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

Launched by URO MEDICAL CORPORATION · Oct 14, 2015

Keywords

ClinConnect Summary

This clinical trial is studying two different treatments for people with urinary urgency incontinence, a condition where individuals feel a sudden, strong urge to urinate and may have trouble controlling it. The trial is comparing a new device called the Protect CAN-Stim with the established InterStim® system. Up to 150 participants will be involved, and they will be randomly assigned to receive one of the two treatments right away. The main goal is to see if participants experience a significant reduction in the number of incontinence episodes within three months.

To be eligible for this trial, participants need to be at least 18 years old and have been diagnosed with urinary incontinence that is primarily caused by an overactive bladder. They should have experienced at least four episodes of incontinence related to urgency over a few days and tried other treatments without success. Participants will be monitored at various points during the trial, including at 14 days, 1 month, and 12 months after starting treatment, to assess improvements in their condition. It’s important to note that some individuals may not qualify due to certain health conditions or treatments they have received in the past.

Gender

ALL

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.