michigan Principal Investigator: Anne Pelletier-Cameron, MD, University of Michigan

Study Documents (Full Text)

• Documents Provided by Denise Tate, PhD: Study Protocol March 9, 2023
• Documents Provided by Denise Tate, PhD: Statistical Analysis Plan June 23, 2023

More Information

Additional Relevant MeSH Terms

• Infections
• Communicable Diseases
• Urinary Tract Infections
• Spinal Cord Injuries
• Urinary Bladder, Neurogenic
• Spinal Cord Diseases
• Wounds and Injuries
• Disease Attributes
• Pathologic Processes
• Central Nervous System Diseases
• Nervous System Diseases
• Trauma, Nervous System
• Urologic Diseases
• Female Urogenital Diseases
• Female Urogenital Diseases and Pregnancy Complications
• Urogenital Diseases
• Male Urogenital Diseases
• Neurologic Manifestations
• Urinary Bladder Diseases