Clinical Feasibility Study, Implantable Tibial Nerve Stimulator (ITNS)

Clinical Feasibility Study, Implantable Tibial Nerve Stimulator (ITNS)

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.

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.