Empowerment Program to Reduce Treatment of Asymptomatic Bacteriuria in Veterans With Spinal Cord Injury

NCT07430904 | Not Yet Recruiting

• 2 other identifiers: RRD9-004-25M1IK2RD002113-01A2
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Antimicrobial resistance is a major public health concern that worsens healthcare outcomes. Antibiotic resistant organisms occur more often in Veterans with spinal cord injury or disease (SCI/D) given their frequent exposure to antibiotics, recurrent hospitalizations, and common use of urinary catheter devices. Veterans with SCI/D are also at risk for overtreatment with antibiotics when they do not need them, particularly for over-diagnosed urinary tract infections. The investigators plan to create a patient empowerment program with input of Veterans with SCI/D \[and their providers\] to help guide their decisions and next steps when they have a change in bladder symptoms. The program will give Veterans with SCI/D the tools to speak up to their provider and advocate for themselves to avoid receiving unnecessary antibiotics. This program is highly innovative, as it puts Veterans with SCI/D in charge of thoughtful antibiotic use, or antibiotic stewardship.

Conditions

Spinal Cord Injury; Spinal Cord Disease

Keywords

Asymptomatic Bacteriuria; Antimicrobial Stewardship; Veteran Healthcare; Spinal Cord Injury; Spinal Cord Disease; Neurogenic Bladder

Outcome Measures

Primary Outcomes (1)

• The Incontinence Quality of Life Questionnaire

  Scoring: 28-item survey on a 4-point Likert scale with higher number being associated with better quality of life

  12 months

Secondary Outcomes (14)

• Neurogenic Bladder Symptom Score

  12 months

• The Spinal Cord Injury - Quality of Life (SCI-QOL) survey

  12 months

• Chew's Health Literacy Survey

  6 months

• Knowledge and Attitudes about Antibiotics

  12 months

• Weiner tool Feasibility and acceptability subscales for the empowerment program

  12 months

Study Arms (1)

Pilot Program Participant

EXPERIMENTAL

Veterans with SCI/D and neurogenic bladder

Behavioral: Empowerment Program

Interventions

Empowerment Program BEHAVIORAL

Enrolled participants will receive the program via email and/or mail. In addition, participants will be contacted by a member of the research team to conduct empowerment training. This training will entail walking the participant through the training manual and each of the program's materials. Training will also include an access plan for Veterans to employ when they have genitourinary symptoms and education on how to use the bladder symptom-assessment decision-support aid (the MedStar Urinary Symptom Questionnaire bladder symptom-assessment tool). The access plan will suggest that the Veteran review the empowerment program when they have concerning genitourinary symptoms and decide how they will contact their provider or health care nurse. In addition, a time will be set up for participants to engage in role-playing with a member of the research team to trial the use of the empowerment tool as it should be used in a clinical setting.

Pilot Program Participant

Eligibility Criteria

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

You may qualify if:

• Veterans with SCI/D and neurogenic bladders who have been treated for at least one UTI in the past year
• Have access to a telephone
• Have not been involved in the development phase of the program

You may not qualify if:

• Non-Veterans
• Veterans without SCI/D or neurogenic bladder
• Patients with dementia who would not be able to provide consent or respond to interview prompts
• Patients who do not receive primary care at the MEDVAMC
• Veterans who participated in the development of the empowerment program

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, 77030-4211, United States

Location

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Neurologic Manifestations; 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

Study Officials

• Eva Amenta, MD

  Michael E. DeBakey VA Medical Center, Houston, TX

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eva Amenta, MD

CONTACT

(713) 440-4400; eva.amenta@va.gov

Barbara W Trautner, MD PhD

CONTACT

(713) 440-4438; barbara.trautner@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Patients meeting our study criteria will be recruited for the pilot from the MEDVAMC SCI/D clinics. These criteria include Veterans with SCI/D and neurogenic bladders, who have been treated for at least one UTI in the past year, have access to a telephone, and have not been involved in the development phase of the program (Aims 1 and 2).

Study Record Dates

• First Submitted: February 17, 2026
• First Posted: February 24, 2026
• Study Start (Estimated): August 3, 2026
• Primary Completion (Estimated): December 1, 2031
• Study Completion (Estimated): June 30, 2032
• Last Updated: July 22, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)