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Clinical Feasibility Study, Implantable Tibial Nerve Stimulator (ITNS)

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: NCT04115228
Recruitment Status : Recruiting
First Posted : October 3, 2019
Last Update Posted : October 23, 2019
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Nine Continents Medical, Inc.

Brief Summary:

Study objectives: To report feasibility data for safety and effectiveness of the study device.

Study device: Nine Continents Medical implantable tibial nerve stimulator (ITNS) model 9C-680 with programmer model 9C-580.

Intended use: The study device is intended for treatment of the symptoms of overactive bladder (OAB), including urinary urge incontinence and significant symptoms of urgency-frequency alone or in combination, in patients who have failed or could not tolerate more conservative treatments.

Type of design: Single-arm longitudinal design.

Study sites: Single site, in the United States.

Study duration: One year total, comprising six months for enrolling and implanting 10 subjects, and 26 weeks for follow-up.


Condition or disease Intervention/treatment Phase
Overactive Bladder Device: Implantation and neuromodulation therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Clinical Feasibility Study, Implantable Tibial Nerve Stimulator (ITNS)
Actual Study Start Date : October 9, 2019
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Study device
Subjects who provide informed consent, meet all inclusion criteria, and no exclusion criterion, will have a study device implanted and followed closely for 26 weeks.
Device: Implantation and neuromodulation therapy
The study device is an autonomous permanent implant for neuromodulation targeting the posterior tibial nerve. It does not require an external power source or charger.
Other Name: Nine Continents Medical ITNS model 9C-680




Primary Outcome Measures :
  1. Adverse events [ Time Frame: 26 weeks ]
    Incidence, severity, and relatedness of all adverse events and device deficiencies.

  2. Improvement from baseline of urgency urinary incontinence [ Time Frame: 13 weeks ]
    Percentage decrease in number of episodes in a 3-day diary

  3. Improvement from baseline of voiding frequency [ Time Frame: 13 weeks ]
    Percentage decrease in number of voids during waking hours exceeding 7 in a 3-day diary

  4. Improvement from baseline of nocturia [ Time Frame: 13 weeks ]
    Percentage decrease in number of voids awakening from sleep in a 3-day diary

  5. Improvement from baseline of voids with urgency [ Time Frame: 13 weeks ]
    Percentage decrease in number of voids self-reported with moderate to severe urgency


Secondary Outcome Measures :
  1. Threshold [ Time Frame: 13 weeks ]
    Stability of neuromodulation pulse amplitude required to evoke paresthesia or motor response ("threshold").

  2. Quality of life - symptom bother [ Time Frame: 13 weeks ]
    Improvement from baseline of: overactive bladder symptom and health-related quality of life questionnaire (OAB-q), short form symptom bother

  3. Quality of life - global [ Time Frame: 13 weeks ]
    Improvement from baseline of: global response assessment (GRA)



Information from the National Library of Medicine

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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:

At pre-screening:

  • Age 18 years or older;
  • Documented diagnosis of overactive bladder;
  • Documented failed behavioral intervention and/or physical therapy;
  • Documented failed first drug for overactive bladder; and
  • Documented failed second drug for overactive bladder.

At screening:

  • Life expectancy of at least one year;
  • Capable of tolerating the implantation procedure;
  • Ambulatory and able to use the toilet independently and without difficulty; and
  • Able to sense and tolerate posterior tibial nerve stimulation (transcutaneous test).

Based on pre-therapy voiding diary:

  • Average daily voids during waking hours ≥ 11;
  • Average daily voids interrupting sleep ≥ 2.0;
  • Average daily voids associated with urgency ≥ 4; or
  • Average daily incontinence episodes ≥ 1.

Exclusion Criteria:

At pre-screening:

  • Predominant stress incontinence;
  • For females, pelvic organ prolapse quantification (POP-Q) ≥ grade II;
  • Neurologic disease, e.g. MS, Parkinson's;
  • Abnormal upper urinary tract function;
  • Neurogenic bladder;
  • Bladder stone or tumor;
  • Body mass index (BMI) > 40;
  • Chronic pelvic pain;
  • Urinary fistula;
  • Peripheral neuropathy;
  • History of failed neuromodulation for overactive bladder;
  • Uncontrolled bleeding disorder;
  • End stage renal failure, glomerular filtration rate (GFR) < 35, or dialysis;
  • Untreated diabetes or A1C > 7;
  • Implanted pacemaker, defibrillator, or neurostimulator;
  • History of pelvic cancer within the past two years;
  • Condition requiring magnetic resonance imaging (MRI);
  • Condition requiring diathermy;
  • Metallic implant in planned site of study device;
  • For females, pregnant;
  • For females, planning to become pregnant;
  • For females, given birth in the last 6 months; or
  • For females, of child-bearing potential and not willing to practice a medically-approved method of birth control during the study.

At screening:

  • Anatomical restriction preventing device placement;
  • Skin lesions or compromised skin at the implant site;
  • For females, pelvic organ prolapse quantification (POP-Q) ≥ grade II;
  • Post-void residual > 150 cc;
  • Urinary tract mechanical obstruction due to urethral stricture;
  • Urinary tract mechanical obstruction due to bladder neck contracture;
  • In males, urinary tract mechanical obstruction due to benign prostatic hyperplasia (BPH);
  • Vesicoureteral reflux;
  • Cystoscopic abnormalities that could be malignant;
  • Current cystitis;
  • Current urethritis;
  • Gross hematuria;
  • In females, positive pregnancy test;
  • Any other medical condition with potential effect on bladder function, as assessed by investigator; or
  • Any other medical condition that could compromise the safety of the subject, as assessed by investigator.

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): NCT04115228


Contacts
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Contact: Peter Jacobson (612) 405-2892 peter@9cmed.com
Contact: Alan Ostroff (612) 405-2892 alan@9cmed.com

Locations
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United States, California
Pacific Urology Recruiting
San Ramon, California, United States, 94583
Contact: Parminder Sethi, M.D.         
Contact    (925) 830-1140      
Sponsors and Collaborators
Nine Continents Medical, Inc.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Parminder Sethi, M.D. Pacific Urology

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Responsible Party: Nine Continents Medical, Inc.
ClinicalTrials.gov Identifier: NCT04115228    
Other Study ID Numbers: ITNS-01
R44DK121578 ( U.S. NIH Grant/Contract )
First Posted: October 3, 2019    Key Record Dates
Last Update Posted: October 23, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms