Spinal Cord Neuromodulator by SpineX and Scone to Treat Neurogenic Bladder
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
• 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.