Overactive bladder (OAB), which afflicts one in six women worldwide, is a clear example of a neurosensory condition in need of a convenient bioelectronic alternative to pharmaceuticals. OAB is a symptom complex that can include urinary urgency, frequency, and incontinence. The definitive diagnosis and treatment guidelines for physicians from the American Urological Association (AUA)/Society of Urodynamics (SUFU) and endorsed by the American Urogynecologic Society (AUGS), are linked here.
The AUA/SUFU guidelines distinguish 1st-line behavioral therapies, 2nd-line pharmacologic management, and 3rd-line neuromodulation. While 1st-line therapy includes “electrical stimulation”, in practice most patients forgo or discontinue currently available transvaginal pelvic floor stimulators, given the inconvenience of using a daily hand-held probe and the uncertain benefit of intermittent stimulation. The vast majority of OAB treatment is based on pharmacologic management, with an estimated 9 million prescriptions written annually. By contrast, far less than 1% of patients cumulatively have benefited from the proven safety and efficacy of 3rd line sacral neuromodulation, FDA cleared since 1997, due to the inherent limitations of surgical invasiveness, expense, and need for specialist care.
OAB medications fall into the two classes of anticholinergics and β3- adrenoreceptor agonists. While some patients respond to these medications, unfortunately up to 70% discontinue them within 6 months, due to side-effects (ranging from constipation to dementia) and/or limited efficacy. Patient drop-off from their second medication is similarly significant. By contrast, studies show 90% of patients reporting a satisfactory reduction in symptoms from implanted sacral neuromodulation.
FemPulse wearable therapy is designed to afford women a significantly more patient-friendly neuromodulation option, with the goal of increasing adoption of treatment among the millions of untreated and undertreated women suffering with OAB. Research presented at the Society of Urodynamics (SUFU) February 2021 meeting confirmed that OAB sufferers prefer to trial a wearable OAB treatment more than any other option, including behavioral modification, physical therapy, medication, and all other forms of neuromodulation.
