Neurorecovery and Rehabilitation Research Center

Research Project 1 - Wound study

Pressure Injury study to test Effectiveness of a Powder Dressing to Standard of Care Treatment in Stage 2,3, and 4

This study seeks to compare the effectiveness of Altrazeal (Transforming Powder Dressing) in reducing primary dressing changes in the treatment of non-infected Stage 2, 3, and 4 pressure injuries over a 12-week period versus standard of care therapies recommended within the 2019 NPIAP Guidelines.

Participants must be:

• 18 to 85 years of age
• Stage 2, 3 or 4 pressure ulcers
• Wound exudate is mild to moderate
• No active wound infection (clinical diagnosis)
• Able and willing to provide written (not proxy) informed consent
• Clinically stable, as determined by: Medical history, Vital signs, Physical exam, Laboratory testing prior to enrollment

Participants will be in this study for 12 weeks and will have to be seen in person once a week for the duration of the study.

For more information, please visit https://clinicaltrials.gov/study/NCT05496296

If you are interested or have questions, please contact:

Ana Valeria Aguirre Guemez, MD
anavaleria.aguirreguemez@medstar.net
202-877-1875

Research Project 2 - Autonomic dysfunction

Testing a New Device to Track Autonomic Symptoms After Spinal Cord Injury

To use an investigational device (similar to a wristwatch) to measure wrist temperature. The goal is to determine if the device can help predict autonomic dysreflexia.

Participants must:

• Be 18+ years old
• Be admitted to MedStar NRH for inpatient rehabilitation
• Have an SCI at level L3 or above
• Be free of pre existing heart conditions

Participants will be enrolled in the study for the duration of their rehabilitation stay, during which the device will be worn constantly and will continuously sample wrist temperature. Participants will also complete an autonomic function exam at enrollment and at discharge.

If you are interested or have questions, please contact:

Chris Riegner, MPH
christopher.r.riegner@medstar.net
202-892-5857

Project 3 – Bladder instillation study

Gentamicin + Lactobacillus Bladder Flushes for Urinary Symptoms in Intermittent Catheter Users

We are recruiting participants in DC, MD, PA, and VA for a bladder study looking at the use of a combined antibiotic/probiotic bladder flush when experiencing urinary symptoms.

Participants must:

• Be diagnosed with neurogenic bladder (SCI, MS, SB, stroke, etc.)
• Use intermittent catheterization for bladder management
• 18 years or older
• No urinary symptoms at time of enrollment

Objective 1: Participants nationwide will be randomized into a low or high dose bladder wash group to determine whether high or low dose Lactobacillus GG is more effective at re-colonizing the bladder following intravesical gentamicin use for urinary symptoms.

Objective 2: Participants will collect and mail urine samples before, during, and after the combination gentamicin-Lactobacillus washes to determine the effect on the urine.

For more information, please visit https://clinicaltrials.gov/study/NCT07643974

If you are interested or have questions, please contact:

Chris Riegner, MPH
christopher.r.riegner@medstar.net
202-892-5857

Research Project 4 – UTI diagnosis and treatment study

Assessing a Faster Way to Diagnose and Treat Urinary Tract Infections in People Who Use Catheters

A rapid diagnostic tool for urinary tract infection in spinal cord injury and neurogenic lower urinary tract dysfunction using a catheter[IL2.1] We are recruiting participants in the Washington DC metropolitan area for a bladder study. The study will examine how a rapid diagnostic tool (Jiddu) may help improve treatment decisions for urinary tract infections (UTIs).

Participants must:

• Be 18 years or older
• Diagnosed with neurogenic bladder due to SCI
• Using indwelling catheter for bladder management (urethral or suprapubic catheterization
• Presenting for suspected UTI

For more information, please visit https://clinicaltrials.gov/study/NCT07784829

If you are interested or have questions, please contact:

Madison Hughes, MS
madison.r.hughes@medstar.net
845-260-1577

Research Project 5– Urine collection study

Validating the Jiddu Analyzer for Urine Bacterial Growth in Neurogenic Lower Urinary Tract Dysfunction

Short Title: A New Device to Detect Bacteria in Urine in People With Neurogenic Bladder

We are recruiting participants in the Washington DC metropolitan area for a bladder study. The study will examine urine samples up to 5 timepoints from each participant. The specific aim for this study is to establish a reproducible analysis protocol.

Participants must:

• Be 18 years or older
• Diagnosed with neurogenic bladder (SCI, MS, SB, stroke, etc.)

If you are interested or have questions, please contact:

Ana Valeria Aguirre Guemez, MD
anavaleria.aguirreguemez@Medstar.net
202-877-1875

Research Project 6 – Bladder instillation interview

Patient and Caregiver Perspectives on Intravesical Instillations for Urinary Symptoms

The purpose of this study is to determine perspectives of patients and caregivers on various types of intravesical instillations for urinary health. The aim is to identify perceived benefits, barriers, and opportunities related to Lactobacillus and/or gentamicin instillations.

Participants must:

• Be 18 years or older
• Diagnosed with neurogenic bladder (SCI, MS, SB, stroke, etc.)
• Using intermittent catheterization for bladder management
• Have experience of using Lactobacillus and/or Gentamicin bladder instillations

OR

• Caregivers with experience facilitating any type of bladder instillations

If you are interested or have questions, please contact:

Chris Riegner, MPH
christopher.r.riegner@medstar.net
202-892-5857

Research Project 7 – Bladder instillation study ENROLLMENT ENDED

Comparison of Lactobacillus + Saline Bladder Wash vs. Saline Only Bladder Wash for Urinary Symptoms in Intermittent Catheter Users

The objective of this study is to compare a probiotic + saline bladder wash vs. standard care saline only bladder wash in reducing urinary symptoms.

Participants must:

Be 18 years or older

• Diagnosed with spinal cord injury
• Use intermittent catheter
• History of urinary symptoms or urinary tract infections

For more information, please visit https://clinicaltrials.gov/study/NCT05230511

Upcoming projects

Research Project – Respiratory study

Abdominal Stimulation to Improve Cough After Spinal Cord Injury (COUFUS study)

This study is a randomized, sham controlled, double-blinded multi-center clinical trial to evaluate abdominal FES in adult patients with spinal cord injury to increase the strength of the abdominal wall muscles and improve cough peak flow. Eligible participants will be randomized 1:1 to the VentFree Respiratory Muscle Stimulator or a sham treatment.

Participants must:

• Be 22 years or older
• New non-progressive SCI occurring in the past 3 to 8 weeks.
• A neurological level of injury of C1-T5
• American Spinal Injuries Association Impairment Scale A to C
• Cough peak flow (CPF) of <160 L/min
• Expected to remain in inpatient rehabilitation for at least 3 more weeks

Completed projects

Lactobacillus Bladder Flush for Urinary Symptoms in Indwelling Catheter Users

Objective 1: Participants in the metropolitan Washington, D.C., area will provide two urine samples at least two weeks apart when not experiencing urinary symptoms.

Objective 2: Participants nationwide will be randomized into a low or high dose bladder wash group using an intravesical probiotic called Lactobacillus GG. Instillations will occur when experiencing urinary symptoms.  

For more information, please visit https://clinicaltrials.gov/study/NCT04323735

A Mixed Methods Assessment of the Impact of Transcutaneous Tibial Nerve Stimulation (TTNS) on Quality of Life and Participation

Study Objective: The primary objective of this study is to evaluate the burden of Neurogenic Lower Urinary Tract Dysfunction (NLUTD) on Health-related Quality of Life (QOL), determine what constitutes a clinically meaningful difference in Neurogenic Lower Urinary Tract Dysfunction (NLUTD)-related QOL and participation Identify NLUTD user-defined themes regarding bladder function and the effects of TTNS neuromodulation on the daily impacts on one’s life.

For more information, please visit https://clinicaltrials.gov/study/NCT04248322

Intravesical L. crispatus: Clinical Safety and Microbiome Evaluation in Intermittent Catheter Users

To find out if a probiotic bladder treatment with L. crispatus is safe and easy for people to use. The goal is to see if it can help treat urinary symptoms and without using antibiotics.

For more information, please visit https://clinicaltrials.gov/study/NCT07308808