CLINICAL DATA Percutaneous Tibial Neuromodulation (PTNM)

A Safe Option to Restore Bladder Function*

Percutaneous Tibial Neuromodulation (PTNM), delivered by the Medtronic NURO™ system, is a safe, minimally-invasive, and effective overactive bladder (OAB) treatment option to restore* bladder function and improve quality of life.1

In 2018, the RESET study was the first to establish clinical evidence for the NURO system, determining that PTNM delivered by the NURO device can significantly reduce urge incontinence (UI) episodes for drug-naïve OAB patients.2 Prior to RESET, many published studies provided evidence supporting the safety and efficacy of PTNM for OAB patients, delivered by a different (but equivalent) device than NURO.3,4,5

RESET STUDY highlights

RESET is the first study to establish clinical evidence for the NURO device and is also the first to study the effects of NURO on patients who had not attempted medical management for OAB. In the study, 120 patients with OAB received 12 weekly PTNM sessions delivered by the NURO system.2 The treatment was assessed using voiding diaries, quality of life and other patient reported outcomes, and safety measures.RESET results established the safety and efficacy of PTNM using NURO.

Strong Patient-Reported Outcomes:

  • ~90% reduction in the proportion of patients who reported having severe or very severe problems with their overactive bladder (OAB), as evaluated by the Patient Perception of Bladder Condition (PPBC) scale7

Patient Symptom Reduction:

  • ~70% reduction in UUI episodes per day at completion of 12 PTNM sessions2

Quality of Life Improvement:

  • Significant Quality of Life improvements in total health-related quality of life and its subscales — including concern, coping, sleep and social — as well as symptom bother1†

    FINISH THE THERAPY FOR OPTIMAL RESULTS

    Results showed a trend of continued improvement in symptom relief, quality of life, and patient reported outcomes as patients completed more NURO sessions, and they had the best results when finishing the 12-session therapy.1,2,7

    pdf RESET Clinical Summary (.pdf)

    Download a two-page summary of outcomes from the RESET study.

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    PTNM Safety

    The safety of PTNM has been well-established in the literature prior to the RESET study. While the NURO device was not used in the studies described below, since it delivers equivalent stimulation therapy as the device used, a user can expect similar performance. For example, Peters et al. (2009) reported on a randomized, multicenter, controlled study that compared the effectiveness of PTNM to extended-release tolterodine.4

    Additionally, the safety of PTNM has been demonstrated in many clinical studies at time points of 12 weeks3, 1 year8, 2 years9,10, and 3 years5 of clinical use. A study by Peters et al (2013) demonstrated the safety of PTNM over 3 years of therapy with an average of 1 treatment per month after the initial 12 weeks of treatment.5

    Effectiveness of PTNM Therapy

    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.11

    The effectiveness of PTNM has been studied at 12 weeks3, 1 year8, 2 years9,10, and 3 yearsintervals. 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 Completing a full 12-session course of therapy is recommended for best results. 11

    Following patients out to two years showed continued success with PTNM treatment. Patients who had initial success after 12 weekly treatments underwent a 14-week tapering protocol and a Personalized Treatment Plan, with an average of 1.3 treatments per month. The authors concluded that PTNM efficacy was sustained over 24 months in these patients and that PTNM therapy is a safe and durable long-term option for clinically significant OAB symptom control.9

    In another two-year study of PTNM, women with intractable OAB reported significant relief of symptoms at 2 years and the authors concluded that PTNM is a safe and durable mode of treatment.10 Finally, in most patients who responded to the initial 12 weeks of PTNM, OAB symptom improvement was sustained to 3 years with an average of 1 treatment per month.5

    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.

    Evaluated using the Overactive Bladder Symptom Quality of Life Questionnaire (OAB-q).

    1

    Kobashi K, Margolis E, Sand P, et al. Prospective Study to Evaluate Quality of Life with Percutaneous Tibial Neuromodulation in Drug-Naïve Patients with Overactive Bladder Syndrome. Presented at the 2018 Annual Meeting of the International Continence Society.

    2

    Kobashi K, Khandwala S, MacDiarmid S, et al. A Prospective Study to Evaluate Efficacy with the NURO Percutaneous Tibial Neuromodulation System in Drug Naïve Patients with overactive bladder syndrome (OAB). Presented at the American Urological Association 2018 Annual Meeting. Journal of Urology. 2018;199(4) Supplement, Page e987.

    3

    Peters, KM, Carrico, DJ, Perez-Marrero, RA et al. Randomized Trial of Percutaneous Tibial Nerve Stimulation Versus Sham Efficacy in the Treatment of Overactive Bladder Syndrome: Results From the SUmiT Trial. The Journal of Urology. 2010;183:1438-1443.

    4

    Peters, KM, MacDiarmid, SA, Wooldridge, LS et al. Randomized Trial of Percutaneous Tibial Nerve Stimulation Versus Extended-Release Tolterodine: Results From the Overactive Bladder Innovative Therapy Trial. The Journal of Urology. 2009;182(3):1055-1061.

    5

    Peters, KM, Carrico, DJ, Wooldridge LS et al. Percutaneous Tibial Nerve Stimulation for the Long-Term Treatment of Overactive Bladder: 3-Year Results of the STEP Study. The Journal of Urology. 2013;189:2194-2201.

    6

    ClinicalTrials.gov NCT02857816

    7

    Sand P, Kobashi K, Margolis E, et al. Patient Reported Outcomes with Percutaneous Tibial Neuromodulation (PTNM) therapy in Drug Naïve Patients with Overactive Bladder (OAB) Syndrome. Presented at the American Urogynecologic Society 2018 Annual Scientific Meeting.

    8

    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

    9

    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): 24-2

    10

    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

    11

    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