What side effects are associated with this type of intervention?

Neuromodulation treatments for Urge Urinary Incontinence, such as Protect CAN-Stim and SNS InterStim® systems, commonly have side effects that include pain at the implant site, infection, lead migration, and technical issues with the device. Patients may also experience changes in bowel function, discomfort during stimulation, and, in rare cases, nerve damage. It is important for patients to discuss these potential risks with their healthcare provider to make an informed decision.

What prior FDA approvals exist?

The FDA has approved several neuromodulation devices for the treatment of Urge Urinary Incontinence (UUI). The InterStim® system by Medtronic is a well-known sacral neuromodulation (SNS) device that has been approved for treating UUI by modulating the sacral nerves to improve bladder control. Another similar device is the Axonics® Sacral Neuromodulation System, which also targets the sacral nerves to manage symptoms of UUI. These devices work by delivering electrical impulses to the nerves that control the bladder, thereby reducing incontinence episodes. While specific drug approvals were not detailed, these neuromodulation devices represent significant advancements in the management of UUI.

What other types of research exist?

Promising novel alternatives for treating Urge Urinary Incontinence in 2024 include: 1) Percutaneous Tibial Nerve Stimulation (PTNS), which involves stimulating the tibial nerve to improve bladder control. 2) Miniaturized, endoscopically-delivered gastric electrical stimulators, which are being developed for other conditions but may have potential applications in UUI. 3) Advanced multi-channel neuromodulation devices that offer more precise and customizable stimulation patterns. These alternatives are in various stages of research and development and may provide new options for patients with UUI.

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Neuromodulation Device

CAN-Stim vs InterStim for Urinary Incontinence (PROTECT Trial)

N/A

Recruiting

Research Sponsored by Micron Medical Corporation

Eligibility Criteria Checklist

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

Must have

At least 4 incontinent episodes associated with urgency on a 3-day voiding diary;

Self-reported bladder symptoms present > 6 months;

Must not have

Diabetes with peripheral nerve compromise or severe uncontrolled diabetes (HbA1C 8.5 or greater)

History of coagulopathy or bleeding disorder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3, 6,12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests two devices, Protect CAN-Stim and SNS InterStim®, which send electrical pulses to nerves to help reduce urgent incontinence episodes. It targets patients who frequently experience urgent incontinence and have not responded well to other treatments. The devices work by regulating the nerves that control bladder function.

Who is the study for?

This trial is for adults over 18 with urge urinary incontinence or mixed incontinence, experiencing at least four urgency episodes and ten voids per day. Candidates must not be on certain bladder medications, have stable health without obstructions or tumors in the urinary tract, and women must use birth control. Exclusions include those with electronic implants, recent pelvic treatments, severe diabetes, bleeding disorders, or a need for MRI.

What is being tested?

The study compares two devices: Protect CAN-Stim System versus InterStim® System for treating urinary urgency incontinence. Participants are randomly assigned to one of these treatments and will start therapy immediately. Success is measured by a significant reduction of urgency-related incontinence episodes after three months.

What are the potential side effects?

Potential side effects may include discomfort at the implant site, device malfunctions leading to abnormal sensations or pain during stimulation sessions; however specific side effects related to each system are not detailed here.

Eligibility Criteria

Inclusion Criteria

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

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I've had at least 4 urgent incontinence episodes in 3 days.

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I have had bladder symptoms for more than 6 months.

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My kidney function is normal.

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I have been diagnosed with overactive bladder with mostly urge-related symptoms.

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I have had bladder symptoms for more than 6 months.

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My first and second treatments for my condition did not work.

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My kidney function is normal based on my medical history.

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I haven't taken any antimuscarinic or beta-3 adrenergic agonist medications for the last 2 weeks.

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I don't have any blockages or stones in my bladder or urethra, nor do I have a bladder tumor.

Exclusion Criteria

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

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I have diabetes with nerve issues or my diabetes is not well-controlled (HbA1C 8.5 or higher).

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I have a history of bleeding or clotting disorders.

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My body cannot accommodate the placement of a medical device due to its structure.

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I need help to understand and fill out questionnaires.

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I experience urine leakage when I cough, sneeze, or exercise.

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I have a bladder condition due to a neurological disorder.

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I have spinal hardware that may block access to my sacrum.

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I currently have a urinary tract infection.

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I have had sacral neuromodulation therapy before.

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I have a history of severe pelvic pain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3, 6,12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3, 6,12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3, 6,12 months for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Reduction in degree of urgency

Response rate: a ≥ 50% reduction in number of urgency related incontinence episodes

Voiding Frequency

+1 more

Other study objectives

AE's

Episodes

Improvement

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: CAN-Stim Group - CAN-Stim SystemExperimental Treatment1 Intervention

Intervention: tibial medical device Subjects randomized to this group will have the Protect CAN-Stim System tibial medical device implanted for the duration of the study.

Group II: SNS Group - Interstim® SystemActive Control1 Intervention

Intervention: SNS Medical device Subjects randomized to SNS will have their Stage I device implanted and tested during a 2-week period. Stage I will have a tined, quadripolar lead placed in the S3 (preferred) or S4 (alternate) foramen in the standard fashion using fluoroscopic guidance and motor response. Motor responses can include a contraction of the levators ("bellows" response) with or without plantar flexion of the great toe. Subjects who are not demonstrating an appropriate motor response will not have the device implanted and will be exited from the study.

0 / 19Eligibility 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, such as the Protect CAN-Stim and SNS InterStim® systems, treat Urge Urinary Incontinence (UUI) by stimulating specific nerves to improve bladder control. The SNS InterStim® system targets the sacral nerves, particularly the S3 nerve, which modulates the neural pathways controlling bladder sensation and contraction, thereby reducing incontinence episodes. The Protect CAN-Stim system likely operates similarly, aiming to enhance bladder control through targeted nerve stimulation. These mechanisms are crucial for UUI patients as they directly influence neural control of the bladder, potentially reducing symptoms and improving quality of life.

Effects of acute sacral neuromodulation on bladder reflex in complete spinal cord injury rats.Influence of sacral neuromodulation on electrosensation of the lower urinary tract.