CLINICAL DATA PTNM IN SENIOR LIVING FACILITIES

Clinically proven to restore* bladder function

Percutaneous tibial neuromodulation (PTNM), delivered by the NURO™ system, is a safe and effective treatment option for urinary incontinence that offers residents the potential for:

  • Significantly improved quality of life1-5†
  • Superior reduction in urgency, frequency, and incontinence compared to sham2
  • Long-term relief with periodic therapy sessions and maintenance therapy6
  • Improvements in urinary symptoms that might help reduce the risk of falling7

HIGHLIGHTS FROM THE RESET STUDY

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.6 The treatment was assessed using voiding diaries, quality of life and other patient reported outcomes, and safety measures.7

RESET results established the safety and efficacy of PTNM using NURO:

  • ~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) scale8
  • ~70% reduction in UUI episodes per day at completion of 12 PTNM sessions6
  • 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 bother9‡

FINISH THE THERAPY FOR BEST 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.6,8,9

pdf RESET Clinical Summary (.pdf)

Summary of evidence from the RESET study on PTNM delivered by the NURO system.

104KB

SAFETY OF PTNM THERAPY

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 weeks1†, 1 year10, 2 years11,12†, and 3 years13† 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.13†


PTNM EFFECTIVENESS

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.14†

The effectiveness of PTNM has been studied at 12 weeks1†, 1 year10, 2 year11,12†, and 3 year13† 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.1 Completing a full 12-session course of therapy is recommended for best results.14†

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.11†


SIDE EFFECTS

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.

While the NURO device was not used in the Peters study cited here, since it delivers equivalent stimulation therapy as the device used in the study, a user can expect similar performance.

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

1

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.

2

Finazzi-Agrò E, Campagna A, Sciobica F, et al. Posterior tibial nerve stimulation: is the once-a-week protocol the best option? Minerva Urol Nefrol. 2005;57(2):119-123.

3

Govier FE, Litwiller S, Nitti V, et al. Percutaneous afferent neuromodulation for the refractory overactive bladder: results of a multicenter study. J Urol. 2001;165(4):1193-1198.

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

Leng WW, Morrisroe SN. Sacral nerve stimulation for the overactive bladder. Urol Clin N Am. 2006;33:491-501.

6

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.

7

ClinicalTrials.gov NCT02857816

8

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.

9

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.

10

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

11

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

12

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

13

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.

14

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