Medtronic plc today announced the launch of its NURO System that delivers percutaneous tibial neuromodulation (PTNM) for the treatment of overactive bladder (OAB) with symptoms of urinary urgency, urinary frequency, and urge incontinence. PTNM, a minimally invasive, periodic, office-based procedure, provides a measurable reduction in urinary frequency and/or urinary incontinence episodes following treatment without the side effects of medication.1, 2
The number of OAB patients is staggering and increasing – more than 37 million Americans, or nearly 1 in 6 suffer – it is more common than diabetes or asthma.3, 4, 5, 6 While not life threatening, OAB significantly impacts quality of life, and can negatively affect social activities, exercise and cause disruptive nighttime voiding.7, 8 Many sufferers are frustrated and embarrassed and limit their lives socially, professionally, and personally.9 However, only 33 percent of those suffering seek treatment and as many as 7 in 10 stop using medications within 6 months due to intolerable side effects or unsatisfying results.10, 11
“Many people with OAB are unsatisfied with current treatments and a significant number are not seeking treatment altogether, ” said Dr. Harriette Scarpero, of Associated Urologists of Nashville, Tennessee. “With the NURO System, I can offer patients another option to restore bladder function and improve quality of life without the side effects of medication. This minimally invasive therapy targets the brain-bladder miscommunication and can help improve quality of life in a meaningful way.”
The NURO System delivers a gentle electrical pulse to the tibial nerve via an acupuncture-like needle placed in the skin near the ankle that is attached to a neurostimulator. The therapy is administered in physician offices during weekly 30-minute sessions for 12 weeks and thereafter as prescribed by a physician. Patients are free to read or listen to music while therapy is administered. The most common side effects are temporary and include mild pain or skin inflammation at or near the stimulation site.
Evidence points to OAB being caused by a miscommunication between the bladder and brain.12 Medtronic Bladder Control Therapies use neuromodulation, or gentle nerve stimulation, to reset the brain-bladder communication pathway. PTNM is thought to improve bladder function by targeting the tibial nerve, indirectly activating the central nervous system to help alleviate symptoms.
In clinical trials PTNM significantly decreased the number of incontinence episodes and voids per day, reduced the number of urgency and urge incontinence episodes and increased voiding volume.1, 14 With maintenance therapy, PTNM can offer long-term relief.15
“So many suffer from OAB and the majority are either not treated or not finding relief with other treatments, so Medtronic is pleased to offer another option along the care pathway, ” said Linnea Burman, vice president and general manager, gastro/urology therapies at Medtronic. “Our hope is that our expanding neuromodulation portfolio can help a broader range of patients get their lives back.”
Medtronic offers NURO patients the Support Link program that provides education, helps patients track their treatment and encourages compliance throughout therapy.
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2Peters, K. M., S. A. Macdiarmid, et al. (2009). “Randomized trial of percutaneous tibial nerve stimulation versus extended-release tolterodine: results from the overactive bladder innovative therapy trial.” J Urol 182(3): 1055-1061.
3Stewart WF, J.B. Van Rooyen, et al. (2003). “Prevalence and burden of overactive bladder in the United States.” World J Urol 20(6): 327-336.
4United Nations, Department of Economic and Social Affairs, Population Division (2011). World Population Prospects: The 2010 Revision, CD-ROM Edition.
5Adult self-reported lifetime asthma prevalence rate (percent) and prevalence (number) by state or territory: BRFSS 2010. Centers for Disease Control and Prevention website. http://www.cdc.gov/asthma/brfss/2010/lifetime/tableL1.htm. Updated August 27, 2012. Accessed January 25, 2016.
6National diabetes statistics report, 2014. National Diabetes Information Clearinghouse website.http://www.cdc.gov/diabetes/pubs/statsreport14/national-diabetes-report-web.pdf. Updated 2014. Accessed January 25, 2016.
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13Govier, F. E., S. Litwiller, et al. (2001). “Percutaneous afferent neuromodulation for the refractory overactive bladder: results of a multicenter study.” J Urol 165(4): 1193-1198.
14Peters, K.M., D.J. Carrico, et al. (2010). “Randomized trial of percutaneous tibial nerve stimulation versus Sham efficacy in the treatment of overactive bladder syndrome: results from the SUmiT trial.” J Urol 183(4):1438-1443.
15Peters, K.M., D.J. Carrico, et al. (2013). “Percutaneous tibial nerve stimulation for the long-term treatment of overactive bladder: 3-year results of the STEP study.” J Urol 189(6): 2194-2201.