Spinal COrd NeuromodulaTor by SpIneX and ScoNE to Treat NeurogeniC BladdEr - SCONE "CONTINENCE" Cā¦ (NCT05301335) | Clinical Trial Compass
CompletedNot Applicable
Spinal COrd NeuromodulaTor by SpIneX and ScoNE to Treat NeurogeniC BladdEr - SCONE "CONTINENCE" Clinical Study
United States126 participantsStarted 2022-05-25
Plain-language 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
Who can participate
Age range18 Years ā 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
ā. Subject is ā„ 18 and ā¤ 70 years old (male subjects) or ā„ 18 and ā¤ 75 years (female subjects) at the time of enrollment/consent.
ā. Subject has a diagnosis of NLUTD due to:
ā. 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).
ā. Subject has sterile urine or asymptomatic bacteriuria.
ā. Subject's score is \> 28 on NBSS survey.
ā. Subject is at least one year post initial diagnosis of NLUTD at the time of enrollment (consent).
ā. Subject's medical condition is stable.
ā. 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.
Exclusion criteria
ā. Subject relies on an indwelling catheter (urethral or suprapubic) for bladder drainage.
ā. Subject has a history of bladder augmentation or continent or incontinent urinary stoma or prior bladder surgery.
ā. 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).
ā. Subject has a concurrent neurological disease affecting the central nervous system, other than spinal cord injury or multiple sclerosis or stroke.
ā. Subject has an implanted central or peripheral neuromodulator.
ā. Subject has symptomatic, clinically significant autonomic dysreflexia attacks (characterized by headache and systolic blood pressure greater than 180 mmHg) more than once a week.
ā. Subject is dependent on an electromagnetic medical implant (e.g., cardiac pacemaker or implanted drug pump), ventilation support, or other external device.
ā. Subject has received intravesical botulinum toxin injection within 12 months preceding enrollment.