CLINICAL DATA Percutaneous Tibial Neuromodulation (PTNM)
Percutaneous Tibial Neuromodulation (PTNM), delivered by the Medtronic NURO™ system, is a safe, minimally-invasive, and effective OAB treatment option to restore* bladder function and improve quality of life.
While the NURO device was not used in the studies described below, since it delivers equivalent stimulation therapy as the device used in the studies, a user can expect similar performance.
In a study by Peters and Carrico (2013), Percutaneous Tibial Nerve Stimulation (PTNS), otherwise known as PTNM, was determined to be an effective OAB treatment in both men and women, regardless of age and prior use of OAB medications. Twelve weekly PTNM treatments are needed to realize the full treatment efficacy for those suffering with OAB.1
The safety of PTNM has been reported on extensively in the literature. For example, Peters et al. (2009) reported on a randomized, multicenter, controlled study that compared the effectiveness of PTNM to extended-release tolterodine.
This trial demonstrates that PTNM is safe with statistically significant improvements in patient assessment of overactive bladder symptoms, and with objective effectiveness of PTNM comparable to that of pharmacotherapy.2
Additionally, the safety of PTNM has been demonstrated in many clinical studies at time points of 12 weeks3, 1 year4, 2 years5,6, and 3 years7 of clinical use. Specifically, a study by Peters et al. (2013) concluded that most STEP participants with an initial positive response to 12 weekly PTNM treatments safely sustained overactive bladder symptom improvement to 3 years with an average of 1 treatment per month.7 Another study by Martinson et al. (2013) concluded that PTNM is a safe neuromodulation therapy for overactive bladder.8
The effectiveness of PTNM has been studied at 12 weeks, 1 year, 2 year and 3 year intervals. A pivotal multicenter, double-blind, randomized, sham-controlled trial concluded that PTNM therapy is effective in treating overactive bladder symptoms after 12 weeks of treatment.3
Following patients out to two years showed continued success with PTNM treatment. Peters et al. (2013) concluded that sustained efficacy of PTNM was demonstrated over 24 months with initial success after 12 weekly treatments, followed by a 14-week prescribed tapering protocol and a Personalized Treatment Plan. With an average of 1.3 treatments per month, PTNM therapy is a safe and durable long-term OAB treatment option to sustain clinically significant OAB symptom control.5 Another two year study concluded that women receiving PTNM for intractable OAB syndrome reported significant symptom relief at 2 years and that PTNM is a safe and durable mode of treatment.6 Finally, PTNM has been shown to be effective for sustained overactive bladder symptom improvement to 3 years with an average of 1 treatment per month.7
Most common side effects are temporary and include mild pain or skin inflammation at or near the stimulation site.
Restored bladder function is defined as a measurable reduction in urinary frequency and/or urinary incontinence episodes following treatment.
Peters, K., Carrico, D., Clinical Insights into Percutaneous Tibial Nerve Stimulation (PTNS) versus Sham Therapy for the Treatment of Overactive Bladder Syndrome (OAB): Secondary Analysis of the SUmiT Trial. 2013. Poster presentation, SUFU winter meeting, Las Vegas, NV
Peters, K. M., MacDiarmid, S.A., et al., Randomized trial of percutaneous tibial nerve stimulation versus extended-release tolterodine: results from the overactive bladder innovative therapy trial. J Urol. 2009. 182(3): 1055-1061
Peters, K. M., Carrico, D.J., et al., Randomized trial of percutaneous tibial nerve stimulation versus Sham efficacy in the treatment of overactive bladder syndrome: results from the SUmiT trial. J Urol. 2010. 183(4):1438-1443
MacDiarmid, S.A., Peters, K.M., et al., Long-term durability of percutaneous tibial nerve stimulation for the treatment of overactive bladder. J Urol. 2010. 183(1): 234-240
Peters, K. M., Carrico, D.J., et al., Sustained therapeutic effects of percutaneous tibial nerve stimulation: 24-month results of the STEP study. Neurourol Urodyn. 2013. 32(1): 24-29
Yoong, W., Shah, P., et al., Sustained effectiveness of percutaneous tibial nerve stimulation for overactive bladder syndrome: 2-year follow-up of positive responders. Int Urogynecol J. 2013. 24(5): 795-799
Peters, K. M., Carrico, D.J., et al., Percutaneous tibial nerve stimulation for the long-term treatment of overactive bladder: 3-year results of the STEP study. J Urol. 2013. 189(6): 2194-2201
Martinson, M., MacDiarmid, S., et al., Cost of neuromodulation therapies for overactive bladder: percutaneous tibial nerve stimulation versus sacral nerve stimulation. J Urol. 2013. 189(1): 210-216