SCONE Therapy for Neurogenic Bladder
(CONTINENCE Trial)
Trial Summary
What is the purpose of this trial?
This trial is testing a treatment called SCONE neuromodulation therapy, which uses electrical or magnetic signals to help nerves work better. It aims to improve bladder problems in people whose bladder issues are caused by nerve problems. The study will compare this treatment to another to see if it is safe and effective. SCONE™ therapy represents the first of its kind therapy to treat symptoms of urgency, frequency, and urge urinary incontinence in patients with OAB.
Research Team
Eligibility Criteria
This trial is for adults aged 18-70 (75 for females) with stable medical conditions and a support network. They must have neurogenic lower urinary tract dysfunction due to spinal cord injury, multiple sclerosis, or stroke, and be at least one year post-diagnosis. Participants need symptoms like urgency or frequent urination/incontinence and no significant autonomic dysreflexia, severe heart/kidney/liver disease, other CNS diseases besides the qualifying ones, morphologic bladder obstruction history, or reliance on indwelling catheters.Inclusion Criteria
Exclusion Criteria
Treatment Details
Interventions
- SCONE (Neuromodulation)
Find a Clinic Near You
Who Is Running the Clinical Trial?
SpineX Inc.
Lead Sponsor
Craig Hospital, Englewood, Colorado, United States
Collaborator
University of Miami, Miami, United States
Collaborator
Shepherd Center, Atlanta, Georgia, United States
Collaborator
Mayo Clinic, Rochester, Minnesota, United States
Collaborator
MedStar National Rehabilitation Network, Washington, District of Columbia, United States
Collaborator
Institute of Brain and Spine (IBS Hospital), New Delhi, India
Collaborator
Rancho Los Amigos National Rehabilitation Center, Downey, California, United States
Collaborator
Spaulding Rehabilitation Hospital, Charlestown, Massachusetts, United States
Collaborator
University of California, San Diego, California United States
Collaborator