CLINICAL DATA PTNM IN SENIOR LIVING FACILITIES

Clinically proven to restore* bladder function

Percutaneous tibial neuromodulation (PTNM), delivered by the NUROTM system, is a safe and effective overactive bladder (OAB) treatment option 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

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.

Highlights from the SUmiT Study2

  • PTNM vs. Sham
  • 220 patients
  • Superior reduction in urgency, frequency, and incontinence episodes vs. sham
  • 5% of patients had mild/moderate PTNM-related adverse events

Highlights from the OrBIT Study1

  • PTNM vs. Medications
  • 100 patients
  • 79.5% reporting cure or improvement compared to 54.8% of subjects on tolterodine
  • No difference in efficacy or quality of life
  • Higher frequency of constipation and dry mouth in the medication arm of the study

Highlights from the STEP Study6

  • Extension of SUmiT
  • ~75% of patients who initially responded had long-term, sustained efficacy
  • Provides guidance on maintenance therapy beyond initial 12-week treatment
  • Treatment tapering at 13-16 weeks

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.


1

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. J Urol. 2009;182(3):1055-1061.

2

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. J Urol. 2010;183(4):1438-1443.

3

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.

4

Bellette PO, Rodrigues-Palma PC, Herman V, Riccetto C, Bigozzi M, Olivares JM. Posterior tibial nerve stimulation in the management of overactive bladder: a prospective and controlled study. Actas Urol Esp. 2009;33(1):58-63.

5

Finazzi-Agrò E, Petta F, Sciobica F, Pasqualetti P, Musco S, Bove P. Percutaneous tibial nerve stimulation effects on detrusor overactivity incontinence are not due to a placebo effect: a randomized, double-blind, placebo controlled trial. J Urol. 2010;184(5):2001-2006.

6

Peters KM, Carrico DJ, Wooldridge LS, Miller CJ, MacDiarmid SA. 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.

7

Soliman Y, Meyer R, Baum N. Falls in the Elderly Secondary to Urinary Symptoms. Reviews in Urology. 2016;18(1):28-32.