SCONE Therapy for Neurogenic Bladder
(CONTINENCE Trial)

Recruiting in Palo Alto (17 mi)

+13 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: SpineX Inc.

No Placebo Group

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.

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

Your score on the NBSS survey is higher than 28.

I understand the study, agree to participate, and have signed the consent form.

I often feel a strong need to urinate or need to use the bathroom more than once every 2 hours.

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Exclusion Criteria

I have had a bladder botox injection in the last year.

Subject is pregnant or trying to become pregnant; or is nursing.

Subject is known or suspected to be non compliant; and/or subject is unable or unwilling to comply with study requirements.

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Treatment Details

Interventions

SCONE (Neuromodulation)

Trial OverviewThe SCONE 'CONTINENCE' study tests if SCONE neuromodulation therapy can improve symptoms of Neurogenic Lower Urinary Tract Dysfunction after 12 weeks compared to a sham control. It's designed to see how effective and safe this treatment is in managing issues like urinary urgency and incontinence.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Therapeutic ArmExperimental Treatment1 Intervention

Group II: Sham ArmPlacebo Group1 Intervention