What is the mechanism of action of this treatment?

Neuromodulation therapies for Multiple Sclerosis (MS) aim to alter nerve activity to improve symptoms such as urinary tract dysfunction. Techniques like spinal cord stimulation use electrical impulses to modulate nerve signals, potentially reducing pain and improving bladder control. Intrathecal baclofen infusions and botulinum toxin injections target spasticity by inhibiting neurotransmitter release, thereby relaxing muscles. These treatments are crucial for MS patients as they address debilitating symptoms, enhancing quality of life and functional independence.

What side effects are associated with this type of intervention?

Neuromodulation therapies for Multiple Sclerosis, such as spinal cord stimulation and other electrical stimulation techniques, are generally considered safe but can have side effects. Common side effects include discomfort or pain at the site of electrode placement, infection, and hardware complications such as lead migration or breakage. Some patients may also experience changes in sensation or muscle spasms. It is important to discuss these potential risks with a healthcare provider to determine the best treatment approach.

What prior FDA approvals exist?

The FDA has approved several treatments for Multiple Sclerosis (MS) that focus on altering nerve activity, although not specifically for urinary tract function. One notable example is spinal cord stimulation, which has been used to manage chronic pain in MS patients. Additionally, treatments like intrathecal baclofen infusions and botulinum toxin injections have been used to manage spasticity and bladder dysfunction in MS. While these treatments are not identical to the SCONE neuromodulation therapy being studied, they share the common goal of modulating nerve activity to alleviate symptoms.

What other types of research exist?

Promising novel alternatives to SCONE neuromodulation therapy for Multiple Sclerosis patients include: 1) Sacral nerve stimulation, which involves placing a small wire under the skin to send mild electrical pulses to nerves controlling bladder function. 2) Posterior tibial nerve stimulation (PTNS), which uses transcutaneous needle nerve stimulation near the ankle to reduce urinary symptoms. Both techniques have shown efficacy in improving urinary tract function and may be considered as alternatives.

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Neuromodulation

SCONE Therapy for Neurogenic Bladder (CONTINENCE Trial)

N/A

Recruiting

Research Sponsored by SpineX Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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 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

Must not have

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 history of bladder augmentation or continent or incontinent urinary stoma or prior bladder surgery.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

Summary

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.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

While specific side effects are not listed here, participants should consider potential risks associated with neuromodulation therapies such as discomfort at the stimulation site, infection risk from implanted devices if any are used, possible interference with bodily functions controlled by nerves involved in the treatment area.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I have bladder dysfunction due to a spinal cord injury or a condition like MS or stroke.

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

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I have bladder dysfunction due to a spinal injury, multiple sclerosis, or stroke.

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I am a man between 18 and 70 years old or a woman between 18 and 75 years old.

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I have a spinal cord injury between C3-T8, multiple sclerosis, or have had a stroke.

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My bladder muscle involuntarily contracts strongly.

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I am between 18 and 70 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have serious heart, lung, kidney, liver problems, or my diabetes is not well-controlled.

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I have had surgery on my bladder or have a urinary stoma.

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I have had 5 or more UTI treatments in the last year.

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I have had blockages in my bladder outlet due to conditions like an enlarged prostate.

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I experience significant urine leakage during activities like coughing or sneezing more than 3 times a day.

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I have a brain or nerve condition that is not a spinal cord injury, MS, or stroke.

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I experience severe headaches and high blood pressure over 180 mmHg more than once a week.

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I am a man over 55 with symptoms of an enlarged prostate.

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I have or might have pelvic organ prolapse.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Neurogenic Bladder Symptom Score (NBSS)

Secondary study objectives

Patient Global Improvement Index (PGI-I)

Urge Urinary Incontinence Episodes

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Therapeutic ArmExperimental Treatment1 Intervention

Group II: Sham ArmPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

SCONE

2022

N/A

~10

0 / 17Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Neuromodulation therapies for Multiple Sclerosis (MS) aim to alter nerve activity to improve symptoms such as urinary tract dysfunction. Techniques like spinal cord stimulation use electrical impulses to modulate nerve signals, potentially reducing pain and improving bladder control. Intrathecal baclofen infusions and botulinum toxin injections target spasticity by inhibiting neurotransmitter release, thereby relaxing muscles. These treatments are crucial for MS patients as they address debilitating symptoms, enhancing quality of life and functional independence.