Home › Trials › NCT02577302

Comparing CAN-Stim and SNS for treating urinary urgency incontinence

Multi-center, Prospective, Randomized, Controlled, Non-Inferiority, Clinical Trial of Chronic Afferent Nerve Stimulation (CAN-Stim) of the Tibial Nerve Versus Sacral Nerve Stimulation (SNS) in the Treatment of Urinary Urgency Incontinence Resulting From Refractory Overactive Bladder (OAB)

Not applicable Interventional Uro Medical Corporation · NCT02577302

This study is testing whether a new device called Protect CAN-Stim works better than the SNS InterStim® system to help people with urinary urgency incontinence have fewer accidents.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment200 (estimated)
Ages18 Years and up
SexAll
SponsorUro Medical Corporation Industry-sponsored
Locations15 sites (Laguna Hills, California and 14 other locations)
Trial IDNCT02577302 on ClinicalTrials.gov

What this trial studies

This clinical trial is a prospective, randomized, controlled, multi-center study involving 150 subjects who will be assigned to receive either the Protect CAN-Stim or the SNS InterStim® system for the treatment of urinary urgency incontinence. Participants will undergo implantation of the device and will be monitored for a minimum of 12 months, with primary outcomes assessed at 3 months. The study aims to evaluate the effectiveness of these neuromodulation technologies by measuring the reduction in incontinence episodes associated with urgency. Subjects will be educated on device usage and programming adjustments will be made to optimize therapeutic response.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with a diagnosis of overactive bladder and a history of urgency urinary incontinence.

Not a fit: Patients with active urethral obstruction, bladder tumors, or those who have not failed previous therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients suffering from urinary urgency incontinence.

How similar studies have performed: Other studies have shown promise with neuromodulation approaches for urinary incontinence, suggesting potential for success in this trial.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Diagnosis of overactive bladder with urgency urinary incontinence or mixed incontinence (urge and stress) with predominate urge, as confirmed by the MESA questionnaire;
* Women and men ≥ 18 years of age;
* Women of child-bearing age willing to practice birth control;
* At least 4 incontinent episodes associated with urgency on a 3-day voiding diary;
* At least 10 voids per day;
* Average urgency score of at least 2 as measured with IUSS on a 3-day voiding diary;
* Self-reported bladder symptoms present \> 6 months;
* Documented failure of an adequate trial of first and second line therapy;
* Off all antimuscarinics and beta-3 adrenergic agonists for at least 2 weeks prior to enrollment;
* If on Tricyclic antidepressants, dosage must be stabilized for at least 3 months;
* Have no active urethral obstruction/stricture, bladder calculi or bladder tumor based on medical history;
* Normal upper urinary tract function based on medical history;
* Based on the medical opinion of the Investigator, there is no evidence of anatomic abnormalities that could jeopardize the placement of the device or pose a hazard to the subject;
* Based on the medical opinion of the Investigator, subject is willing and able to operate the patient programmer, recharging equipment, diary and has the ability to undergo study assessments and provide accurate responses;
* Based on the medical opinion of the Investigator, subject is a good surgical subject for the implant procedure;
* Capable of giving informed consent;
* Capable and willing to follow all study related procedures.

Exclusion Criteria:

* An active implantable electronic device regardless of whether stimulation is ON or OFF;
* Pregnant as confirmed by a urine pregnancy test or plan to become pregnant during the following 12 months period;
* Primary complaint of stress urinary incontinence;
* Less than 1 year post-partum and/or are breast-feeding;
* Neurogenic bladder (i.e. Multiple sclerosis, Parkinson's, Spinal Cord Injury);
* Patients with spinal hardware that would limit access to the sacrum;
* Botox use in bladder or pelvic floor muscles in the past nine months;
* Have a post-void residual urine volume \>150 cc at baseline;
* Current urinary tract infection (UTI);
* Previous treatment with sacral neuromodulation;
* Previous treatment with percutaneous tibial nerve stimulation, pelvic floor muscle stimulation, or biofeedback within the past 60 days;
* Conditions requiring Magnetic Resonance Imaging (MRI) evaluation or diathermy procedures;
* Inability to operate the CAN-Stim System or InterStim System;
* Diabetes with peripheral nerve compromise or severe uncontrolled diabetes (HbA1C 8.5 or greater);
* History of coagulopathy or bleeding disorder;
* History of pelvic pain as primary diagnosis (VAS score of \> 4) at baseline;
* Anatomical restrictions such that device placement is not possible;
* Are currently participating or have participated within the past 30 days in any clinical investigation involving or impacting urinary or renal function;
* Have a life expectancy of less than 1 year;
* Cannot independently comprehend and complete the questionnaires and diaries;
* Deemed unsuitable for enrollment by the investigator based on history or physical examination (including bleeding disorders or anticoagulant medications, and peripheral neuropathy);
* Dependent on wearable, transcutaneous, or other therapeutic medical device (examples: glucose monitor, TENS) for treatment of a disease or disorder.

Where this trial is running

Laguna Hills, California and 14 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Urinary Incontinence, UrgeChronic Tibial nerve stimulationWireless PNSneuromodulation
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.