Spinal COrd NeuromodulaTor by SpIneX and ScoNE to Treat NeurogeniC BladdEr - SCONE "CONTINENCE" Clinical Study

Inclusion Criteria:

1. Subject is ≥ 18 and ≤ 70 years old (male subjects) or ≥ 18 and ≤ 75 years (femalesubjects) 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 scaleOR

• Chronic, spinal cord injury at C3 to L1 classified as ASIA C-D on the AIS scaleOR

• Multiple sclerosis; OR

• Stroke

3. Subject has symptoms of urinary urgency (> 50% high urge voids) or increasedfrequency of micturition/self-catheterization (more than once every 2 hours) orincontinence 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 ofenrollment (consent).

7. Subject's medical condition is stable.

8. Subject has adequate social support network to be able to participate in trainingand assessment sessions for the duration of the study, at the discretion of theInvestigator.

9. Subject has been informed of the nature of the study, can understand therequirements of the study, agrees to participate, and has signed theIRB/REB/EC-approved informed consent.

Exclusion Criteria:

1. Subject relies on an indwelling catheter (urethral or suprapubic) for bladderdrainage.

2. Subject has a history of bladder augmentation or continent or incontinent urinarystoma or prior bladder surgery.

3. Subject has congestive heart failure, pulmonary disease necessitating supplementaloxygen use, chronic kidney disease (Stage III or higher), chronic liver disease (Child Pugh class B or C) or poorly controlled diabetes (if diabetic, HbA1c > 8.0within 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) morethan once a week.

7. Subject is dependent on an electromagnetic medical implant (e.g., cardiac pacemakeror implanted drug pump), ventilation support, or other external device.

8. Subject has received intravesical botulinum toxin injection within 12 monthspreceding enrollment.

9. Subject's BMI is > 35.

10. Subject has history of morphologic bladder outlet obstruction (e.g., due to benignprostatic hyperplasia, urethral stricture and /or bladder neck contracture).

11. Subject has history of frequent symptomatic urinary tract infections, defined asreceiving five or more courses of urinary tract infection directed antibioticswithin 12 months prior to enrollment.

12. For non catheterizing subjects, post void residual is > 100 mL measured by bladderultrasound, bladder scanner, or one time catheterization at the time of enrollment

13. For female subjects, history and/or screening responses consistent with pelvic organprolapse.

14. For non catheterizing male subjects older than 55 years of age, screening responsesconsistent with benign prostatic hyperplasia.

15. Subjects with significant stress incontinence (> 3 stress incontinence episodes perday), 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/psychologicalproblems, or cognitive impairments that, in the opinion of the Investigator, willpreclude them from participation and completion of study procedures or requirements.

18. Subject has a medical condition or complications related to the use of certainmedications 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 asdetermined by the Investigator.

20. Subject is participating in or plans to participate in another research study thatmay interfere with study endpoints.

21. Subject is known or suspected to be non compliant; and/or subject is unable orunwilling to comply with study requirements.

22. Subject was enrolled after the maximum number of targeted subjects were randomizedinto the respective disease or UUI group.