Spinal Cord Neuromodulator by SpineX and Scone to Treat Neurogenic Bladder

SpineX Inc.12 sites in 3 countries126 target enrollmentMay 25, 2022

ConditionsNeurogenic Bladder Spinal Cord Injuries (Complete and Incomplete)Stroke Multiple Sclerosis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Neurogenic Bladder
Sponsor: SpineX Inc.
Enrollment: 126
Locations: 12
Primary Endpoint: Neurogenic Bladder Symptom Score (NBSS)
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

May 25, 2022

End Date

May 1, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

SpineX Inc.

Responsible Party

Sponsor

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
•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.

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 \>
•Subject has history of morphologic bladder outlet obstruction (e.g., due to benign prostatic hyperplasia, urethral stricture and /or bladder neck contracture).