Top

Advances in Therapy

Published in:

Open Access 01-04-2021 | Magnetic Resonance Imaging | Original Research

Systematic Literature Review and Meta-Analysis of Sacral Neuromodulation (SNM) in Patients with Neurogenic Lower Urinary Tract Dysfunction (nLUTD): Over 20 Years’ Experience and Future Directions

Authors: Arndt van Ophoven, Stefan Engelberg, Helen Lilley, Karl-Dietrich Sievert

Published in: Advances in Therapy | Issue 4/2021

Abstract

Introduction

Sacral neuromodulation (SNM) has been used in carefully selected patients with neurogenic lower urinary tract dysfunctions (nLUTD) for over two decades.

Methods

The aim of the current work was to perform a systematic literature review and meta-analysis of studies reporting the safety and effectiveness of SNM in patients with nLUTD (neurogenic detrusor overactivity, non-obstructive urinary retention, or a combination of both). For this purpose a systematic literature research was conducted using Embase (OvidSP), MEDLINE (OvidSP), MEDLINE In-Process Citations & Daily Update (OvidSP), MEDLINE (OvidSP) e-Pub ahead of print, Cochrane Central Register of Controlled Trials (CENTRAL), NIH Clinicaltrials.gov, and WHO International Clinical Trials Registry Platform (ICTRP) between 1998 and March 2020, supplemented by a hand search.

Results

Forty-seven studies were included in the systematic literature review. Twenty-one studies comprising a total of 887 patients were included in the meta-analysis of test SNM. The pooled success rate of SNM test stimulation was 66.2% (95% CI 56.9–74.4). Depending on neurogenic conditions test success rates varied greatly. Twenty-four studies with a total of 428 patients were included in the meta-analysis of permanent SNM. The success rate of pooled permanent SNM was 84.2% (95% CI 77.8–89.0). Among the identified studies, the most common adverse events (AEs) were loss of effectiveness, infection, pain at implant site, and lead migration with AE rates of 4.7%, 3.6%, 3.2%, and 3.2%, respectively. Limitations entail lower level of evidence (Oxford classification 3–4) of included studies, significant risk of bias, small sample sizes in some studies, the inclusion of retrospective case series, substantial between-study heterogeneity, heterogeneous patient populations, insufficient disease classification, and variations in terms of outcome parameters as well as techniques. Furthermore, long-term data are limited.

Conclusion

This meta-analysis supports not only the benefits of permanent SNM for various nLUTDs but also high overall success rates, similar to idiopathic patients. Current data of the analyzed studies showed that SNM is safe for these patients. However, more vigorous studies and/or registries are needed before definitive conclusions can be drawn.

Available only for authorised users

Liberman D, Ehlert MJ, Siegel SW. Sacral neuromodulation in urological practice. Urology. 2017;99:14–22.PubMed

Schmidt RA, Jonas U, Oleson KA, et al. Sacral nerve stimulation for treatment of refractory urinary urge incontinence. Sacral Nerve Stimulation Study Group. J Urol. 1999;162(2):352–7.PubMed

Hassouna MM, Siegel SW, Nÿeholt AA, et al. Sacral neuromodulation in the treatment of urgency-frequency symptoms: a multicenter study on efficacy and safety. J Urol. 2000;163(6):1849–54.PubMed

Jonas U, Fowler CJ, Chancellor MB, et al. Efficacy of sacral nerve stimulation for urinary retention: results 18 months after implantation. J Urol. 2001;165(1):15–9.PubMed

Gajewski JB, Hassouna MM, Corcos J, Gray GJ, Tu LM, Dwyer N. The history of sacral neuromodulation in Canada. Can Urol Assoc J. 2020;14(4):87–90.PubMedPubMedCentral

Tanagho EA, Schmidt RA, Orvis BR. Neural stimulation for control of voiding dysfunction: a preliminary report in 22 patients with serious neuropathic voiding disorders. J Urol. 1989;142(2 Pt 1):340–5.PubMed

Agrawal S, Agrawal RR, Wood HM. Establishing a multidisciplinary approach to the management of neurologic disease affecting the urinary tract. Urol Clin North Am. 2017;44(3):377–89.PubMed

Mehnert U, Chartier-Kastler E, de Wachter S, van Kerrebroeck P, van Koeveringe G. The management of urine storage dysfunction in the neurological patient. SN Compr Clin Med. 2018;1(3):160–82.

Tijnagel MJ, Scheepe JR, Blok BF. Real life persistence rate with antimuscarinic treatment in patients with idiopathic or neurogenic overactive bladder: a prospective cohort study with solifenacin. BMC Urol. 2017;17(1):30. https://doi.org/10.1186/s12894-017-0216-4.CrossRefPubMedPubMedCentral

10.

Patel DP, Herrick JS, Stoffel JT, et al. Reasons for cessation of clean intermittent catheterization after spinal cord injury: results from the Neurogenic Bladder Research Group spinal cord injury registry. Neurourol Urodyn. 2020;39(1):211–9.PubMed

11.

Leitner L, Guggenbühl-Roy S, Knüpfer SC, et al. More than 15 years of experience with intradetrusor onabotulinumtoxinA injections for treating refractory neurogenic detrusor overactivity: lessons to be learned. Eur Urol. 2016;70(3):522–8.PubMed

12.

Kessler TM, La Framboise D, Trelle S, et al. Sacral neuromodulation for neurogenic lower urinary tract dysfunction: systematic review and meta-analysis. Eur Urol. 2010;58(6):865–74.PubMed

13.

EAU Guidelines 2020. https://uroweb.org/guideline/neurourology/#3. Accessed 25 Aug 2020.

14.

De Wachter S, Knowles CH, Elterman DS, et al. New technologies and applications in sacral neuromodulation: an update. Adv Ther. 2020;37(2):637–43.PubMed

15.

Hennessey A, Robertson NP, Swingler R, Compston DA. Urinary, faecal and sexual dysfunction in patients with multiple sclerosis. J Neurol. 1999;246(11):1027–32.PubMed

16.

Traboulsee A, Simon JH, Stone L, et al. Revised recommendations of the consortium of MS centers task force for a standardized MRI protocol and clinical guidelines for the diagnosis and follow-up of multiple sclerosis. AJNR Am J Neuroradiol. 2016;37(3):394–401.PubMedPubMedCentral

17.

Kaunzner UW, Gauthier SA. MRI in the assessment and monitoring of multiple sclerosis: an update on best practice. Ther Adv Neurol Disord. 2017;10(6):247–61.PubMedPubMedCentral

18.

Bodley R. Imaging in chronic spinal cord injury–indications and benefits. Eur J Radiol. 2002;42(2):135–53.PubMed

19.

Pagliacci MC, Franceschini M, Di Clemente B, Agosti M, Spizzichino L, GISEM. A multicentre follow-up of clinical aspects of traumatic spinal cord injury. Spinal Cord. 2007;45(6):404–10.PubMed

20.

Moher D, Shamseer L, Clarke M, et al. Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015 statement. Syst Rev. 2015;1(4):1.

21.

Marinkovic SP, Gillen LM. Sacral neuromodulation for multiple sclerosis patients with urinary retention and clean intermittent catheterization. Int Urogynecol J. 2010;21:223–8.PubMed

22.

Howick J, Chalmers I, Glasziou P, et al. The Oxford 2011 levels of evidence. 2011. https://www.cebm.ox.ac.uk/resources/levels-of-evidence/ocebm-levels-ofevidence. Accessed 25 Aug 2020.

23.

Sterne JA, Hernán MA, Reeves BC, et al. ROBINS-I: a tool for assessing risk of bias in non-randomised studies of interventions. BMJ. 2016;12(355):i4919. https://doi.org/10.1136/bmj.i4919.CrossRef

24.

McGuinness LA, Higgins JPT. Risk-of-bias VISualization (robvis): an R package and Shiny web app for visualizing risk-of-bias assessments. Res Syn Meth. 2020. https://doi.org/10.1002/jrsm.1411].CrossRef

25.

R Core Team. R: A language and environment for statistical computing [Internet]. Vienna, Austria: R Foundation for Statistical Computing; 2019. https://www.r-project.org/.

26.

Carone R, Bertapelle P, Zanollo A, et al. Sacral neuromodulation in neurogenic lower urinary tract dysfunctions: results of a multicenter study group. Urodinamica. 1999;9:177–82.

27.

Minardi D, Muzzonigro G. Lower urinary tract and bowel disorders and multiple sclerosis: role of sacral neuromodulation: a preliminary report. Neuromodulation. 2005;8:176–81.PubMed

28.

Dudding TC, Hollingshead JR, Nicholls RJ, Vaizey CJ. Sacral nerve stimulation for faecal incontinence: patient selection, service provision and operative technique. Colorectal Dis. 2011;13(8):e187–95.PubMed

29.

Hohenfellner M, Humke J, Hampel C, et al. Chronic sacral neuromodulation for treatment of neurogenic bladder dysfunction: long-term results with unilateral implants. Urology. 2001;58:887–92.PubMed

30.

Schurch B, Reilly I, Reitz A, Curt A. Electrophysiological recordings during the peripheral nerve evaluation (PNE) test in complete spinal cord injury patients. World J Urol. 2003;20:319–22.PubMed

31.

Sievert K-D, Amend B, Gakis G, et al. Early sacral neuromodulation prevents urinary incontinence after complete spinal cord injury. Ann Neurol. 2010;67:74–84.PubMed

32.

Al-Azzawi IS, Al-Tamimi MAJ. The first Iraqi experience in sacral neuromodulation for patients with lower urinary tract dysfunction. Arab J Urol. 2018;16:391–6.PubMedPubMedCentral

33.

Arlen AM, Powell CR, Kreder KJ. Sacral neuromodulation for refractory urge incontinence is less effective following spinal surgery. Sci World J. 2011;11:142–6.

34.

Chaabane W, Guillotreau J, Castel-lacanal E, et al. Sacral neuromodulation for treating neurogenic bladder dysfunction: clinical and urodynamic study. Neurourol Urodyn. 2011;30:547–50.PubMed

35.

Chartier-Kastler EJ, Ruud Bosch JL, Perrigot M, Chancellor MB, Richard F, Denys P. Long-term results of sacral nerve stimulation (S3) for the treatment of neurogenic refractory urge incontinence related to detrusor hyperreflexia. J Urol. 2000;164:1476–80.PubMed

36.

Chen G, Liao L. Sacral neuromodulation for neurogenic bladder and bowel dysfunction with multiple symptoms secondary to spinal cord disease. Spinal Cord. 2015;53:204–8.PubMed

37.

Daniels DH, Powell CR, Braasch MR, Kreder KJ. Sacral neuromodulation in diabetic patients: success and complications in the treatment of voiding dysfunction. Neurourol Urodyn. 2010;29(4):578–81.PubMed

38.

Denzinger S, Nowrotek A, Weingart P, et al. Does sacral neuromodulation lead to relevant reduction in the need for intermittent catheterization? A single-center experience on patients with chronic urinary retention. Neuromodulation Technol Neural Interface. 2012;15:586–91.

39.

Dobberfuhl AD, Mahal A, Dallas KB, Choi KM, Comiter CV, Elliott CS. Statewide success of staged sacral neuromodulation for the treatment of urinary complaints in California (2005–2011). Female Pelvic Med Reconstr Surg. 2018. https://doi.org/10.1097/SPV.0000000000000605.CrossRef

40.

Engeler DS, Meyer D, Abt D, Müller S, Schmid H-P. Sacral neuromodulation for the treatment of neurogenic lower urinary tract dysfunction caused by multiple sclerosis: a single-centre prospective series. BMC Urol. 2015;15:105. https://doi.org/10.1186/s12894-015-0102-x.CrossRefPubMedPubMedCentral

41.

Lansen-Koch SMP, Govaert B, Oerlemans D, et al. Sacral nerve modulation for defaecation and micturition disorders in patients with spina bifida. Colorectal Dis. 2012;14:508–14.PubMed

42.

Lavano A, Volpentesta G, Aloisi M, Veltri C, Piragine G, Signorelli CD. Use of chronic sacral nerve stimulation in neurological voiding disorders. J Neurosurg Sci. 2004;48:157–9.PubMed

43.

Lombardi G, Musco S, Celso M, Del Corso F, Del Popolo G. Sacral neuromodulation for neurogenic non-obstructive urinary retention in incomplete spinal cord patients: a ten-year follow-up single-centre experience. Spinal Cord. 2014;52:241–5.PubMed

44.

Minardi D, Muzzonigro G. Sacral neuromodulation in patients with multiple sclerosis. World J Urol. 2012;30:123–8.PubMed

45.

Peters KM, Kandagatla P, Killinger KA, Wolfert C, Boura JA. Clinical outcomes of sacral neuromodulation in patients with neurologic conditions. Urology. 2013;81:738–44.PubMed

46.

Seif C, Eckermann J, Bross S, Portillo FJM, Jünemann K-P, Braun P-M. Findings with bilateral sacral neurostimulation: sixty-two PNE-tests in patients with neurogenic and idiopathic bladder dysfunctions. Neuromodulation. 2004;7:141–5.PubMed

47.

Spinelli M, Giardiello G, Gerber M, Arduini A, van den Hombergh U, Malaguti S. New sacral neuromodulation lead for percutaneous implantation using local anesthesia: description and first experience. J Urol. 2003;170:1905–7.PubMed

48.

Wallace PA, Lane FL, Noblett KL. Sacral nerve neuromodulation in patients with underlying neurologic disease. Am J Obstet Gynecol. 2007;197:96.e1-96.e5.

49.

Wöllner J, Krebs J, Pannek J. Sacral neuromodulation in patients with neurogenic lower urinary tract dysfunction. Spinal Cord. 2016;54:137–40.PubMed

50.

Zhang P, Wang JY, Zhang Y, et al. Results of sacral neuromodulation therapy for urinary voiding dysfunction: five-year experience of a retrospective, multicenter study in China. Neuromodulation. 2019;22(6):730–7.PubMed

51.

Amundsen CL, Romero AA, Jamison MG, Webster GD. Sacral neuromodulation for intractable urge incontinence: are there factors associated with cure? Urology. 2005;66:746–50.PubMed

52.

Andretta E, Simeone C, Ostardo E, Pastorello M, Zuliani C. Usefulness of sacral nerve modulation in a series of multiple sclerosis patients with bladder dysfunction. J Neurol Sci. 2014;347:257–61.PubMed

53.

Bertapelle P, Bodo G, Carone R. Detrusor acontractility in urinary retention: detrusor contractility test as exclusion criteria for sacral neurostimulation. J Urol. 2008;180(1):215–6.PubMed

54.

Hohenfellner M, Schultz-Lampel D, Dahms S, Matzel K, Thüroff JW. Bilateral chronic sacral neuromodulation for treatment of lower urinary tract dysfunction. J Urol. 1998;160(3 Pt 1):821–4.PubMed

55.

Ishigooka M, Suzuki Y, Hashimoto T, Sasagawa I, Nakada T, Handa Y. A new technique for sacral nerve stimulation: a percutaneous method for urinary incontinence caused by spinal cord injury. Br J Urol. 1998;81(2):315–8.PubMed

56.

Sharifiaghdas F. Sacral neuromodulation in congenital lumbo-sacral and traumatic spinal cord defects with neurogenic lower urinary tract symptoms: a single-center experience in children and adolescents. World J Urol. 2019;37(12):2775–83.PubMed

57.

Siegel S, Noblett K, Mangel J, et al. Five-year followup results of a prospective, multicenter study of patients with overactive bladder treated with sacral neuromodulation. J Urol. 2018;199(1):229–36.PubMed

58.

Noblett K, Siegel S, Mangel J, et al. Results of a prospective, multicenter study evaluating quality of life, safety, and efficacy of sacral neuromodulation at twelve months in subjects with symptoms of overactive bladder. Neurourol Urodyn. 2016;35(2):246–51.PubMed

59.

Bartley JM, Killinger KA, Boura J, et al. The impact of prior back surgery on neuromodulation outcomes: a review of over 500 patients. Neurourol Urodyn. 2017;36(6):1535–42.PubMed

60.

Lombardi G, Del Popolo G. Clinical outcome of sacral neuromodulation in incomplete spinal cord injured patients suffering from neurogenic lower urinary tract symptoms. Spinal Cord. 2009;47:486–91.PubMed

61.

Katkade VB, Sanders KN, Zou KH. Real world data: an opportunity to supplement existing evidence for the use of long-established medicines in health care decision making. J Multidiscip Healthc. 2018;11:295–304. https://doi.org/10.2147/JMDH.S160029.CrossRefPubMedPubMedCentral

62.

Hennessey DB, Hoag N, Gani J. Sacral neuromodulation for detrusor hyperactivity with impaired contractility. Neurourol Urodyn. 2017;36(8):2117–22.PubMed

63.

Lehur PA, Sørensen M, Dudding TC, et al. Programming algorithms for sacral neuromodulation: clinical practice and evidence-recommendations for day-to-day practice. Neuromodulation. 2020. https://doi.org/10.1111/ner.13117.CrossRefPubMedPubMedCentral

64.

Manjunath A, Keeter MK, Koloms K, Kielb SJ. Abdominal versus standard placement of the sacral nerve stimulator implantable pulse generator. Urology. 2019;127:49–52.PubMed

65.

Groen J, Ruud Bosch JL, van Mastrigt R. Sacral neuromodulation in women with idiopathic detrusor overactivity incontinence: decreased overactivity but unchanged bladder contraction strength and urethral resistance during voiding. J Urol. 2006;175(3 Pt 1):1005–9.PubMed

66.

Groenendijk PM, Lycklama à Nyeholt AA, Heesakkers JP, et al. Urodynamic evaluation of sacral neuromodulation for urge urinary incontinence. BJU Int. 2008;101(3):325–9.PubMed

67.

De Wachter S, Vaganee D, Kessler TM. Sacral neuromodulation: mechanism of action. Eur Urol Focus. 2020. https://doi.org/10.1016/j.euf.2019.11.018.CrossRefPubMed

68.

Krebs J, Pannek J. Effects of solifenacin in patients with neurogenic detrusor overactivity as a result of spinal cord lesion. Spinal Cord. 2013;51(4):306–9.PubMed

69.

Chen YC, Kuo HC. The therapeutic effects of repeated detrusor injections between 200 or 300 units of onabotulinumtoxinA in chronic spinal cord injured patients. Neurourol Urodyn. 2014;33(1):129–34.PubMed

70.

Hassouna MM, Elkelini MS. Early versus late treatment of voiding dysfunction with pelvic neuromodulation. Can Urol Assoc J. 2007;1(2):106–10. https://doi.org/10.5489/cuaj.52.CrossRefPubMedPubMedCentral

71.

Greenberg D, Sohlberg E, Zhang C, Comiter CV, Enemchukwu E. Sacral neuromodulation in Parkinson’s disease patients with neurogenic bladder. Neurourol Urodyn. 2019;38(S1):S204.

72.

Peyronnet B, Biardeau X, Cornu JN, et al. Sacral neuromodulation in patients with Parkinson’s disease: a multicenter study. Neurourol Urodyn. 2019;38(S1):S126.

73.

Joussain C, Phé V, Even A, Chartier-Kastler E, Denys P. Intradetrusor injection of botulinum toxin A and sacral neuromodulation for neurogenic detrusor overactivity. Eur J Phys Rehabil Med. 2017;53(6):991–7.PubMed

74.

Matzel KE, Chartier-Kastler E, Knowles CH, et al. Sacral neuromodulation: standardized electrode placement technique. Neuromodulation. 2017;20(8):816–24.PubMed

75.

Groen J, Blok BF, Bosch JL. Sacral neuromodulation as treatment for refractory idiopathic urge urinary incontinence: 5-year results of a longitudinal study in 60 women. J Urol. 2011;186(3):954–9.PubMed

76.

Knüpfer SC, Liechti MD, Mordasini L, et al. Protocol for a randomized, placebo-controlled, double-blind clinical trial investigating sacral neuromodulation for neurogenic lower urinary tract dysfunction. BMC Urol. 2014;14:65.PubMedPubMedCentral

77.

Sedrakyan A, Campbell B, Merino JG, Kuntz R, Hirst A, McCulloch P. IDEAL-D: a rational framework for evaluating and regulating the use of medical devices. BMJ. 2016;9(353):i2372. https://doi.org/10.1136/bmj.i2372.CrossRef

78.

Spinelli M. The future of sacral nerve stimulation. Pelviperineology. 2007;26:17–18. http://cms.galenos.com.tr/Uploads/Article_37222/Pelviperineology-26-17-En.pdf.

Title: Systematic Literature Review and Meta-Analysis of Sacral Neuromodulation (SNM) in Patients with Neurogenic Lower Urinary Tract Dysfunction (nLUTD): Over 20 Years’ Experience and Future Directions
Authors: Arndt van Ophoven
Stefan Engelberg
Helen Lilley
Karl-Dietrich Sievert
Publication date: 01-04-2021
Publisher: Springer Healthcare
Keywords: Magnetic Resonance Imaging
Magnetic Resonance Imaging
Multiple Sclerosis
Nerve Stimulation
Published in: Advances in Therapy / Issue 4/2021
Print ISSN: 0741-238X
Electronic ISSN: 1865-8652
DOI: https://doi.org/10.1007/s12325-021-01650-9

ACC 2024 Congress Coverage

Heart Failure Video

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Systematic Literature Review and Meta-Analysis of Sacral Neuromodulation (SNM) in Patients with Neurogenic Lower Urinary Tract Dysfunction (nLUTD): Over 20 Years’ Experience and Future Directions

Abstract

Introduction

Methods

Results

Conclusion

ACC 2024 Congress Coverage

Year in Review: Heart failure and cardiomyopathies

Semaglutide benefits people with type 2 diabetes and obesity-related heart failure

Incentivised to exercise

New intervention for STEMI-related cardiogenic shock

» View more highlights on the ACC 2024 congress hub page

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Abstract

Introduction

Methods

Results

Conclusion

Please log in to get access to this content

Other articles of this Issue 4/2021

Non-Invasive Respiratory Support for Management of the Perioperative Patient: A Narrative Review

Phase 2 Randomized Clinical Study of Netarsudil Ophthalmic Solution in Japanese Patients with Primary Open-Angle Glaucoma or Ocular Hypertension

Efficacy and Safety of the Biosimilar IBI301 Plus Standard CHOP (I-CHOP) in Comparison With Rituximab Plus CHOP (R-CHOP) in Patients with Previously Untreated Diffuse Large B-Cell Lymphoma (DLBCL): A Randomized, Double-Blind, Parallel-Group, Phase 3 Trial

Luspatercept: A Gigantic Step in the Treatment of Transfusion-Dependent β-Thalassemia Patients—a Quick Review

Safety and Efficacy of Perioperative Use of Evolocumab in Myocardial Infarction Patients: Study Protocol for a Multicentre Randomized Controlled Trial

EGFR and PDL1: A Match (Not) Made in Heaven—A Real-World Retrospective Analysis of PDL1 Expression in EGFR-Mutated NSCLC

ACC 2024 Congress Coverage

Year in Review: Heart failure and cardiomyopathies

Semaglutide benefits people with type 2 diabetes and obesity-related heart failure

Incentivised to exercise

New intervention for STEMI-related cardiogenic shock

» View more highlights on the ACC 2024 congress hub page