RECRUITING

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

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Conditions

Urinary Incontinence, UrgeChronic Tibial nerve stimulationWireless PNSneuromodulation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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)

Quick Facts

Study Start:2018-06-21
Study Completion:2025-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02577302

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosis of overactive bladder with urgency urinary incontinence or mixed incontinence (urge and stress) with predominate urge, as confirmed by the MESA questionnaire;
  2. * Women and men ≥ 18 years of age;
  3. * Women of child-bearing age willing to practice birth control;
  4. * At least 4 incontinent episodes associated with urgency on a 3-day voiding diary;
  5. * At least 10 voids per day;
  6. * Average urgency score of at least 2 as measured with IUSS on a 3-day voiding diary;
  7. * Self-reported bladder symptoms present \> 6 months;
  8. * Documented failure of an adequate trial of first and second line therapy;
  9. * Off all antimuscarinics and beta-3 adrenergic agonists for at least 2 weeks prior to enrollment;
  10. * If on Tricyclic antidepressants, dosage must be stabilized for at least 3 months;
  11. * Have no active urethral obstruction/stricture, bladder calculi or bladder tumor based on medical history;
  12. * Normal upper urinary tract function based on medical history;
  13. * 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;
  14. * 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;
  15. * Based on the medical opinion of the Investigator, subject is a good surgical subject for the implant procedure;
  16. * Capable of giving informed consent;
  17. * Capable and willing to follow all study related procedures.
  1. * An active implantable electronic device regardless of whether stimulation is ON or OFF;
  2. * Pregnant as confirmed by a urine pregnancy test or plan to become pregnant during the following 12 months period;
  3. * Primary complaint of stress urinary incontinence;
  4. * Less than 1 year post-partum and/or are breast-feeding;
  5. * Neurogenic bladder (i.e. Multiple sclerosis, Parkinson's, Spinal Cord Injury);
  6. * Patients with spinal hardware that would limit access to the sacrum;
  7. * Botox use in bladder or pelvic floor muscles in the past nine months;
  8. * Have a post-void residual urine volume \>150 cc at baseline;
  9. * Current urinary tract infection (UTI);
  10. * Previous treatment with sacral neuromodulation;
  11. * Previous treatment with percutaneous tibial nerve stimulation, pelvic floor muscle stimulation, or biofeedback within the past 60 days;
  12. * Conditions requiring Magnetic Resonance Imaging (MRI) evaluation or diathermy procedures;
  13. * Inability to operate the CAN-Stim System or InterStim System;
  14. * Diabetes with peripheral nerve compromise or severe uncontrolled diabetes (HbA1C 8.5 or greater);
  15. * History of coagulopathy or bleeding disorder;
  16. * History of pelvic pain as primary diagnosis (VAS score of \> 4) at baseline;
  17. * Anatomical restrictions such that device placement is not possible;
  18. * Are currently participating or have participated within the past 30 days in any clinical investigation involving or impacting urinary or renal function;
  19. * Have a life expectancy of less than 1 year;
  20. * Cannot independently comprehend and complete the questionnaires and diaries;
  21. * Deemed unsuitable for enrollment by the investigator based on history or physical examination (including bleeding disorders or anticoagulant medications, and peripheral neuropathy);
  22. * Dependent on wearable, transcutaneous, or other therapeutic medical device (examples: glucose monitor, TENS) for treatment of a disease or disorder.

Contacts and Locations

Study Contact

Miriam Chery
CONTACT
888-691-0585
contact@micronmed.com
Shanice Saunders
CONTACT
888-691-0585
contact@micronmed.com

Study Locations (Sites)

Tilda Research Inc
Laguna Hills, California, 92653
United States
Kaiser Permanente
Los Angeles, California, 90027
United States
University of California Irvine Medical Center
Orange, California, 92868
United States
Westview Clinical Research
Placentia, California, 92870
United States
Advanced Urology Institute
Daytona Beach, Florida, 32114
United States
Baptist Health Miami Cancer Institute
Miami, Florida, 33176
United States
Florida Urology Partners
Tampa, Florida, 33615
United States
William Beaumont Hospital
Royal Oak, Michigan, 48073
United States
St. Louis Pain Consultants
Saint Louis, Missouri, 63017
United States
Adult & Pediatric Urology, P.C.
Omaha, Nebraska, 10707
United States
Urology - Iris Cantor Men's Health Center
New York, New York, 10065
United States
Stony Brook University Medical Center
Stony Brook, New York, 11794
United States
Integrated Pain Specialists
Columbus, Ohio, 43240
United States
University of Oklahoma health Sciences Center
Oklahoma City, Oklahoma, 73104
United States
UT Southwestern Medical Center
Dallas, Texas, 75390
United States

Collaborators and Investigators

Sponsor: Uro Medical Corporation

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-06-21
Study Completion Date2025-10

Study Record Updates

Study Start Date2018-06-21
Study Completion Date2025-10

Terms related to this study

Keywords Provided by Researchers

  • Chronic Tibial nerve stimulation
  • Wireless PNS
  • neuromodulation

Additional Relevant MeSH Terms

  • Urinary Incontinence, Urge