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 life^1-5†
• 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 bother^9‡

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

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 weeks^1†, 1 year¹⁰, 2 years^11,12†, and 3 years^13† 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 weeks^1†, 1 year¹⁰, 2 year^11,12†, and 3 year^13† 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.