Clinical Feasibility Study, Implantable Tibial Nerve Stimulator (ITNS)

Clinical Feasibility Study, Implantable Tibial Nerve Stimulator (ITNS)

Sponsors

Lead sponsor: Nine Continents Medical, Inc.

Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Source 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.

Overall Status Recruiting
Start Date October 9, 2019
Completion Date December 31, 2020
Primary Completion Date September 30, 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Adverse events 26 weeks
Improvement from baseline of urgency urinary incontinence 13 weeks
Improvement from baseline of voiding frequency 13 weeks
Improvement from baseline of nocturia 13 weeks
Improvement from baseline of voids with urgency 13 weeks
Secondary Outcome
Measure Time Frame
Threshold 13 weeks
Quality of life - symptom bother 13 weeks
Quality of life - global 13 weeks
Enrollment 10
Condition
Intervention

Intervention type: Device

Intervention name: Implantation and neuromodulation therapy

Description: 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.

Arm group label: Study device

Other name: Nine Continents Medical ITNS model 9C-680

Eligibility

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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Parminder Sethi, M.D. Principal Investigator Pacific Urology
Overall Contact

Last name: Peter Jacobson

Phone: (612) 405-2892

Email: [email protected]

Location
facility status contact contact_backup Pacific Urology Parminder Sethi, M.D.
Location Countries

United States

Verification Date

October 2019

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Arm group label: Study device

Arm group type: Experimental

Description: 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.

Patient Data No
Study Design Info

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Device Feasibility

Masking: None (Open Label)

Source: ClinicalTrials.gov