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

NCT02577302 | Unknown DMC FDA Device

• 1 other identifier: 30-00137
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 15

Brief Summary

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.

Conditions

Urinary Incontinence, Urge

Keywords

Chronic Tibial nerve stimulation; Wireless PNS; neuromodulation

Outcome Measures

Primary Outcomes (2)

• Response rate: a ≥ 50% reduction in number of urgency related incontinence episodes

  The primary efficacy endpoint is defined as a ≥ 50% reduction in number of urgency related incontinence episodes at 3 months post-implant of the CAN-Stim system compared to SNS InterStim® system therapy. The number of urgency incontinent episodes per day is taken as an average of two 3-day consecutive bladder diaries, with at least 24 hours between when the first diary ends and the second diary begins

  3 Months

• device- and procedure-related Adverse Events (AE)

  The safety endpoint is the device- and procedure-related Adverse Events (AE) rate at 3 months in the CAN-Stim and SNS groups.

  3 Months

Secondary Outcomes (4)

• Response rate: a ≥ 50% reduction in number of urgency related incontinence episodes

  6,12 Months

• device- and procedure-related Adverse Events (AE)

  6,12 Months

• Voiding Frequency

  3, 6,12 Months

• Reduction in degree of urgency

  3, 6,12 Months

Other Outcomes (6)

• Quality of Life: I-QOL: Quality of Life Scale (I-QOL)

  3, 6,12 Months

• Proportion of subjects dry

  3, 6,12 Months

• Episodes

  3, 6,12 Months

Study Arms (2)

CAN-Stim Group - CAN-Stim System

EXPERIMENTAL

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.

Device: CAN-Stim - Protect CAN-Stim System

SNS Group - Interstim® System

ACTIVE COMPARATOR

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.

Device: SNS - InterStim® System

Interventions

CAN-Stim - Protect CAN-Stim System DEVICE

CAN-Stim subjects will be implanted unilaterally (implantation side is up to the investigators discretion) with the CAN-Stim System. Subjects will be educated on the use of the transmitter and programmer. Therapy will be delivered for a minimum of 8 hours per day for 2 weeks. Subjects who are considered a responder at the 2-week follow-up, will continue therapy and followed for a total of 12 months.

CAN-Stim Group - CAN-Stim System

SNS - InterStim® System 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.Therapy will be delivered for a minimum of 8 hours per day for 2 weeks. Subjects who are considered a responder at the 2-week follow-up, will receive a full implant and followed for a total of 12 months.

SNS Group - Interstim® System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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;

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;

Sponsors & Collaborators

• Uro Medical Corporation: lead

Study Sites (15)

Tilda Research Inc

Laguna Hills, California, 92653, United States

RECRUITING

Kaiser Permanente

Los Angeles, California, 90027, United States

RECRUITING

University of California Irvine Medical Center

Orange, California, 92868, United States

RECRUITING

Westview Clinical Research

Placentia, California, 92870, United States

RECRUITING

Advanced Urology Institute

Daytona Beach, Florida, 32114, United States

RECRUITING

Baptist Health Miami Cancer Institute

Miami, Florida, 33176, United States

WITHDRAWN

Florida Urology Partners

Tampa, Florida, 33615, United States

RECRUITING

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

RECRUITING

St. Louis Pain Consultants

St Louis, Missouri, 63017, United States

RECRUITING

Adult & Pediatric Urology, P.C.

Omaha, Nebraska, 10707, United States

RECRUITING

Urology - Iris Cantor Men's Health Center

New York, New York, 10065, United States

RECRUITING

Stony Brook University Medical Center

Stony Brook, New York, 11794, United States

RECRUITING

Integrated Pain Specialists

Columbus, Ohio, 43240, United States

RECRUITING

University of Oklahoma health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

ACTIVE NOT RECRUITING

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence, Urge

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Miriam Chery

CONTACT

888-691-0585; contact@micronmed.com

Shanice Saunders

CONTACT

888-691-0585; contact@micronmed.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, Randomized, Controlled, Non-Inferiority

Study Record Dates

• First Submitted: October 12, 2015
• First Posted: October 16, 2015
• Study Start: June 21, 2018
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: October 4, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share

Locations

US (15)