Gentamicin Bladder Instillations to Prevent Urinary Tract Infections in Patients With Spinal Cord Injury

NCT03503513 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: HUM0013708690IFRE0002
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Tract Infections; Spinal Cord Injuries; Spinal Cord Diseases; Neurogenic Bladder

Outcome Measures

Primary Outcomes (1)

• Number of Urinary Tract Infections (UTI) Over Time

  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.

  6 months prior to treatment and 6 months during treatment

Secondary Outcomes (2)

• Change in Score of Neurogenic Bladder Symptom Severity (NBSS) Scale

  Baseline to 6 months

• Change in Score of Neurogenic Bowel Dysfunction (NBD)

  Baseline to 6 months

Study Arms (1)

Gentamicin sulfate

EXPERIMENTAL

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

Interventions

Gentamicin Sulfate DRUG

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.

Also known as: Gent Instillations

Gentamicin sulfate

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• University of Michigan: lead
• Department of Health and Human Services: collaborator

Study Sites (1)

University of Michigan Health System

Ann Arbor, Michigan, 48103, United States

Location

MeSH Terms

Conditions

Urinary Tract Infections; Spinal Cord Injuries; Spinal Cord Diseases; Urinary Bladder, Neurogenic

Interventions

Gentamicins

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Neurologic Manifestations; Urinary Bladder Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aminoglycosides; Glycosides; Carbohydrates

Results Point of Contact

• Title: Dr. Denise Tate
• Organization: University of Michigan

dgtate@umich.edu

(734) 647-5195

Study Officials

• Denise G Tate, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

• Anne Pelletier-Cameron, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Physical Medicine and Rehabilitation

Model Details: 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).

Study Record Dates

• First Submitted: April 6, 2018
• First Posted: April 19, 2018
• Study Start: August 24, 2018
• Primary Completion: September 8, 2023
• Study Completion: September 30, 2023
• Last Updated: June 25, 2024
• Results First Posted: June 25, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)