CAN-Stim Compared to SNS in Treatment of Urinary Urgency Incontinence With Wireless Neuromodulation Technology

Status unconfirmed · Not applicable

Conditions studied: Urinary Incontinence, Urge

In brief

This is a prospective, randomized, controlled, multi-center, study in which 150 evaluable subjects will be randomized 1:1 to receive either a Protect CAN-Stim or SNS InterStim® system. Subjects from both groups will immediately start with therapy. The primary endpoint is a ≥ 50% reduction in number of incontinence episodes associated with urgency at the 3-month visit, with additional measurements assessed at 14 days, 1, 6, 9 and 12-months.

Key facts

Study ID

NCT02577302

Run by

Uro Medical Corporation

People needed

200

Starts

2018-06-21

Expected to finish

2025-10-01

Last updated by the study team

2023-10-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 it is running

• UT Southwestern Medical Center — Dallas, Texas, United States (enrolling)
• Kaiser Permanente — Los Angeles, California, United States (enrolling)
• University of California Irvine Medical Center — Orange, California, United States (enrolling)
• Westview Clinical Research — Placentia, California, United States (enrolling)
• Advanced Urology Institute — Daytona Beach, Florida, United States (enrolling)
• Integrated Pain Specialists — Columbus, Ohio, United States (enrolling)
• Tilda Research Inc — Laguna Hills, California, United States (enrolling)
• Florida Urology Partners — Tampa, Florida, United States (enrolling)
• William Beaumont Hospital — Royal Oak, Michigan, United States (enrolling)
• St. Louis Pain Consultants — St Louis, Missouri, United States (enrolling)
• Adult & Pediatric Urology, P.C. — Omaha, Nebraska, United States (enrolling)
• Urology - Iris Cantor Men's Health Center — New York, New York, United States (enrolling)
• Stony Brook University Medical Center — Stony Brook, New York, United States (enrolling)
• Baptist Health Miami Cancer Institute — Miami, Florida, United States
• University of Oklahoma health Sciences Center — Oklahoma City, Oklahoma, United States

Full record on ClinicalTrials.gov

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