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Neuromodulation Device

PrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN) for Spinal Cord Injury

N/A
Waitlist Available
Led By Jeremy B Myers, MD
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3, 6, 9, 12 months
Awards & highlights

Study Summary

This trial will study the effects of sacral neuromodulation on bladder function & quality of life in patients w/ acute spinal cord injury.

Eligible Conditions
  • Spinal Cord Injury
  • Urinary Tract Infection
  • Neurogenic Bladder
  • Urinary Incontinence

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3, 6, 9, 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3, 6, 9, 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of urinary tract infections per year
Quality of Life differences measured by mean SCI-QoL
Urodynamic determined maximum cystometric capacity
Secondary outcome measures
24 hour pad weight test
Average catheterization volume
Death
+14 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Sacral neuromodulationExperimental Treatment1 Intervention
Bilateral sacral neuromodulation will start within 3 months of spinal cord injury, as well as standard neurogenic bladder care.
Group II: Standard careActive Control1 Intervention
Patients will receive standard neurogenic bladder care.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN)
2019
N/A
~50

Find a Location

Who is running the clinical trial?

University of MichiganOTHER
1,800 Previous Clinical Trials
6,379,092 Total Patients Enrolled
Rancho Research Institute, Inc.OTHER
7 Previous Clinical Trials
465 Total Patients Enrolled
University of UtahLead Sponsor
1,102 Previous Clinical Trials
1,779,213 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do I meet the requirements to participate in this experiment?

"Qualified candidates for this clinical trial must have been diagnosed with a urinary tract infection and be between 18 to 100 years old. Approximately 48 individuals are required to participate in the study."

Answered by AI

What is the current capacity of this research project in terms of participants?

"To adequately participate in this trial, 48 suitable candidates are needed. These potential participants can be found at University of Michigan in Ann Arbor and Carolinas Rehabilitation in Charlotte, North carolina."

Answered by AI

How many facilities are administrating this trial?

"For this clinical trial, patients may be recruited from University of Michigan in Ann Arbor, Michigan and Carolinas Rehabilitation in Charlotte North carolina, among others. One noteworthy site is Rancho Los Amigos National Rehabilitation Center located in Downey California."

Answered by AI

Is the age restriction for volunteers in this study set at 18 or above?

"The parameters for this clinical trial stipulate that applicants range in age from 18 to 100. For those outside of the accepted age range, there are 171 studies available for adolescents and 803 separate trials for seniors."

Answered by AI

Are there any open enrollment opportunities for this research endeavor?

"Affirmative, the information on clinicaltrials.gov affirms that this trial is currently recruiting participants. The listing was initially posted on August 7th 2019 and recently revised on November 3rd 2021. They need 48 volunteers distributed across 5 locations to participate in the study."

Answered by AI

Who else is applying?

What state do they live in?
Ohio
California
Texas
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What site did they apply to?
University of Michigan
Rancho Los Amigos National Rehabilitation Center

How responsive is this trial?

Average response time
  • < 2 Days
Most responsive sites:
  1. Rancho Los Amigos National Rehabilitation Center: < 48 hours
Typically responds via
Phone Call
Recent research and studies
BMC UrologyJournal
Protocol for a Randomized Clinical Trial Investigating Early Sacral Nerve Stimulation as an Adjunct to Standard Neurogenic Bladder Management Following Acute Spinal Cord Injury
Redshaw, Jeffrey D., for the Neurogenic Bladder Research Group (NBRG.org), Sara M. Lenherr, Sean P. Elliott, John T. Stoffel, Jeffrey P. Rosenbluth, Angela P. Presson, and Jeremy B. Myers. 2018. “Protocol for a Randomized Clinical Trial Investigating Early Sacral Nerve Stimulation as an Adjunct to Standard Neurogenic Bladder Management Following Acute Spinal Cord Injury”. BMC Urology. Springer Science and Business Media LLC. doi:10.1186/s12894-018-0383-y.
clinicaltrials.govStudy
Sacral Nerve Stimulation in Improving Bladder Function After Acute Traumatic Spinal Cord Injury
Jeremy Myers 2019. "Sacral Nerve Stimulation in Improving Bladder Function After Acute Traumatic Spinal Cord Injury". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03083366.
~8 spots leftby May 2025
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