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Neuromodulation
SCONE Therapy for Neurogenic Bladder (CONTINENCE Trial)
N/A
Recruiting
Research Sponsored by SpineX Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject has symptoms of urinary urgency (>50% high urge voids) or increased frequency of micturition/self-catheterization (more than once every 2 hours) or incontinence between voids or catheterizations (>5/day).
Subject has a diagnosis of NLUTD due to: Chronic, spinal cord injury at C3 to T8 classified as ASIA A-B on the AIS scale OR Chronic, spinal cord injury at C3 to L1 classified as ASIA C-D on the AIS scale OR Multiple sclerosis; OR Stroke
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
CONTINENCE Trial Summary
This trial will compare SCONE therapy to an inactive control to see if it can improve symptoms of NLUTD.
Who is the study for?
This trial is for adults aged 18-70 (75 for females) with stable medical conditions and a support network. They must have neurogenic lower urinary tract dysfunction due to spinal cord injury, multiple sclerosis, or stroke, and be at least one year post-diagnosis. Participants need symptoms like urgency or frequent urination/incontinence and no significant autonomic dysreflexia, severe heart/kidney/liver disease, other CNS diseases besides the qualifying ones, morphologic bladder obstruction history, or reliance on indwelling catheters.Check my eligibility
What is being tested?
The SCONE 'CONTINENCE' study tests if SCONE neuromodulation therapy can improve symptoms of Neurogenic Lower Urinary Tract Dysfunction after 12 weeks compared to a sham control. It's designed to see how effective and safe this treatment is in managing issues like urinary urgency and incontinence.See study design
What are the potential side effects?
While specific side effects are not listed here, participants should consider potential risks associated with neuromodulation therapies such as discomfort at the stimulation site, infection risk from implanted devices if any are used, possible interference with bodily functions controlled by nerves involved in the treatment area.
CONTINENCE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I often feel a strong need to urinate or need to use the bathroom more than once every 2 hours.
Select...
I have bladder dysfunction due to a spinal cord injury or a condition like MS or stroke.
Select...
I often feel a strong need to urinate or need to use the bathroom more than once every 2 hours.
Select...
I have bladder dysfunction due to a spinal injury, multiple sclerosis, or stroke.
Select...
I am a man between 18 and 70 years old or a woman between 18 and 75 years old.
Select...
I have a spinal cord injury between C3-T8, multiple sclerosis, or have had a stroke.
Select...
My bladder muscle involuntarily contracts strongly.
Select...
I am between 18 and 70 years old.
CONTINENCE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Neurogenic Bladder Symptom Score (NBSS)
Secondary outcome measures
Patient Global Improvement Index (PGI-I)
Urge Urinary Incontinence Episodes
CONTINENCE Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Therapeutic ArmExperimental Treatment1 Intervention
Group II: Sham ArmPlacebo Group1 Intervention
Find a Location
Who is running the clinical trial?
University of Miami, Miami, United StatesUNKNOWN
Spaulding Rehabilitation Hospital, Charlestown, Massachusetts, United StatesUNKNOWN
Craig Hospital, Englewood, Colorado, United StatesUNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your score on the NBSS survey is higher than 28.I understand the study, agree to participate, and have signed the consent form.I have had a bladder botox injection in the last year.I often feel a strong need to urinate or need to use the bathroom more than once every 2 hours.You need a tube to drain urine from your bladder.I have serious heart, lung, kidney, liver problems, or my diabetes is not well-controlled.I have had surgery on my bladder or have a urinary stoma.Your body mass index (BMI) is higher than 35.I have had 5 or more UTI treatments in the last year.I have bladder dysfunction due to a spinal cord injury or a condition like MS or stroke.I often feel a strong need to urinate or need to use the bathroom more than once every 2 hours.If you can pee without using a tube, the amount of urine left in your bladder after you pee is more than 100 mL when measured by a special machine or a one-time tube used to empty the bladder.I was diagnosed with a neurogenic lower urinary tract disorder over a year ago.I have bladder dysfunction due to a spinal injury, multiple sclerosis, or stroke.I have health issues that could interfere with the study, as decided by the study doctor.I have had blockages in my bladder outlet due to conditions like an enlarged prostate.I experience significant urine leakage during activities like coughing or sneezing more than 3 times a day.My health condition is currently stable.I have a brain or nerve condition that is not a spinal cord injury, MS, or stroke.I am a man between 18 and 70 years old or a woman between 18 and 75 years old.I experience severe headaches and high blood pressure over 180 mmHg more than once a week.You do not have any bacteria in your urine, or if you do, it's not causing any symptoms.I am a man over 55 with symptoms of an enlarged prostate.I have or might have pelvic organ prolapse.I have a spinal cord injury between C3-T8, multiple sclerosis, or have had a stroke.My bladder muscle involuntarily contracts strongly.I am between 18 and 70 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Therapeutic Arm
- Group 2: Sham Arm
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.
How many people have enrolled in this clinical trial thus far?
"In order for this trial to be conducted successfully, 130 participants that qualify must be identified. SpineX Inc., the lead sponsor of the study, will host it in multiple sites including Univ of California, San Diego and Craig Hospital."
Answered by AI
Are there any current opportunities for participants to enroll in this trial?
"Data hosted on clinicaltrials.gov confirms that recruitment for this medical trial is ongoing, with the initial post made on May 25th 2022 and latest update occurring on June 8th of the same year."
Answered by AI
For what types of individuals is this trial most appropriate?
"In order to qualify for this clinical experiment, applicants must be between 18 and 70 years old and diagnosed with multiple sclerosis. The study is looking for a total of 130 volunteers."
Answered by AI
How many locations are administering this research project?
"The 4 sites participating in the trial are located in San Diego, Denver and Downey as well as a few other cities. To lessen any travel burden, it is advised to find the location nearest you if you choose to join this study."
Answered by AI
Does this research include participation from those aged 25 and above?
"The requirements for entry into this medical trial stipulate a minimum age of 18 and a maximum age of 70."
Answered by AI
Who else is applying?
What state do they live in?
Mississippi
Nevada
How old are they?
18 - 65
What site did they apply to?
Rancho Research Institute
Craig Hospital
Atrium Health
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Why did patients apply to this trial?
I had an incomplete spinal cord injury 9/18/23. At first I was able to self catheterize. Then my urethra constricted. I now have a supra pubic. I would like to restore normal bladder function.
Do you need information from my urologist or neuro surgeon, since it was a spinal cord injury? For treatment I can drive to Charlotte. I live about 10 miles from Atrium Wake Forest. My treating neurosurgeon was an Atrium physician.
PatientReceived 1 prior treatment
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