CAN-Stim Compared to SNS in Treatment of Urinary Urgency Incontinence With Wireless Neuromodulation Technology (PROTECT)
Urinary Incontinence, Urge
About this trial
This is an interventional treatment trial for Urinary Incontinence, Urge focused on measuring Chronic Tibial nerve stimulation, Wireless PNS, neuromodulation
Eligibility 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.
Sites / Locations
- Tilda Research IncRecruiting
- Kaiser PermanenteRecruiting
- University of California Irvine Medical CenterRecruiting
- Westview Clinical ResearchRecruiting
- Advanced Urology InstituteRecruiting
- Baptist Health Miami Cancer Institute
- Florida Urology PartnersRecruiting
- William Beaumont HospitalRecruiting
- St. Louis Pain ConsultantsRecruiting
- Adult & Pediatric Urology, P.C.Recruiting
- Urology - Iris Cantor Men's Health CenterRecruiting
- Stony Brook University Medical CenterRecruiting
- Integrated Pain SpecialistsRecruiting
- University of Oklahoma health Sciences Center
- UT Southwestern Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
CAN-Stim Group - CAN-Stim System
SNS Group - Interstim® System
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.
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.