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Low Energy Surface Waves for Neurogenic Bladder
N/A
Waitlist Available
Research Sponsored by Lawson Health Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Spinal cord injury (>1 year), multiple sclerosis (>1 year), spina bifida, parkinsons (>1 year)
Indwelling catheter (urethral or suprapubic) for >3 months, and used as primary bladder management mechanism
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights
Study Summary
This trial will test whether the UroShield device, which sends out low-frequency ultrasound waves, can reduce bacteriuria and catheter biofilm formation among neurogenic bladder patients with an indwelling catheter.
Who is the study for?
This trial is for adults over 18 with neurogenic bladder due to conditions like spinal cord injury, multiple sclerosis, or Parkinson's. They must have used an indwelling catheter for over 3 months and had at least one UTI in the past year. People who don't understand English, already use Uroshield, had recent botox treatments in the bladder, take ongoing antibiotics or have a current UTI can't join.Check my eligibility
What is being tested?
The study tests if the Uroshield device can reduce urinary infections and improve life quality for patients with neurogenic bladders using catheters. It compares Uroshield's low-frequency ultrasound waves against a sham (fake) device to see if it prevents bacteria and biofilm on catheters.See study design
What are the potential side effects?
Since this trial involves a non-invasive device that emits ultrasound waves through the catheter, side effects might be minimal but could include discomfort where the actuator attaches or skin irritation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You have had spinal cord injury, multiple sclerosis, spina bifida, or Parkinson's disease for more than 1 year.
Select...
You have had a catheter in your bladder for more than 3 months.
Select...
You have had more than one urinary tract infection in the last year.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Bacteriuria
Secondary outcome measures
Microbiome comparison of biofilms
Neurogenic bladder symptom score (NBSS)
Patient subjective rating of amount of sediment/debris at the end of the 30 days
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active UroshieldExperimental Treatment1 Intervention
Active uroshield device
Group II: ShamPlacebo Group1 Intervention
Inactive uroshield device
Find a Location
Who is running the clinical trial?
Lawson Health Research InstituteLead Sponsor
654 Previous Clinical Trials
413,209 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had more than one urinary tract infection in the last year.You have used the Uroshield device before or are currently using it.You have a urinary tract infection with noticeable symptoms on the day of joining the study.You have had spinal cord injury, multiple sclerosis, spina bifida, or Parkinson's disease for more than 1 year.You have had a catheter in your bladder for more than 3 months.You have received botox treatment inside your bladder in the past 6 months.You are taking antibiotics regularly to prevent an infection.
Research Study Groups:
This trial has the following groups:- Group 1: Active Uroshield
- Group 2: Sham
Awards:
This trial has 0 awards, including: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.
Is the research team in need of additional participants for their study?
"As of the most recent update on June 7th 2022, clinicaltrials.gov does not show this trial as being active for recruitment. It was first posted January 30th 2019 and there are 818 other trials that are presently looking to enrol candidates."
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