Clinical utility of neurostimulation devices in the treatment of overactive bladder: current perspectives

Dick Aw Janssen, Frank Mj Martens, Liesbeth L de Wall, Hendrikje Mk van Breda, John Pfa Heesakkers, Dick Aw Janssen, Frank Mj Martens, Liesbeth L de Wall, Hendrikje Mk van Breda, John Pfa Heesakkers

Abstract

Objectives: This review describes the evidence from established and experimental therapies that use electrical nerve stimulation to treat lower urinary tract dysfunction.

Methods: Clinical studies on established treatments such as percutaneous posterior tibial nerve stimulation (P-PTNS), transcutaneous electrical nerve stimulation (TENS), sacral nerve stimulation (SNS) and sacral anterior root stimulation (SARS) are evaluated. In addition, clinical evidence from experimental therapies such as dorsal genital nerve (DGN) stimulation, pudendal nerve stimulation, magnetic nerve stimulation and ankle implants for tibial nerve stimulation are evaluated.

Results: SNS and P-PTNS have been investigated with high-quality studies that have shown proven efficacy for the treatment for overactive bladder (OAB). SARS has proven evidence-based efficacy in spinal cord patients and increases the quality of life. TENS seems inferior to other OAB treatments such as SNS and P-PTNS but is noninvasive and applicable for ambulant therapy. Results from studies on experimental therapies such as pudendal nerve stimulation seem promising but need larger study cohorts to prove efficacy.

Conclusion: Neurostimulation therapies have proven efficacy for bladder dysfunction in patients who are refractory to other therapies.

Significance: Refinement of neurostimulation therapies is possible. The aim should be to make the treatments less invasive, more durable and more effective for the treatment of lower urinary tract dysfunction.

Keywords: PTNS; implant; neuromodulation; overactive bladder syndrome; sacral anterior root stimulation; sacral nerve stimulation.

Conflict of interest statement

Disclosure The authors report no conflicts of interest in this work.

Figures

Figure 1
Figure 1
Summary of therapeutic options (clinical and experimental) for electrical nerve stimulation for lower urinary tract dysfunction. Notes: (A) Different sites where electrical nerve stimulation is applied for the treatment of lower urinary tract dysfunction. (B) An X-ray image (AP) of the right ankle area of a patient who has an Urgent-SQ™ implantable device for on demand posterior tibial nerve stimulation. The yellow arrow depicts the wire electrode fixation near the posterior tibial nerve. (C) An X-ray image (lateral) of a right ankle of a patient with a BlueWind® implantable device for on demand posterior tibial nerve stimulation. The electrodes are positioned on the upper and lower sides of the device (green arrows). (D) An X-ray (AP) of the pelvic area from a patient undergoing the PNE test phase for evaluation if SNS is effective. The green arrow is the percutaneously placed wire electrode that is inserted through the left S3 foramen. If effective, the patient will receive a permanent tined lead electrode and in a later phase an InterStim implant. Abbreviations: AP, anterior posterior view; CNS, central nervous system; DGN, dorsal genital nerve; PNE, percutaneous nerve evaluation; SNS, sacral nerve stimulation; PMC, pontine micturition center.
Figure 2
Figure 2
Pelvic nerve anatomy and lower urinary tract neural control. Notes: (A) A model of the different nerves that innervate and control the lower urinary tract. (B) Pelvic nerve anatomy. Abbreviations: CNS, central nervous system; PMC, pontine micturition center.
Figure 3
Figure 3
SARS therapy for spinal cord injury patients. Notes: (A) How anterior roots S2, S3 and S4 are connected to electrodes in an electrode book. The electrodes are guided to an internal receiver (called a Chimney procedure). The receiver can be activated with an external controller. The two “X” depict a laminectomy to gain access to the nerves (for the intradural procedure) and a rhizotomy of the dorsal horn of S2–S4. (B) An X-ray image (AP) of the upper pelvic area of a patient with a Finetech–Brindley System. The yellow arrow depicts the electrode book where the electrodes are connected to the anterior roots of S2, S3 and S4. The wire electrodes are guided to the internal electrical pulse receiver plate that is shown as the green triangle. Abbreviations: AP, anterior posterior view; SARS, sacral anterior root stimulation.
Figure 4
Figure 4
Sacral nerve stimulation with InterStim® device and pelvic anatomy for dorsal genital nerve (DGN) stimulation and percuteneous tibial nerve stimulation. Notes: (A) A schematic diagram of how sacral nerve stimulation (SNS) works with a tined lead electrode that is placed through sacral foramen S3. The nerve fibers from the posterior tibial nerve are part of the large sciatic nerve that descends from the pelvic region toward the lower extremities. Also the pudendal nerve is shown, which contains the nerve fibers from the DGN, which branches from this nerve and can be used for electrical DGN stimulation. (B) An X-ray of the pelvic region from a patient with an InterStim SNS device with the green arrow pointing at the tined lead. The pulse generator is seen in the upper right corner of the image. (C) An image of an SNS device that was explanted. This was the first SNS device that was implanted in Europe in 1989. Abbreviations: DGN, dorsal genital nerve; SNS, sacral nerve stimulation.

References

    1. de Groat WC, Griffiths D, Yoshimura N. Neural control of the lower urinary tract. Compr Physiol. 2015;5(1):327–396.
    1. Andersson KE, Arner A. Urinary bladder contraction and relaxation: physiology and pathophysiology. Physiol Rev. 2004;84(3):935–986.
    1. Fowler CJ, Griffiths D, de Groat WC. The neural control of micturition. Nat Rev Neurosci. 2008;9(6):453–466.
    1. Wein AJ, Rackley RR. Overactive bladder: a better understanding of pathophysiology, diagnosis and management. J Urol. 2006;175(3 pt 2):5–10.
    1. Nakipoglu GF, Kaya AZ, Orhan G, et al. Urinary dysfunction in multiple sclerosis. J Clin Neurosci. 2009;16(10):1321–1324.
    1. Abrams P, Kelleher CJ, Kerr LA, Rogers RG. Overactive bladder significantly affects quality of life. Am J Manag Care. 2000;6(11 Suppl):S580–S590.
    1. Araki I, de Groat WC. Developmental synaptic depression underlying reorganization of visceral reflex pathways in the spinal cord. J Neurosci. 1997;17(21):8402–8407.
    1. Drake MJ, Apostolidis A, Cocci A, et al. Neurogenic lower urinary tract dysfunction: clinical management recommendations of the Neurologic Incontinence Committee of the fifth International Consultation on Incontinence 2013. Neurourol Urodyn. 2016;35(6):657–665.
    1. Dmochowski RR, Gomelsky A. Update on the treatment of overactive bladder. Curr Opin Urol. 2011;21:286–290.
    1. Lucas MG, Bosch RJ, Burkhard FC, et al. EAU guidelines on assessment and nonsurgical management of urinary incontinence. Eur Urol. 2012;62(6):1130–1142.
    1. de Groat WC, Griffiths D, Yoshimura N. Neural Control of the Lower Urinary Tract. Compr Physiol. 2015;5(1):327–396.
    1. Fowler CJ, Griffiths D, de Groat WC. The neural control of micturition. Nat Rev Neurosci. 2008;9(6):453–466.
    1. Yoshikawa S, Kawamorita N, Oguchi T, et al. Pelvic organ cross-sensitization to enhance bladder and urethral pain behaviors in rats with experimental colitis. Neuroscience. 2015;284:422–429.
    1. de Groat WC, Tai C. Impact of bioelectronic medicine on the neural regulation of pelvic visceral function. Bioelectron Med. 2015:25–36.
    1. Gebhart GF. Descending modulation of pain. Neurosci Biobehav Rev. 2004;27(8):729–737.
    1. Reynolds WS, Dmochowski R, Wein A, Bruehl S. Does central sensitization help explain idiopathic overactive bladder? Nat Rev Urol. 2016;13(8):481–491.
    1. Winnard LP, Dmitrieva N, Berkley KJ. Cross-organ interactions between reproductive gastrointestinal, and urinary tracts: modulation by estrous stage and involvement of the hypogastric nerve. Am J Physiol Regul Integr Comp Physiol. 2006;291(6):1592–1601.
    1. Malykhina AP. Neural mechanisms of pelvic organ cross-sensitization. Neuroscience. 2007;149(3):660–672.
    1. Pezzone MA, Liang R, Fraser MO. A model of neural cross-talk and irritation in the pelvis: implications for the overlap of chronic pelvic pain disorders. Gastroenterology. 2005;128(7):1953–1964.
    1. Finazzi-Agr 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.
    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. J Urol. 2010;183(4):1438–1443.
    1. Zhang F, Zhao S, Shen B, et al. Neural pathways involved in sacral neuromodulation of reflex bladder activity in cats. Am J Physiol Renal Physiol. 2013;304(6):710–717.
    1. Wang Y, Hassouna MM. Neuromodulation reduces c-fos gene expression in spinalized rats: a double-blind randomized study. J Urol. 2000;163(6):1966–1970.
    1. Xiao Z, Rogers MJ, Shen B, et al. Somatic modulation of spinal reflex bladder activity mediated by nociceptive bladder afferent nerve fibers in cats. Am J Physiol Renal Physiol. 2014;307(6):673–679.
    1. Brindley GS. Sacral root and hypogastric plexus stimulators and what these models tell us about autonomic actions of the bladder and urethra. Clin Sci (Lond) 1983;70:41s–44s.
    1. Blok BF, Groen J, Bosch JL, Veltman DJ, Lammertsma AA. Different brain effects during chronic and acute sacral neuromodulation in urge incontinent patients with implanted neurostimulators. BJU Int. 2006;98(6):1238–1243.
    1. Kavia R, Dasgupta R, Critchley H, Fowler C, Griffiths D. A functional magnetic resonance imaging study of the effect of sacral neuromodulation on brain responses in women with Fowler’s syndrome. BJU Int. 2010;105(3):366–372.
    1. Brindley GS, Polkey CE, Rushton DN, Cardozo L. Sacral anterior root stimulators for bladder control in paraplegia: the first 50 cases. J Neurol Neurosurg Psychiatry. 1986;49(10):1104–1114.
    1. Brindley GS, Rushton DN. Long-term follow-up of patients with sacral anterior root stimulator implants. Paraplegia. 1990;28(8):469–475.
    1. Martens FM, den Hollander PP, Snoek GJ, Koldewijn EL, van Kerrebroeck PE, Heesakkers JP. Quality of life in complete spinal cord injury patients with a Brindley bladder stimulator compared to a matched control group. Neurourol Urodyn. 2011;30(4):551–555.
    1. van Voskuilen AC, Oerlemans DJ, Weil EH, de Bie RA, van Kerrebroeck PE. Long term results of neuromodulation by sacral nerve stimulation for lower urinary tract symptoms: a retrospective single center study. Eur Urol. 2006;49(2):366–372.
    1. Dmochowski RR, Gomelsky A. Update on the treatment of overactive bladder. Curr Opin Urol. 2011;21(4):286–290.
    1. Chancellor MB, Chartier-Kastler EJ. Principles of Sacral Nerve Stimulation (SNS) for the treatment of bladder and urethral sphincter dysfunctions. Neuromodulation. 2000;3(1):16–26.
    1. Leng WW, Chancellor MB. How sacral nerve stimulation neuromodulation works. Urol Clin North Am. 2005;32(1):11–18.
    1. Spinelli M, Sievert KD. Latest technologic and surgical developments in using InterStim Therapy for sacral neuromodulation: impact on treatment success and safety. Eur Urol. 2008;54(6):1287–1296.
    1. Pham K, Guralnick ML, O’Connor RC. Unilateral versus bilateral stage I neuromodulator lead placement for the treatment of refractory voiding dysfunction. Neurourol Urodyn. 2008;27(8):779–781.
    1. Scheepens WA, de Bie RA, Weil EH, van Kerrebroeck PE. Unilateral versus bilateral sacral neuromodulation in patients with chronic voiding dysfunction. J Urol. 2002;168(5):2046–2050.
    1. Kessler TM, Madersbacher H, Kiss G. Prolonged sacral neuromodulation testing using permanent leads: a more reliable patient selection method? Eur Urol. 2005;47(5):660–665.
    1. Leong RK, De Wachter SGG, Nieman FHM, de Bie RA, van Kerrebroeck PEV. PNE versus 1st stage tined lead procedure: a direct comparison to select the most sensitive test method to identify patients suitable for sacral neuromodulation therapy. Neurourol Urodyn. 2011;30(7):1249–1252.
    1. van Kerrebroeck PEV, van Voskuilen AC, Heesakkers J, et al. Results of sacral neuromodulation therapy for urinary voiding dysfunction: outcomes of a prospective, worldwide clinical study. J Urol. 2007;178(5):2029–2034.
    1. Siddiqui NY, Wu JM, Amundsen CL. Efficacy and adverse events of sacral nerve stimulation for overactive bladder: a systematic review. Neurourol Urodyn. 2010;29(suppl 1):S18–S23.
    1. Siegel SW, Catanzaro F, Dijkema HE, et al. Long-term results of a multicenter study on sacral nerve stimulation for treatment of urinary urge incontinence, urgency-frequency, and retention. Urology. 2000;56(6 suppl 1):87–91.
    1. Siegel S, Noblett K, Mangel J, et al. Three-year follow-up results of a prospective, multicenter study in overactive bladder subjects treated with sacral neuromodulation. Urology. 2016;94:57–63.
    1. Vandoninck V, Van Balken MR, Agrò EF, et al. Posterior tibial nerve stimulation in the treatment of urge incontinence. Neurourol Urodyn. 2003;22(1):17–23.
    1. Staskin DR, Peters KM, MacDiarmid S, Shore N, de Groat WC. Percutaneous tibial nerve stimulation: a clinically and cost effective addition to the overactive bladder algorithm of care. Curr Urol Rep. 2012;13(5):327–334.
    1. McGuire EJ, Zhang SC, Horwinski ER, Lytton B. Treatment of motor and sensory detrusor instability by electrical stimulation. J Urol. 1983;129(1):78–79.
    1. Burton C, Sajja A, Latthe PM. Effectiveness of percutaneous posterior tibial nerve stimulation for overactive bladder: a systematic review and meta-analysis. Neurourol Urodyn. 2012;31(8):1206–1216.
    1. Govier FE, Litwiller S, Nitti V, Kreder KJ, Jr, Rosenblatt P. Percutaneous afferent neuromodulation for the refractory overactive bladder: results of a multicenter study. J Urol. 2001;165(4):1193–1198.
    1. Capitanucci ML, Camanni D, Demelas F, Mosiello G, Zaccara A, De Gennaro M. Long-term efficacy of percutaneous tibial nerve stimulation for different types of lower urinary tract dysfunction in children. J Urol. 2009;182(4 suppl):2056–2061.
    1. Finazzi-Agr 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;184:2001–2006.
    1. Peters K, Carrico D, Burks F. Validation of a sham for percutaneous tibial nerve stimulation (PTNS) Neurourol Urodyn. 2009;28(1):58–61.
    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. 2011;1055:182.
    1. MacDiarmid SA, Peters KM, Shobeiri SA, et al. Long-term durability of percutaneous tibial nerve stimulation for the treatment of overactive bladder. J Urol. 2010;183(1):234–240.
    1. 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. 2006;9(2):163–171.
    1. Janssen DA, Farag F, Heesakkers JP. Urgent-SQ implant in treatment of overactive bladder syndrome: 9-year follow-up study. Neurourol Urodyn. 2013;32(5):472–475.
    1. Martens FM, Heesakkers JP, Rijkhoff NJ. Surgical access for electrical stimulation of the pudendal and dorsal genital nerves in the overactive bladder: a review. J Urol. 2011;186(3):798–804.
    1. Martens FM, Heesakkers JP, Rijkhoff NJ. Minimal invasive electrode implantation for conditional stimulation of the dorsal genital nerve in neurogenic detrusor overactivity. Spinal Cord. 2011;49(4):566–572.
    1. Goldman HB, Amundsen CL, Mangel J, et al. Dorsal genital nerve stimulation for the treatment of overactive bladder symptoms. Neurourol Urodyn. 2008;27(6):499–503.
    1. van Breda HM, Farag FF, Martens FM, Heesakkers JP, Rijkhoff NJ. Subject-controlled, on-demand, dorsal genital nerve stimulation to treat urgency urinary incontinence; a pilot. Front Neurosci. 2016;10:24.
    1. Spinelli M, Malaguti S, Giardiello G, Lazzeri M, Tarantola J, Van Den Hombergh U. A new minimally invasive procedure for pudendal nerve stimulation to treat neurogenic bladder: description of the method and preliminary data. Neurourol Urodyn. 2005;24(4):305–309.
    1. Juenemann KP, Lue TF, Schmidt RA, Tanagho EA. Clinical significance of sacral and pudendal nerve anatomy. J Urol. 1988;139(1):74–80.
    1. Groen J, Amiel C, Bosch JL. Chronic pudendal nerve neuromodulation in women with idiopathic refractory detrusor overactivity incontinence: results of a pilot study with a novel minimally invasive implantable mini-stimulator. Neurourol Urodyn. 2005;24(3):226–230.
    1. Peters KM, Feber KM, Bennett RC. Sacral versus pudendal nerve stimulation for voiding dysfunction: a prospective, single-blinded, randomized, crossover trial. Neurourol Urodyn. 2005;24(7):643–647.
    1. Wang S, Zhang S, Zhao L. Long-term efficacy of electrical pudendal nerve stimulation for urgency-frequency syndrome in women. Int Urogynecol J. 2014;25(3):397–402.
    1. Fjorback MV, Van Rey FS, Rijkhoff NJ, Nøhr M, Petersen T, Heesakkers JP. Electrical stimulation of sacral dermatomes in multiple sclerosis patients with neurogenic detrusor overactivity. Neurourol Urodyn. 2007;26(4):525–530.
    1. Gross T, Schneider MP, Bachmann LM, et al. Transcutaneous electrical nerve stimulation for treating neurogenic lower urinary tract dysfunction: a systematic review. Eur Urol. 2016;69(6):1102–1111.
    1. Guo ZF, Liu Y, Hu GH, Liu H, Xu YF. Transcutaneous electrical nerve stimulation in the treatment of patients with poststroke urinary incontinence. Clin Interv Aging. 2014;9:851–856.
    1. Opisso E, Borau A, Rijkhoff NJ. Subject-controlled stimulation of dorsal genital nerve to treat neurogenic detrusor overactivity at home. Neurourol Urodyn. 2013;32(7):1004–1009.
    1. Farag FF, Martens FM, Rijkhoff NJ, Heesakkers JP. Dorsal genital nerve stimulation in patients with detrusor overactivity: a systematic review. Curr Urol Rep. 2012;13(5):385–388.
    1. Barker AT, Freeston IL, Jalinous R, Jarratt JA. Magnetic stimulation of the human brain and peripheral nervous system: an introduction and the results of an clinical initial evaluation. Neurosurgery. 1987;20(1):100.
    1. Fujishiro T, Enomoto H, Ugawa Y, Takahashi S, Ueno S, Kitamura T. Magnetic stimulation of the sacral roots for the treatment of stress incontinence: an investigational study and placebo controlled trial. J Urol. 2000;164(4):1277–1279.
    1. Lo TS, Tseng LH, Lin YH, Liang CC, Lu CY, Pue LB. Effect of extracorporeal magnetic energy stimulation on bothersome lower urinary tract symptoms and quality of life in female patients with stress urinary incontinence and overactive bladder. J Obstet Gynaecol Res. 2013;39(11):1526–1532.

Source: PubMed

3
Prenumerera