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

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ClinicalTrials.gov Identifier: NCT02577302
Recruitment Status : Recruiting
First Posted : October 16, 2015
Last Update Posted : September 18, 2019
Sponsor:
Information provided by (Responsible Party):
StimGuard, LLC.

Tracking Information
First Submitted Date  ICMJE October 12, 2015
First Posted Date  ICMJE October 16, 2015
Last Update Posted Date September 18, 2019
Actual Study Start Date  ICMJE June 21, 2018
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 26, 2018)
  • 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
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 14, 2015)
  • Reduction in number of urge related incontinence episodes. [ Time Frame: 3 Month, 12 Month ]
    A ≥ 50% reduction in number of urgency related incontinence episodes at 3 months post-activation of the Protect CTNS system compared to 12-weekly in-office PTNS treatments
  • Incidence and severity of adverse events. [ Time Frame: 12 Month ]
Change History Complete list of historical versions of study NCT02577302 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 26, 2018)
  • 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.
  • 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.
  • 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;
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 14, 2015)
  • Patient preference to therapy via Usability Questionnaire [ Time Frame: 3 Month,12 Month ]
    The number of patients who prefer therapy via an implantable device or a transcutaneous treatment that requires office visits as reported by the questionnaire
  • Proportion of subjects with a reduction in number of voids compared to baseline. [ Time Frame: Baseline, 3 Month, 12 Month ]
  • Proportion of subjects with a reduction in the degree of urgency as measured by PPIUS. [ Time Frame: Baseline, 3 Month, 12 Month ]
  • Improved quality of life function via the Incontinence Quality of Life Scale (I-QOL) [ Time Frame: 3 Month, 12 Month ]
Current Other Pre-specified Outcome Measures
 (submitted: March 4, 2019)
  • 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
  • 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.
  • Episodes [ Time Frame: 3, 6,12 Months ]
    The number of episodes associated with urgency as illustrated by voiding diaries
  • 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
  • OAB [ Time Frame: 3, 6,12 Months ]
    Overactive Bladder Questionnaire Short Form (OAB-Q)
  • 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
Original Other Pre-specified Outcome Measures
 (submitted: October 14, 2015)
  • Proportion of subjects dry [ Time Frame: 3 Month, 12 Month ]
  • Number of Episodes associated with urge [ Time Frame: 3 Month, 12 Month ]
  • Proportion of subjects reporting moderately or markedly improved via the Global Response Assessment (GRA) [ Time Frame: 3 Month, 12 Month ]
  • Improved quality of life function via Overactive Bladder Questionnaire (OAB-Q) [ Time Frame: 3 Month, 12 Month ]
 
Descriptive Information
Brief Title  ICMJE CAN-Stim Compared to SNS in Treatment of Urinary Urgency Incontinence With Wireless Neuromodulation Technology
Official Title  ICMJE 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)
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Prospective, Randomized, Controlled, Non-Inferiority
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Urinary Incontinence, Urge
Intervention  ICMJE
  • Device: CAN-Stim - StimGuard Protect CAN-Stim System
    CAN-Stim subjects will be implanted unilaterally (implantation side is up to the investigators discretion) with the StimGuard 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.
  • 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.
Study Arms  ICMJE
  • Experimental: CAN-Stim Group-StimGuard 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.

    Intervention: Device: CAN-Stim - StimGuard Protect CAN-Stim System
  • 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.

    Intervention: Device: SNS - InterStim® System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 26, 2018)
200
Original Estimated Enrollment  ICMJE
 (submitted: October 14, 2015)
300
Estimated Study Completion Date  ICMJE October 2021
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Niek vanquathem 0032492692223 niek@freedomneuro.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02577302
Other Study ID Numbers  ICMJE 30-00137
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
Pediatric Postmarket Surveillance of a Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: upon study completion
Responsible Party StimGuard, LLC.
Study Sponsor  ICMJE StimGuard, LLC.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account StimGuard, LLC.
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP