An Injectable Electrode to Better Isolate the Posterior Tibial Nerve to Treat OAB

Abstract Urinary urgency, with or without incontinence, greatly affects the quality of life in individuals suffering from Overactive Bladder (OAB). A sudden and often overwhelming desire to pass urine occurs frequently (8 times and more) throughout the day, often coinciding with nocturia. More prevalent in females, the overall prevalence in U.S. studies is 14%. Lifestyle modifications, bladder retraining, pelvic floor exercise and antimuscarinic OAB therapies are initial treatments for OAB. Although these can provide some relief, complete relief is rare, and treatment is entirely unsuccessful in 25-40% of women (refractory OAB) due to lack of initial effect, developed tolerance, or intolerable side effects leading to discontinuation. Both implantable and non-invasive posterior tibial nerve stimulation (PTNS) devices have been FDA approved to treat refractory OAB. These existing PTNS devices are placed many millimeters or even centimeters from the nerve, and have significant issues with inconsistent targeting/migration, with stimulation induced side-effects putatively limiting engagement with intended A-beta sensory fibers within the tibial nerve. Implantable PTNS devices are also costly and complex, leading to significant device related complications. To address these issues, we will use a rational engineering approach to develop, validate and optimize a novel minimally invasive electrode strategy consisting of only 2 implanted passive materials, and an associated surgical tool that allows for direct targeting of the nerve via injection. We anticipate this will yield dramatically improved nerve engagement while reducing complications.