Clinical trial NCT05301335: Spinal COrd NeuromodulaTor by SpIneX and ScoNE to Treat NeurogeniC BladdEr - SCONE "CONTINENCE" Clinical Study
Official title: Spinal Cord Neuromodulator by SpineX and Scone to Treat Neurogenic Bladder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neurogenic Bladder
Spinal Cord Injuries (Complete and Incomplete)
Stroke
Multiple Sclerosis
Lead sponsor: SpineX Inc.
Sponsor class: INDUSTRY
Collaborators: name: Rancho Los Amigos National Rehabilitation Center, Downey, California, United States
name: Atrium Health, Charlotte, North Carolina, United States
name: MedStar National Rehabilitation Network, Washington, District of Columbia, United States
name: University of California, San Diego, California United States
name: Craig Hospital, Englewood, Colorado, United States
name: Columbia University, New York City, New York, United States
name: Institute of Brain and Spine (IBS Hospital), New Delhi, India
name: International Collaboration On Repair Discoveries (ICORD), Vancouver, British Columbia, Canada
name: University of Miami, Miami, United States
name: Mayo Clinic, Rochester, Minnesota, United States
name: Shepherd Center, Atlanta, Georgia, United States
name: Spaulding Rehabilitation Hospital, Charlestown, Massachusetts, United States
First posted: 2022-03-29
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study is designed as a prospective, multicenter, single blind, two-arm randomized sham-controlled clinical study. Subjects will be randomized into a treatment arm and control (sham) arm in a 2:1 ratio.
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: Inclusion Criteria:

1. Subject is ≥ 18 and ≤ 70 years old (male subjects) or ≥ 18 and ≤ 75 years (female subjects) at the time of enrollment/consent.
2. 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
3. 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).
4. Subject has sterile urine or asymptomatic bacteriuria.
5. Subject's score is \> 28 on NBSS survey.
6. Subject is at least one year post initial diagnosis of NLUTD at the time of enrollment (consent).
7. Subject's medical condition is stable.
8. 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.
9. 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:

1. Subject relies on an indwelling catheter (urethral or suprapubic) for bladder drainage.
2. Subject has a history of bladder augmentation or continent or incontinent urinary stoma or prior bladder surgery.
3. 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).
4. Subject has a concurrent neurological disease affecting the central nervous system, other than spinal cord injury or multiple sclerosis or stroke.
5. Subject has an implanted central or peripheral neuromodulator.
6. Subject has symptomatic, clinically significant autonomic dysreflexia attacks (characterized by headache and systolic blood pressure greater than 180 mmHg) more than once a week.
7. Subject is dependent on an electromagnetic medical implant (e.g., cardiac pacemaker or implanted drug pump), ventilation support, or other external device.
8. Subject has received intravesical botulinum toxin injection within 12 months preceding enrollment.
9. Subject's BMI is \> 35.
10. Subject has history of morphologic bladder outlet obstruction (e.g., due to benign prostatic hyperplasia, urethral stricture and /or bladder neck contracture).
11. 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.
12. 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
13. For female subjects, history and/or screening responses consistent with pelvic organ prolapse.
14. For non catheterizing male subjects older than 55 years of age, screening responses consistent with benign prostatic hyperplasia.
15. 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.
16. Subject is pregnant or trying to become pregnant; or is nursing.
17. 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.
18. 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.
19. Subject has a medical condition not listed above that may put the subject at risk as determined by the Investigator.
20. Subject is participating in or plans to participate in another research study that may interfere with study endpoints.
21. Subject is known or suspected to be non compliant; and/or subject is unable or unwilling to comply with study requirements.
22. Subject was enrolled after the maximum number of targeted subjects were randomized into the respective disease or UUI group.

Primary outcomes:
measure: Neurogenic Bladder Symptom Score (NBSS)
timeFrame: 12 weeks
Secondary outcomes:
measure: Urge Urinary Incontinence Episodes
timeFrame: 12 weeks
measure: Patient Global Improvement Index (PGI-I)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Downey
country: United States
facility: Rancho Research Institute
state: California
city: San Diego
country: United States
facility: UC San Diego Health Systems
state: California
city: Denver
country: United States
facility: Craig Hospital
state: Colorado
city: Washington DC
country: United States
facility: Medstar National Rehab
state: District of Columbia
city: Miami
country: United States
facility: University of Miami, Desai Sehti Urology Institute
state: Florida
city: Atlanta
country: United States
facility: Shepherd Centre
state: Georgia
city: Cambridge
country: United States
facility: Spaulding Rehabilitation Hospital Cambridge
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic, St. Mary's Campus
state: Minnesota
city: New York
country: United States
facility: Columbia University Irving Medical Centre
state: New York
city: Charlotte
country: United States
facility: Atrium Health
state: North Carolina
city: Vancouver
country: Canada
facility: ICORD Vancouver
state: British Colombia
city: New Delhi
country: India
facility: Insitute of Brain and Spine
Study officials:
References: