Recruiting

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

Sponsor:

Uro Medical Corporation

Code:

NCT02577302

Conditions

Urinary Incontinence, Urge

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CAN-Stim - Protect CAN-Stim System

SNS - InterStim® System

Study Details

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

Study ID

NCT02577302

Start date

Jun 21, 2018

Status verified date

Oct, 2023

Completion date

Oct, 2025

Anticipated

Primary completion date

Oct, 2025

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: CAN-Stim Group - CAN-Stim 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.

active comparator: SNS Group - Interstim® System

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.

Interventions

CAN-Stim - Protect CAN-Stim System

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.

SNS - InterStim® System

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.

Primary outcome measure

Response rate: a ≥ 50% reduction in number of urgency related incontinence episodes [ Time Frame: 3 Months ]
device- and procedure-related Adverse Events (AE) [ Time Frame: 3 Months ]

Central Contacts and Locations

Central contacts

Miriam Chery

888-691-0585 contact@micronmed.com

Shanice Saunders

888-691-0585 contact@micronmed.com

Locations

Tilda Research Inc

Recruiting

Laguna Hills, California, United States, 92653

Contacts

Justin Deck

949-680-3490 jdeck@tilda.bio

Principal Investigator:

Kenneth Deck, MD

Kaiser Permanente

Recruiting

Los Angeles, California, United States, 90027

Contacts

Isabel Gallegos

323-783-5081 Isabel.Gallegos@kp.org

Principal Investigator:

Christopher Tenggardjaja

University of California Irvine Medical Center

Recruiting

Orange, California, United States, 92868

Contacts

Phuong Linh Huynh, MPH

714-456-6155 plhuynh@uci.edu

Principal Investigator:

Felicia Lane, MD

Westview Clinical Research

Recruiting

Placentia, California, United States, 92870

Contacts

Uyen Kim Hoang

562-343-7181 uyenhoang@wcr8.com

Principal Investigator:

Albert Lai, MD

Advanced Urology Institute

Recruiting

Daytona Beach, Florida, United States, 32114

Contacts

Jonelle Horsley

386-239-8500 jonelle.horsley@auihealth.com

Jorge Rodriguez

386-239-8500 jorge.rodriguez@auihealth.com

Principal Investigator:

Matthew Merrell, MD

Florida Urology Partners

Recruiting

Tampa, Florida, United States, 33615

Contacts

Linda Seibert

239-223-4488 linda@gulfcoastcta.com

Principal Investigator:

Osvaldo Padron

William Beaumont Hospital

Recruiting

Royal Oak, Michigan, United States, 48073

Contacts

Amanda Schonhoff, RN

248-551-1225 Amanda.Schonhoff@beaumont.org

Angela Waldvogel, RN

(248) 551 2572 Angela.Waldvogel@beaumont.org

Principal Investigator:

Larry Sirls, MD

St. Louis Pain Consultants

Recruiting

Saint Louis, Missouri, United States, 63017

Contacts

Kermit Mclauchlin

kermet.mclauchlin@stl-pain.com

Kim Scally

314-315-9905 kimS@metrourology.net

Principal Investigator:

Anne Christopher, MD

Adult & Pediatric Urology, P.C.

Recruiting

Omaha, Nebraska, United States, 10707

Contacts

Amy Nelson

402-399-7892 Anelson@adultpediatricuro.com

Principal Investigator:

Rebecca McCrery, MD

Urology - Iris Cantor Men's Health Center

Recruiting

New York, New York, United States, 10065

Contacts

Ahra Cho

646-962-9395 ahc4001@med.cornell.edu

Principal Investigator:

Bilal Chughtai, MD

Stony Brook University Medical Center

Recruiting

Stony Brook, New York, United States, 11794

Contacts

Margaret Brand

631-813-0540 Margaret.brand@stonybrookmedicine.edu

Principal Investigator:

Jason Kim, MD

Integrated Pain Specialists

Recruiting

Columbus, Ohio, United States, 43240

Contacts

Melissa Simons

614-383-6450 msimons.ips@gmail.com

Rachel Garey

614-264-7070 rgarey@centralohiourology.com

Principal Investigator:

Gladstone McDowell, MD

UT Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

Allison Beaver

214-645-8787 Allison.Beaver@UTSouthwestern.edu

Principal Investigator:

Gary Lemack, MD

More Information

Sponsor

Uro Medical Corporation

Last update posted

Oct 4, 2023

Last verified

Oct, 2023

Keywords

Chronic Tibial nerve stimulation
Wireless PNS
neuromodulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Uro Medical Corporation on 2023-10-04.