Empowerment Program for Spinal Cord Injury

EA
BW
Overseen ByBarbara W Trautner, MD PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: VA Office of Research and Development
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help Veterans with spinal cord injury or disease manage their antibiotic use more effectively. The goal is to develop an Empowerment Program that enables them to make informed decisions about antibiotics, particularly when they notice changes in bladder symptoms. The program focuses on reducing unnecessary antibiotic treatments, which can lead to resistant infections. Veterans with a neurogenic bladder (bladder problems due to nerve issues) who have experienced at least one urinary tract infection in the past year might be suitable candidates. As an unphased trial, this study offers Veterans the opportunity to actively contribute to developing a program that could enhance their health management.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on empowering you to make informed decisions about antibiotic use, so you may not need to change your current medications.

What prior data suggests that this empowerment program is safe for Veterans with spinal cord injury or disease?

Research has shown that empowerment programs can be safe and beneficial for individuals with spinal cord injuries and bladder issues. The program educates and empowers patients without medications or invasive treatments, minimizing the risk of side effects.

The program aims to help Veterans with spinal cord injuries manage their bladder health more effectively. It teaches effective communication with healthcare providers and helps avoid unnecessary antibiotic treatments. This emphasis on education and self-advocacy generally carries minimal risk.

Because the program does not involve new drugs or surgeries, participants are unlikely to experience related side effects. They can expect a positive experience focused on learning and empowerment, with a low likelihood of negative effects.12345

Why are researchers excited about this trial?

Researchers are excited about the Empowerment Program for spinal cord injury (SCI) because it offers a unique approach to managing the condition, especially for veterans with neurogenic bladder issues. Unlike traditional treatments that primarily focus on medication and physical therapy, this program emphasizes psychological and social support to enhance quality of life. By empowering individuals with SCI, the program aims to foster self-management skills and improve mental well-being, which are often overlooked in standard care. This holistic approach could potentially lead to better overall outcomes for participants, making it a promising avenue for future care strategies.

What evidence suggests that this empowerment program is effective for spinal cord injury?

Research has shown that programs encouraging individuals to believe in their ability to manage their health can assist those with neurogenic bladder following a spinal cord injury. One study found that participants in such a program managed their bladder better and used fewer antibiotics. This is crucial because excessive antibiotic use can make infections harder to treat. By helping individuals manage their symptoms and communicate with their doctors, these programs might lower the risk of complications and reduce the need for antibiotics. The Empowerment Program, which participants in this trial will join, could be a promising way to improve health for people with spinal cord injuries.46789

Who Is on the Research Team?

EA

Eva Amenta, MD

Principal Investigator

Michael E. DeBakey VA Medical Center, Houston, TX

Are You a Good Fit for This Trial?

This trial is for Veterans with spinal cord injury or disease and neurogenic bladder who have had at least one urinary tract infection treated in the past year, can use a phone, and get primary care at MEDVAMC. It excludes non-Veterans, those without SCI/D or neurogenic bladder, dementia patients unable to consent, and anyone involved in developing the program.

Inclusion Criteria

Participants must not have been involved in the development phase of the program
Participants must have access to a telephone
I am a veteran with a spinal cord injury and neurogenic bladder, and I had at least one UTI treated in the past year.

Exclusion Criteria

Non-Veterans
Veterans without SCI/D or neurogenic bladder
Patients who do not receive primary care at the MEDVAMC
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pilot Program

Veterans with SCI/D and neurogenic bladder participate in the empowerment program, including role-playing activities and marketing materials

12 months
Monthly visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after the pilot program

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Empowerment Program

Trial Overview

The study tests an empowerment program designed to help Veterans with spinal cord injuries make informed decisions about antibiotic use when they notice changes in their bladder symptoms. The goal is to reduce unnecessary antibiotic treatments by giving participants tools to communicate better with their healthcare providers.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Pilot Program ParticipantExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials
1,691
Recruited
3,759,000+

Citations

Effects of a self‐efficacy‐centered self‐management program ...

Effects of a self‐efficacy‐centered self‐management program on neurogenic bladder after spinal cord injury: A randomized controlled trial.

Bladder Management Following Spinal Cord Injury

Combinatorial treatment with 2 of oxybutynin, tolterodine or trospium may be effective for the treatment of neurogenic detrusor overactivity in individuals with.

Upper and Lower Urinary Tract Surveillance

Individuals with SCI and neurogenic bladder are at greater risk for serious medical problems such as kidney failure, kidney and bladder stones, ...

Rehabilitation care of patients with neurogenic bladder after ...

This article reviews the research progress of rehabilitation treatment and nursing care of patients with neurogenic bladder after spinal cord injury.

The Efficiency of Rehabilitation Therapy in Patients ...

The current study aims to bring up-to-date findings on rehabilitation methods for treating neurogenic bladder.

Empowerment Program for Spinal Cord Injury

I am a veteran with a spinal cord injury and neurogenic bladder, and I had at least one UTI treated in the past year. Exclusion Criteria. Non- ...

Neurogenic Bladder - Spinal Cord Injury Empowerment Project

Your bladder muscles may be overactive and contract when you don't want them to, causing leaking or incontinence. • Sometimes the bladder sphincters (circular ...

Interventional effects of action research combined with ... - PMC

After intervention, EG showed significant improvements in safe bladder capacity and bladder function grading (P < .05). The number of patients ...

Neurogenic Bladder Medications & Treatments Post SCI

A 2024 systematic review published in Spinal Cord examined SCI-specific outcomes with Botox, confirming the benefit observed in the original ...