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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;
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3, 6,12 months
Awards & highlights

PROTECT Trial Summary

This trial will compare two medical devices for treating urinary incontinence. One hundred and fifty people will be randomly assigned to use either the Protect CAN-Stim or the InterStim® system. The primary endpoint is a 50% reduction in the number of incontinence episodes at 3 months.

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.Check my eligibility
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.See study design
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.

PROTECT Trial 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 am 18 years old or older.
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I am of childbearing age and agree to use birth control.
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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 antidepressant dose has been stable for 3 months.
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My kidney function is normal based on my medical history.
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I understand the study and can agree to participate.
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I am willing and able to follow all study procedures.
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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.
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My doctor thinks I am a good candidate for surgery.

PROTECT Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Reduction in degree of urgency
Response rate: a ≥ 50% reduction in number of urgency related incontinence episodes
Voiding Frequency
+1 more
Other outcome measures
AE's
Episodes
Improvement
+3 more

PROTECT 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.

Find a Location

Who is running the clinical trial?

Micron Medical CorporationLead Sponsor
4 Previous Clinical Trials
660 Total Patients Enrolled
Uro Medical CorporationLead Sponsor
5 Previous Clinical Trials
670 Total Patients Enrolled

Media Library

CAN-Stim - Protect CAN-Stim System (Neuromodulation Device) Clinical Trial Eligibility Overview. Trial Name: NCT02577302 — N/A
Urge Urinary Incontinence Research Study Groups: CAN-Stim Group - CAN-Stim System, SNS Group - Interstim® System
Urge Urinary Incontinence Clinical Trial 2023: CAN-Stim - Protect CAN-Stim System Highlights & Side Effects. Trial Name: NCT02577302 — N/A
CAN-Stim - Protect CAN-Stim System (Neuromodulation Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02577302 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the enrollment rate for this clinical trial?

"To effectively evaluate the efficacy of this treatment, a total of 200 individuals who meet the criteria must partake in the trial. The study is taking place at University of California Irvine Medical Center (Orange, CA) and Westview Clinical Research (Placentia, MI)."

Answered by AI

Are there any available openings for individuals to participate in this clinical investigation?

"Accurately, clinicaltrials.gov contains data that states this medical trial is still accepting patients. The study was first published on June 21st 2018 and the most recent edit to it happened July 20th 2022. 200 volunteers are being enrolled from 13 distinct sites."

Answered by AI

How many healthcare facilities are participating in the execution of this experiment?

"Currently, there are 13 clinical trial sites actively recruiting patients. These include the University of California Irvine Medical Center in Orange, Westview Clinical Research in Placentia, and William Beaumont Hospital in Royal Oak; as well as 10 other locations across the United States."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
University of California Irvine Medical Center
Advanced Urology Institute
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

Using a condom catheter for last 10 years due to a spinal cord injury.
PatientReceived 2+ prior treatments

How responsive is this trial?

Most responsive sites:
  1. University of California Irvine Medical Center: < 48 hours
Average response time
  • < 2 Days
Typically responds via
Phone Call
~39 spots leftby Oct 2025