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

Korábbi kezelés

• Subject has a history of bladder augmentation or continent or incontinent urinary stoma or prior bladder surgery.
• Subject has a concurrent neurological disease affecting the central nervous system, other than spinal cord injury or multiple sclerosis or stroke.
• Subject has received intravesical botulinum toxin injection within 12 months preceding enrollment.
• 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.

Más betegség

• Subject is dependent on an electromagnetic medical implant (e.g., cardiac pacemaker or implanted drug pump), ventilation support, or other external device.
• Subject has history of morphologic bladder outlet obstruction (e.g., due to benign prostatic hyperplasia, urethral stricture and /or bladder neck contracture).
• 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 was enrolled after the maximum number of targeted subjects were randomized into the respective disease or UUI group.

Laborértékek

• 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).

Életkor

• For non catheterizing male subjects older than 55 years of age, screening responses consistent with benign prostatic hyperplasia.

Egyéb

• Subject relies on an indwelling catheter (urethral or suprapubic) for bladder drainage.
• 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's BMI is > 35.
• 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.
• 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 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 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.