Gentamicin Bladder Instillation in Individuals With Spinal Cord Injury Having Chronic Urinary Tract Infections

NCT03931408 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 18.0586
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

Participants will undergo daily gentamicin bladder instillations to determine if its use will reduce the rate of symptomatic urinary tract infections (UTIs) as well as the use of oral and intravenous antibiotics in adults with chronic spinal cord injury (SCI) who have recurrent UTIs. Participants are randomized into one of three groups: 1) Gentamicin and saline instillation 2) Saline only instillation 3) Standard of care, no instillation.

Conditions

Neurogenic Bladder; Spinal Cord Injuries

Keywords

bladder; spinal cord injury; urinary tract infection

Outcome Measures

Primary Outcomes (1)

• Evaluate Bladder Storage Using Urodynamics

  Assessment of Lower Urinary Tract Function: Urodynamic Bladder Compliance (mL/cm H20) based on Change in Bladder Capacity.

  1. Baseline (1 week) 2. Midpoint (2 months) 3. Post (4 months)

Secondary Outcomes (1)

• Participants With Symptomatic Urinary Tract Infection

  1. Baseline (1 week) 2. Midpoint (2 months) 3. Post (4 months)

Study Arms (3)

Gentamicin

EXPERIMENTAL

Participants will be randomized into one of three groups. In this arm, participants will perform bladder instillations using a 50ml solution of gentamicin mixed with saline, 2 times per day. A formulation derived from 480 mg gentamicin sulfate diluted in 1 L normal saline will be used for instillation. Participants will be blinded during the study and will not know if they are receiving gentamicin or placebo (saline alone).

Drug: Gentamicin Sulfate

Placebo instillation (saline alone)

PLACEBO COMPARATOR

Participants will be randomized into one of three groups. In this arm, participants will perform bladder instillations using a 50ml solution of saline alone. Participants will be blinded during the study and will not know if they are receiving gentamicin or placebo (saline alone).

Other: Placebo instillation (saline alone)

No instillation

OTHER

Participants will be randomized into one of three groups. In this arm participants will not receive an instillation of gentamicin or saline alone, but instead will continue standard of care. Participants will be assessed at the pre-, mid- and post-intervention time points.

Other: No instillation

Interventions

Gentamicin Sulfate DRUG

Gentamicin will be compounded for immediate use in single-dose, disposable BD 50ml Luer-Lok tip syringes. The container closure system for the diluted gentamicin sulfate solution and saline solution will be sterile and processed with depyrogenation. The solution will be slowly infused into the bladder after drainage of urine is complete. While monitoring blood pressure, the solution will remain in the participant's bladder for a least 30 minutes (unless the participant is experiencing autonomic dysreflexia, and in that case, immediately drained) with the goal of attaining 2 hours.

Also known as: Gentamicin only

Gentamicin

Placebo instillation (saline alone) OTHER

Saline will be compounded for immediate use in single-dose, disposable BD 50ml Luer-Lok tip syringes. The container closure system for the diluted gentamicin sulfate solution and saline solution will be sterile and processed with depyrogenation. The solution will be slowly infused into the bladder after drainage of urine is complete. While monitoring blood pressure, the solution will remain in the participant's bladder for a least 30 minutes (unless the participant is experiencing autonomic dysreflexia, and in that case, immediately drained) with the goal of attaining 2 hours.

Also known as: Saline only

Placebo instillation (saline alone)

No instillation OTHER

Participants will not receive an instillation of gentamicin or saline alone, but instead will continue standard of care. Participants will be assessed at the pre-, mid- and post-intervention time points.

No instillation

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Louisville: lead

Study Sites (1)

Frazier Rehab

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

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

Interventions

Gentamicins; Sodium Chloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Aminoglycosides; Glycosides; Carbohydrates; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Dr. Harkema
• Organization: University of Louisville

lori.clark2@louisville.edu

502-582-7676

Study Officials

• Susan Harkema, PhD

  University of Louisville

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Before the intervention, you will be randomly assigned to one of three groups.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2019
• First Posted: April 30, 2019
• Study Start: February 19, 2019
• Primary Completion: July 14, 2020
• Study Completion: December 30, 2020
• Last Updated: January 29, 2025
• Results First Posted: January 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)