clinical feasibility study, implantable tibial nerve stimulator (itns)

Conditions: Overactive Bladder

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.


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.