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CAN-Stim vs InterStim for Urinary Incontinence (PROTECT Trial)
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.
PROTECT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowPROTECT Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.PROTECT Trial Design
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- Your bladder still has more than 150 cc of urine left after you pee.You go to the bathroom at least 10 times a day.You have a condition that needs an MRI or diathermy procedure.You need to have an average urgency score of at least 2 on a 3-day bladder diary.I have diabetes with nerve issues or my diabetes is not well-controlled (HbA1C 8.5 or higher).I have a history of bleeding or clotting disorders.My body cannot accommodate the placement of a medical device due to its structure.I need help to understand and fill out questionnaires.You have at least 4 episodes of urgent bladder leakage recorded in a 3-day log.I've had at least 4 urgent incontinence episodes in 3 days.I have had bladder symptoms for more than 6 months.My kidney function is normal.I experience urine leakage when I cough, sneeze, or exercise.I have a bladder condition due to a neurological disorder.I am 18 years old or older.I have spinal hardware that may block access to my sacrum.I have not used Botox in my bladder or pelvic muscles in the last 9 months.I haven't had nerve or muscle stimulation treatments for my pelvic area in the last 60 days.I am willing and able to follow all study procedures.I have been diagnosed with overactive bladder with mostly urge-related symptoms.I am of childbearing age and agree to use birth control.I have had bladder symptoms for more than 6 months.My first and second treatments for my condition did not work.My antidepressant dose has been stable for 3 months.My kidney function is normal based on my medical history.I understand the study and can agree to participate.I currently have a urinary tract infection.I have been considered unsuitable for this trial by a doctor due to my medical history or current health condition.You urinate at least 10 times a day.I have had sacral neuromodulation therapy before.You are unable to use the CAN-Stim System or InterStim System.You rely on a wearable or other medical device for treating a health condition.I haven't taken any antimuscarinic or beta-3 adrenergic agonist medications for the last 2 weeks.I don't have any blockages or stones in my bladder or urethra, nor do I have a bladder tumor.I have not been in a study affecting my kidney function in the last 30 days.My doctor thinks I am a good candidate for surgery.You are expected to live for less than 1 year.You have a surgically implanted electronic device that is still working, even if it's not turned on.I have a history of severe pelvic pain.
- Group 1: CAN-Stim Group - CAN-Stim System
- Group 2: SNS Group - Interstim® System
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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)."
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."
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."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
How responsive is this trial?
Most responsive sites:
- University of California Irvine Medical Center: < 48 hours
Average response time
- < 2 Days
Typically responds via
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