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Electrical Stimulation
Closed-Loop Stimulation for Neurogenic Bladder
N/A
Waitlist Available
Led By Dennis Bourbeau, PhD
Research Sponsored by MetroHealth Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Suprasacral SCI (above L5/S1 level of the spinal cord)
Neurologically stable
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 1 week of signing consent form
Awards & highlights
Study Summary
This trial will test a custom algorithm + wireless bladder pressure sensor for individuals with spinal cord injury to improve bladder control & urinary continence.
Who is the study for?
This trial is for individuals with spinal cord injury above the L5/S1 level, stable neurologically, with a mature skeleton and at least 6 months post-injury. They must have bladder control issues confirmed by study. It's not for those with active infections, open sores near the pelvis, urethral damage or history of severe reactions to increased blood pressure.Check my eligibility
What is being tested?
The trial tests a new system that uses noninvasive electrical stimulation of genital nerves to help control the bladder in people who lost this ability due to spinal cord injury. It involves an algorithm and a wireless sensor called UroMonitor that work together automatically.See study design
What are the potential side effects?
Potential side effects may include discomfort or skin irritation where electrodes are placed for nerve stimulation. There might also be unknown risks associated with using the new UroMonitor sensor.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My spinal cord injury is above the L5/S1 level.
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My neurological condition is stable.
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It has been over 6 months since my injury.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 1 week of signing consent form
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 1 week of signing consent form
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
successful reduction of neurogenic bladder spasms
Secondary outcome measures
Comparison of bladder activity with and without genital nerve stimulation
Documentation of NDO with cystometrogram (urodynamics)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Testing closed-loop system in an ambulatory settingExperimental Treatment1 Intervention
Closed-loop system feasibility testing
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Who is running the clinical trial?
MetroHealth Medical CenterLead Sponsor
115 Previous Clinical Trials
21,627 Total Patients Enrolled
The Craig H. Neilsen FoundationOTHER
55 Previous Clinical Trials
2,923 Total Patients Enrolled
Dennis Bourbeau, PhDPrincipal InvestigatorMetroHealth Rehabilitation Institute of Ohio
3 Previous Clinical Trials
22 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My spinal cord injury is above the L5/S1 level.I am currently suffering from a severe infection.My neurological condition is stable.My bones have stopped growing.It has been over 6 months since my injury.You have a history of autonomic dysreflexia.I have open sores near my pelvis where electrodes might be placed.I have severe damage or narrowing of my urethra.You have been diagnosed with neurogenic detrusor overactivity through a special bladder test.
Research Study Groups:
This trial has the following groups:- Group 1: Testing closed-loop system in an ambulatory setting
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the aggregate participation rate for this experimental research?
"Indeed, the information on clinicaltrials.gov reveals that this particular study is currently enrolling participants. This trial was first posted on March 1st 2021 and has just been updated as of February 13th 2023. A total of 12 patients are needed to be recruited from a single medical centre."
Answered by AI
Is there still scope to join this experiment for volunteers?
"According to the research found on clinicaltrials.gov, this trial is presently recruiting participants. It was originally posted on March 1st 2021 and underwent its latest modification on February 13th 2023."
Answered by AI
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