CAN-Stim vs InterStim for Urinary Incontinence

(PROTECT Trial)

Recruiting at13 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Micron Medical Corporation

Must not be taking: Antimuscarinics, Beta-3 agonists

Disqualifiers: Pregnancy, Neurogenic bladder, Diabetes, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

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.

What data supports the effectiveness of the treatment CAN-Stim - Protect CAN-Stim System, Protect CAN-Stim System, SNS - InterStim® System, InterStim, Sacral Nerve Stimulation for urinary incontinence?

Research shows that sacral nerve stimulation, like the InterStim system, is effective for urinary incontinence. In a study, 59% of patients with urinary urge incontinence experienced more than a 50% reduction in leaking episodes after three years, with 46% becoming completely dry. ^{1 2 3 4 5}

How does the CAN-Stim treatment for urinary incontinence differ from other treatments?

The CAN-Stim treatment, like the InterStim system, uses sacral nerve stimulation (SNS) to help control urinary incontinence by modulating nerve signals to the bladder. This approach is unique because it targets the nerves directly, unlike traditional medications or surgeries, and is used when other treatments have not been effective. ^{1 3 5 6 7}

Research Team

Eligibility Criteria

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.

Inclusion Criteria

You go to the bathroom at least 10 times a day.

You need to have an average urgency score of at least 2 on a 3-day bladder diary.

You have at least 4 episodes of urgent bladder leakage recorded in a 3-day log.

Exclusion Criteria

Less than 1 year post-partum and/or are breast-feeding

Your bladder still has more than 150 cc of urine left after you pee.

You have a condition that needs an MRI or diathermy procedure.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either CAN-Stim or SNS InterStim® system therapy, with device implantation and initial programming for a minimum of 8 hours per day for 2 weeks

2 weeks

1 visit (in-person) for implantation, 1 visit (in-person) for 2-week follow-up

Extended Treatment

Responders continue therapy with monitoring and programming adjustments as needed, with primary outcomes assessed at 3 months

3 months

1 visit (in-person) at 3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 6, 9, and 12 months

9 months

3 visits (in-person) at 6, 9, and 12 months

Treatment Details

Interventions

• CAN-Stim - Protect CAN-Stim System (Neuromodulation Device)
• SNS - InterStim® System (Neuromodulation Device)

Trial Overview 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.

Participant Groups

Group I: CAN-Stim Group - CAN-Stim System Experimental Treatment 1 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® System Active Control 1 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.

Who Is Running the Clinical Trial?

Micron Medical Corporation

Lead Sponsor

Trials

5

Recruited

860+

Uro Medical Corporation

Lead Sponsor

Trials

6

Recruited

870+

Findings from Research

In a study of 36 women with refractory urge urinary incontinence (UUI) receiving sacral nerve stimulation (SNS), 83% reported bowel dysfunction, highlighting the prevalence of this issue in this patient group.

SNS significantly improved urinary symptoms and quality of life (QOL) scores, but while bowel symptoms improved, these changes did not lead to significant improvements in bowel-related QOL.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvement of bowel dysfunction with sacral neuromodulation for refractory urge urinary incontinence. Gill, BC., Swartz, MA., Rackley, RR., et al.[2021]

A survey of 31 high-volume providers of sacral neuromodulation revealed that 100% administered preoperative antibiotics, with cefazolin and vancomycin being the most common choices, highlighting a strong emphasis on infection prevention during surgery.

Despite the high rates of antibiotic use, only 13% of providers routinely screened for methicillin-resistant Staphylococcus aureus, indicating a potential gap in infection control practices that warrants further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

National Practice Patterns of Infection Prophylaxis for Sacral Neuromodulation Device: A Survey of High Volume Providers. Lee, EW., Lucioni, A., Lee, UJ., et al.[2023]

InterStim™ therapy has evolved from an open surgical procedure to a minimally invasive technique, significantly improving its safety and efficacy for treating faecal incontinence since its introduction in 1995.

Recent advancements, such as the smaller neurostimulator and self-anchoring tined lead, have enhanced patient comfort and reduced technical failures, leading to a success rate improvement in the test phase from 60% to 80%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fifteen years of sacral nerve stimulation: from an open procedure to a minimally invasive technique. Hetzer, FH.[2022]

In a study of 23 children aged 6 to 15 with severe dysfunctional elimination syndrome, sacral nerve stimulation (InterStim) showed significant effectiveness, with 68% of patients experiencing improvement in urinary incontinence and 56% in nocturnal enuresis after a mean follow-up of 13.3 months.

The procedure led to a reduction in postoperative medication use by an average of 3 medications per patient, indicating a positive impact on overall management of symptoms, although some complications were noted, including device failures and skin sensitivity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary results of sacral neuromodulation in 23 children. Humphreys, MR., Vandersteen, DR., Slezak, JM., et al.[2006]

Sacral nerve stimulation using the InterStim system is an established treatment for lower urinary tract disorders, particularly effective for detrusor overactivity and severe voiding difficulties in women.

Despite its acceptance, the technique is still developing, with ongoing research needed to understand its mechanisms, optimize stimulation delivery, and better define clinical indications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuromodulation for lower urinary tract dysfunction--an update. Hussain, Z., Harrison, SC.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

Long-term results of a multicenter study on sacral nerve stimulation for treatment of urinary urge incontinence, urgency-frequency, and retention. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Improvement of bowel dysfunction with sacral neuromodulation for refractory urge urinary incontinence. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

National Practice Patterns of Infection Prophylaxis for Sacral Neuromodulation Device: A Survey of High Volume Providers. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Fifteen years of sacral nerve stimulation: from an open procedure to a minimally invasive technique. [2022]

5. Scotland pubmed.ncbi.nlm.nih.gov

Sacral nerve stimulation for urinary dysfunction: the first year of the Scottish national service. [2015]

6. United States pubmed.ncbi.nlm.nih.gov

Preliminary results of sacral neuromodulation in 23 children. [2006]

7. United States pubmed.ncbi.nlm.nih.gov

Neuromodulation for lower urinary tract dysfunction--an update. [2018]