Overactive Bladder

Overactive bladder involves the symptoms of urgency, frequency, urge incontinence, and nocturia.  Men and women with overactive bladder have lower quality of life, depression status, and poorer quality of sleep. Overactive bladder is also prevalent, affecting 16% of American adults, yet most of this group continues to suffer from bothersome symptoms.

AVAILABLE THERAPIES HAVE SIGNIFICANT WEAKNESSES 

SOLUTION

A fully-implantable, radically small device called eCoin is implanted in the lower leg where it stimulates the tibial nerve.

HOW eCoin FOR OAB WORKS

Stimulation of afferent tibial nerve fibers causes an inhibition of the micturition pathway in the spinal cord.  From there, either the pelvic or the pudendal or both nerves act on the bladder to inhibit overactivity.  Interestingly, the same spinal roots (L4-S3) are targeted by sacral nerve stimulation (SNS) but the response to SNS is acute and thus its mechanism is somewhat distinct.

PERCUTANEOUS TIBIAL NERVE STIMULATION WORKS

Alves AT, Jácomo RH, Bontempo AP, Gomide LB, Botelho TL, Rett MT, Garcia PA. Randomized Trial of Tibial Nerve Stimulation (TNS) in Motor an Sensory Thresholds for Treating Overactive Bladder (OAB) in Older Women–Pilot Study. InNeurology and Urodynamics 2015 Aug 1 (Vol. 34, pp. S227-S228). 111 River St, Hoboken 07030-5774, NJ USA: Wiley-Blackwell.
Cho D, Lukan J, Uberoi P, Phillips T, Jellison F. Efficacy of Percutaneous Tibial Nerve Stimulation for Refractory Idiopathic Overactive Bladder at a Military Institution. Neurourology and Urodynamics 2016 Feb 1 (Vol. 35, pp. S66-S66). 111 River St, Hoboken 07030-5774, NJ USA: Wiley-Blackwell.
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. The Journal of urology. 2010 Nov 30;184(5):2001-6.
Klingler HC, Pycha A, Schmidbauer J, Marberger M. Use of peripheral neuromodulation of the S3 region for treatment of detrusor overactivity: a urodynamic-based study. Urology. 2000 Nov 30;56(5):766-71.
MacDiarmid SA, Peters KM, Shobeiri SA, Wooldridge LS, Rovner ES, Leong FC, Siegel SW, Tate SB, Feagins BA. Long-term durability of percutaneous tibial nerve stimulation for the treatment of overactive bladder. The Journal of Urology. 2010 Jan 31;183(1):234-40.
Moazzam Z, Duke AR, Yoo PB. Inhibition and Excitation of Bladder Function by Tibial Nerve Stimulation Using a Wirelessly Powered Implant: An Acute Study in Anesthetized Cats. The Journal of Urology. 2016 May 3.
Peters KM, MacDiarmid SA, Wooldridge LS, Leong FC, Shobeiri SA, Rovner ES, Siegel SW, Tate SB, Jarnagin BK, Rosenblatt PL, Feagins BA. Randomized trial of percutaneous tibial nerve stimulation versus extended-release tolterodine: results from the overactive bladder innovative therapy trial. The Journal of Urology. 2009 Sep 30;182(3):1055-61.
van der Pal F, Heesakkers JP, Bemelmans BL. Current opinion on the working mechanisms of neuromodulation in the treatment of lower urinary tract dysfunction. Current Opinion in Urology. 2006 Jul 1;16(4):261-7.
van der Pal F, van Balken M, Heesakkers JP, Bebruyne F, Bemelmans B. Intensive percutaneous tibial nerve stimulation in the treatment of urge urinary incontinence does not increase the success rate. Injoint meeting of the International Continence Society/International Urogynecological Association, Paris, France 2004 Aug 25.
van der Pal F, van Balken MR, Heesakkers JP, Debruyne FM, Bemelmans BL. Implant‐Driven Tibial Nerve Stimulation in the Treatment of Refractory Overactive Bladder Syndrome: 12‐Month Follow‐up. Neuromodulation: Technology at the Neural Interface. 2006 Apr 1;9(2):163-71.
Yoong W, Ridout AE, Damodaram M, Dadswell R. Neuromodulative treatment with percutaneous tibial nerve stimulation for intractable detrusor instability: outcomes following a shortened 6‐week protocol. BJU international. 2010 Dec 1;106(11):1673-6.

TRACK RECORD

In an almost identical business opportunity, the leadership of Valencia took more than 30% share from the entrenched monopolist in just four years.  The architect who designed the spinal cord stimulator behind this accomplishment also architected Valencia’s eCoin.