Multiple Sclerosis Clinical Trial

Spinal COrd NeuromodulaTor by SpIneX and ScoNE to Treat NeurogeniC BladdEr – SCONE “CONTINENCE” Clinical Study

Summary

The purpose of this study is to evaluate the effectiveness and safety of SCONE neuromodulation therapy after 12 weeks of therapy in comparison to inactive sham control in improving symptoms of Neurogenic Lower Urinary Tract Dysfunction

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Subject is ≥ 18 and ≤ 70 years old (male subjects) or ≥ 18 and ≤ 75 years (female subjects) at the time of enrollment/consent.

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
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 sterile urine or asymptomatic bacteriuria.
Subject's score is > 28 on NBSS survey.
Subject is at least one year post initial diagnosis of NLUTD at the time of enrollment (consent).
Subject's medical condition is stable.
Subject has adequate social support network to be able to participate in training and assessment sessions for the duration of the study, at the discretion of the Investigator.
Subject has been informed of the nature of the study, can understand the requirements of the study, agrees to participate, and has signed the IRB/REB/EC-approved informed consent.

Exclusion Criteria:

Subject relies on an indwelling catheter (urethral or suprapubic) for bladder drainage.
Subject has a history of bladder augmentation or continent or incontinent urinary stoma or prior bladder surgery.
Subject has congestive heart failure, pulmonary disease necessitating supplemental oxygen use, chronic kidney disease (Stage III or higher), chronic liver disease (Child Pugh class B or C) or poorly controlled diabetes (if diabetic, HbA1c > 8.0 within the preceding 6 months).
Subject has a concurrent neurological disease affecting the central nervous system, other than spinal cord injury or multiple sclerosis or stroke.
Subject has an implanted central or peripheral neuromodulator.
Subject has symptomatic, clinically significant autonomic dysreflexia attacks (characterized by headache and systolic blood pressure greater than 180 mmHg) more than once a week.
Subject is dependent on an electromagnetic medical implant (e.g., cardiac pacemaker or implanted drug pump), ventilation support, or other external device.
Subject has received intravesical botulinum toxin injection within 12 months preceding enrollment.
Subject's BMI is > 35.
Subject has history of morphologic bladder outlet obstruction (e.g., due to benign prostatic hyperplasia, urethral stricture and /or bladder neck contracture).
Subject has history of frequent symptomatic urinary tract infections, defined as receiving five or more courses of urinary tract infection directed antibiotics within 12 months prior to enrollment.
For non catheterizing subjects, post void residual is > 100 mL measured by bladder ultrasound, bladder scanner, or one time catheterization at the time of enrollment
For female subjects, history and/or screening responses consistent with pelvic organ prolapse.
For non catheterizing male subjects older than 55 years of age, screening responses consistent with benign prostatic hyperplasia.
Subjects with significant stress incontinence (> 3 stress incontinence episodes per day), defined as incontinence episodes during physical activity such as cough, sneeze, transfers, and other forms of physical activity.
Subject is pregnant or trying to become pregnant; or is nursing.
Subject has limited life expectancy or comorbid conditions, social/psychological problems, or cognitive impairments that, in the opinion of the Investigator, will preclude them from participation and completion of study procedures or requirements.
Subject has a medical condition or complications related to the use of certain medications that may affect validity of the study as determined by the Investigator.
Subject has a medical condition not listed above that may put the subject at risk as determined by the Investigator.
Subject is participating in or plans to participate in another research study that may interfere with study endpoints.
Subject is known or suspected to be non compliant; and/or subject is unable or unwilling to comply with study requirements.
Subject was enrolled after the maximum number of targeted subjects were randomized into the respective disease or UUI group.

Study is for people with:

Multiple Sclerosis

Estimated Enrollment:

130

Study ID:

NCT05301335

Recruitment Status:

Recruiting

Sponsor:

SpineX Inc.

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There are 11 Locations for this study

See Locations Near You

Rancho Research Institute
Downey California, 90242, United States More Info
Spencer Toledo
Contact
[email protected]
UC San Diego Health Systems
San Diego California, 92093, United States More Info
Trisha Kanie
Contact
[email protected]
Craig Hospital
Denver Colorado, 80113, United States More Info
Clare Morey
Contact
[email protected]
Medstar National Rehab
Washington District of Columbia, 20010, United States More Info
Christopher Riegner
Contact
[email protected]
Suzanne Groah, MD
Principal Investigator
University of Miami, Desai Sehti Urology Institute
Miami Florida, 33136, United States More Info
Zoe Szczotka
Contact
[email protected]
Shepherd Centre
Atlanta Georgia, 30309, United States More Info
Cathy Furbish
Contact
[email protected]
Spaulding Rehabilitation Hospital Cambridge
Cambridge Massachusetts, 02138, United States More Info
William Muter
Contact
[email protected]
Mayo Clinic, St. Mary's Campus
Rochester Minnesota, 55902, United States More Info
Tyson Scrabeck
Contact
[email protected]
Columbia University Irving Medical Centre
New York New York, 10032, United States More Info
Mahveesh Chowdhurry
Contact
[email protected]
Atrium Health
Charlotte North Carolina, 28208, United States More Info
Robbin Clark
Contact
[email protected]
ICORD Vancouver
Vancouver British Colombia, V5Z 1, Canada More Info
Jennifer Phan
Contact
[email protected]
Insitute of Brain and Spine
New Delhi , , India More Info
Sachin Samuel
Contact
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Estimated Enrollment:

130

Study ID:

NCT05301335

Recruitment Status:

Recruiting

Sponsor:


SpineX Inc.

How clear is this clinincal trial information?

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