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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02577302
Recruitment Status : Recruiting
First Posted : October 16, 2015
Last Update Posted : March 23, 2020
Sponsor:
Information provided by (Responsible Party):
Micron Medical Corporation

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.

Condition or disease Intervention/treatment Phase
Urinary Incontinence, Urge Device: CAN-Stim - Protect CAN-Stim System Device: SNS - InterStim® System Not Applicable

Detailed Description:

Subjects will be randomized at baseline to either CAN-Stim or SNS InterStim® after inclusion and exclusion criteria have been met, 150 subjects will be randomized in to either arm of the study (89 subjects each arm).

At the following visit, CAN-Stim subjects will be immediately implanted unilaterally with a permanent device (implantation side up to investigators discretion). During implantation, the subject should feel pulsation in their foot with or without toe flexion, confirming stimulation of the tibial nerve. Subjects not achieving this motor response will not have the device implanted and will be exited from the study. Implanted subjects will be educated on the use of the transmitter and programmer. Programming parameters will be set and therapy will be delivered for a minimum of 8 hours per day for 2 weeks. Programming changes can be done as needed during this time period to maximize clinical response. At the 2-week visit, diaries will be reviewed and confirmed for accuracy and discrepancies and the number of urgency incontinence episodes will be calculated and compared to baseline diaries. Subjects who are considered a responder at the 2-week follow-up visit (>50% improvement in urgency related incontinence episodes) will continue therapy and followed for a total of 12 months with primary outcomes assessed at 3 months. Non-responders will be offered an explant of the device and will exit the study. Subjects having less than 50% improvement may choose to keep the device. These subjects will be followed for adverse events with phone calls at 3, 6 and 12 months.

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. Subjects, who respond intraoperatively, will have the extension lead connected and externalized in the standard fashion. Subjects may have their InterStim® activated 24 hours/day, but a minimum of 8 hours per day for 2 weeks is required to remain in the study. Programming changes can be done as needed during this time period to maximize the clinical effect. At the 2-week visit, diaries will be reviewed and confirmed for accuracy and clarified for discrepancies and the number of urgency incontinence episodes will be calculated and compared to baseline diaries. Patients achieving a clinical response (>50% improvement in urgency related incontinence episodes) will undergo implantation of a pulse generator and removal of the percutaneous extension lead. The IPG will be programmed in the standard fashion using settings that were working for the patient during the 2-week trial. Subjects implanted with the InterStim® device will be monitored for a total of 12 months with primary outcomes assessed at 3 months. Non-responders will be offered an explant of the device and will exit the study. Subjects having less than 50% improvement may choose to keep the device. These subjects will be followed for adverse events with phone calls at 3, 6 and 12 months.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, Randomized, Controlled, Non-Inferiority
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : June 21, 2018
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2021

Arm Intervention/treatment
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.

Device: 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.

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.

Device: 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 Measures :
  1. Response rate: a ≥ 50% reduction in number of urgency related incontinence episodes [ Time Frame: 3 Months ]
    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

  2. device- and procedure-related Adverse Events (AE) [ Time Frame: 3 Months ]
    The safety endpoint is the device- and procedure-related Adverse Events (AE) rate at 3 months in the CAN-Stim and SNS groups.


Secondary Outcome Measures :
  1. Response rate: a ≥ 50% reduction in number of urgency related incontinence episodes [ Time Frame: 6,12 Months ]
    The endpoint is defined as a ≥ 50% reduction in number of urgency related incontinence episodes at 6 and 12 months post-implant of the CAN-Stim system compared to SNS InterStim® system therapy. The number of urgency incontinent episodes per day is collected with a voiding diary.

  2. device- and procedure-related Adverse Events (AE) [ Time Frame: 6,12 Months ]
    The safety endpoint is the device- and procedure-related Adverse Events (AE) rate at 6 and 12 months in the CAN-Stim and SNS groups.

  3. Voiding Frequency [ Time Frame: 3, 6,12 Months ]
    The achievement in each subject of a ≥ 50% reduction in the number of voids or a return to normal voiding frequency (< 8 voids/day) from baseline to 3-, 6-, and 12-month follow-up in the CAN-stim group compared to the InterStim® group;

  4. Reduction in degree of urgency [ Time Frame: 3, 6,12 Months ]
    A reduction in the degree of urgency as measured with the Indevus Urgency Severity Scale (IUSS) in the CAN-Stim group compared to the InterStim® group.


Other Outcome Measures:
  1. Quality of Life: I-QOL: Quality of Life Scale (I-QOL) [ Time Frame: 3, 6,12 Months ]
    Change in the Urinary Incontinence Quality of Life Scale (I-QOL) in the CAN-Stim group compared to the InterStim® group

  2. Proportion of subjects dry [ Time Frame: 3, 6,12 Months ]
    B. The proportion of subjects dry as measured by the number of incontinence episodes per day associated with urgency as captured on the voiding diary.

  3. Episodes [ Time Frame: 3, 6,12 Months ]
    The number of episodes associated with urgency as illustrated by voiding diaries

  4. Improvement [ Time Frame: 3, 6,12 Months ]
    Global Response Assessment (GRA) will be used to compare the proportion of subjects reporting "moderately" or "markedly improved" responses on all subject visits

  5. OAB [ Time Frame: 3, 6,12 Months ]
    Overactive Bladder Questionnaire Short Form (OAB-Q)

  6. AE's [ Time Frame: 6, 12 months ]
    Adverse events both related or unrelated in the CAN-Stim group compared to the InterStim® group throughout the study



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02577302


Contacts
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Contact: Miriam Chery 888-691-0585 info@micronmed.com
Contact: Novell McGloster 888-691-0585 novell@micronmed.com

Locations
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United States, California
Tilda Research Inc Recruiting
Laguna Hills, California, United States, 92653
Contact: Justin Deck    949-680-3490    jdeck@tilda.bio   
Principal Investigator: Kenneth Deck, MD         
Sub-Investigator: Jennifer Gruenenfelder, MD         
Kaiser Permanente Recruiting
Los Angeles, California, United States, 90027
Contact: 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
Contact: Phuong Linh Huynh, MPH    714-456-6155    plhuynh@uci.edu   
Principal Investigator: Felicia Lane, MD         
Westview Clinical Research Recruiting
Placentia, California, United States, 92870
Contact: Uyen Kim Hoang    562-343-7181    uyenhoang@wcr8.com   
Principal Investigator: Albert Lai, MD         
Sub-Investigator: Michael Gazzaniga, MD         
United States, Florida
Baptist Health Miami Cancer Institute Recruiting
Miami, Florida, United States, 33176
Contact: Nicole Armand    786-594-7641    nicolearm@baptisthealth.net   
Principal Investigator: Christopher Gomez, MD         
Florida Urology Partners Recruiting
Tampa, Florida, United States, 33615
Contact: Linda Seibert    239-223-4488    linda@gulfcoastcta.com   
Principal Investigator: Osvaldo Padron         
United States, Michigan
William Beaumont Hospital Recruiting
Royal Oak, Michigan, United States, 48073
Contact: Amanda Schonhoff, RN    248-551-1225    Amanda.Schonhoff@beaumont.org   
Contact: Angela Waldvogel, RN    (248) 551 2572    Angela.Waldvogel@beaumont.org   
Principal Investigator: Larry Sirls, MD         
Sub-Investigator: Kenneth Peters, MD         
Sub-Investigator: Jason Gilleran, MD         
United States, Missouri
St. Louis Pain Consultants Recruiting
Saint Louis, Missouri, United States, 63017
Contact: Kermit Mclauchlin       kermet.mclauchlin@stl-pain.com   
Contact: Kim Scally    314-315-9905    kimS@metrourology.net   
Principal Investigator: Anne Christopher, MD         
Sub-Investigator: Cathy Naughton, MD         
United States, Nebraska
Adult & Pediatric Urology, P.C. Recruiting
Omaha, Nebraska, United States, 10707
Contact: Amy Nelson    402-399-7892    Anelson@adultpediatricuro.com   
Principal Investigator: Rebecca McCrery, MD         
United States, New York
Urology - Iris Cantor Men's Health Center Recruiting
New York, New York, United States, 10065
Contact: 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
Contact: Margaret Brand    631-813-0540    Margaret.brand@stonybrookmedicine.edu   
Principal Investigator: Jason Kim, MD         
United States, Ohio
Integrated Pain Specialists Recruiting
Columbus, Ohio, United States, 43240
Contact: Melissa Simons    614-383-6450 ext 5    msimons.ips@gmail.com   
Principal Investigator: Gladstone McDowell, MD         
United States, Oklahoma
University of Oklahoma health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Felicia Kiplinger    405-271-6900    Felicia-kiplinger@ouhsc.edu   
Principal Investigator: Gennady Slobodov, MD         
United States, Texas
UT Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Allison Beaver    214-645-8787    Allison.Beaver@UTSouthwestern.edu   
Principal Investigator: Gary Lemack, MD         
Sponsors and Collaborators
Micron Medical Corporation
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Responsible Party: Micron Medical Corporation
ClinicalTrials.gov Identifier: NCT02577302    
Other Study ID Numbers: 30-00137
First Posted: October 16, 2015    Key Record Dates
Last Update Posted: March 23, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: upon study completion

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Micron Medical Corporation:
Chronic Tibial nerve stimulation
Wireless PNS
neuromodulation
Additional relevant MeSH terms:
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Urinary Incontinence
Urinary Incontinence, Urge
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms