CAN-Stim vs InterStim for Urinary Incontinence

(PROTECT Trial)

This trial tests two devices designed to help people with urinary incontinence, a condition where bladder control is lost, leading to sudden urges. The study compares the CAN-Stim System (Protect CAN-Stim System) and the InterStim® System (Sacral Nerve Stimulation) to determine which device more effectively reduces incontinence episodes. Participants must experience at least four episodes of urgency-related incontinence over three days and have tried other treatments without success. As an unphased trial, this study allows participants to contribute to important research that could enhance future treatment options for urinary incontinence.

The trial requires participants to stop taking antimuscarinics and beta-3 adrenergic agonists at least 2 weeks before joining. If you're on tricyclic antidepressants, your dosage must be stable for at least 3 months before enrolling.

Research shows that both the CAN-Stim and InterStim devices have been studied for treating urinary incontinence, with safety information available for both.

For the CAN-Stim system, earlier studies have shown encouraging results. One study with 46 patients reported a 71% reduction in incontinence episodes over six months. This suggests the device is generally well-tolerated, although specific details on side effects during this period are not provided in the available sources.

The InterStim system has been used for a longer period and is FDA-approved for treating urinary issues like incontinence. In one study, 120 patients experienced successful outcomes with this device, and safety data from long-term use (36 months) supported its effectiveness and safety. The most common side effects for InterStim users include pain at the implant site and discomfort from the device, but these are usually manageable.

Researchers are excited about the CAN-Stim System for treating urinary incontinence because it offers a fresh approach compared to traditional treatments like medication or the existing InterStim® System. Unlike the InterStim, which involves placing a lead in the sacral foramen, CAN-Stim uses a tibial medical device, potentially offering a less invasive alternative. This unique delivery through the tibial nerve might lead to fewer complications and a simpler implantation process. Additionally, CAN-Stim could provide patients with a more comfortable experience while still effectively managing symptoms of urinary incontinence.

This trial will compare the effectiveness of the Protect CAN-Stim System and the SNS InterStim® System for treating urinary incontinence. Research has shown that the Protect CAN-Stim System, which participants in one arm of this trial will receive, led to over 67% of patients experiencing more than a 50% reduction in incontinence episodes after 6 months. In contrast, the SNS InterStim® System, which participants in another arm of this trial will receive, has long-term data indicating that 59% of patients experienced a significant reduction in leakage episodes after 3 years. Another study found that 82% of SNS patients noticed improvements, with 37% becoming completely dry. Both treatments send electrical pulses to nerves, helping control bladder function. This evidence suggests that both CAN-Stim and SNS InterStim® can effectively reduce urinary incontinence.¹²³⁴⁶