{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,23]],"date-time":"2026-06-23T01:45:36Z","timestamp":1782179136705,"version":"3.54.5"},"reference-count":17,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2024,3,22]],"date-time":"2024-03-22T00:00:00Z","timestamp":1711065600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2024,3,22]],"date-time":"2024-03-22T00:00:00Z","timestamp":1711065600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"Deutsche Gesellschaft f\u00fcr Koloproktologie"},{"DOI":"10.13039\/501100018935","name":"Universit\u00e4tsklinikum Erlangen","doi-asserted-by":"crossref","id":[{"id":"10.13039\/501100018935","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Trials"],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>A therapeutic effect of sacral neuromodulation (SNM) on fecal incontinence (FI) and quality of life has been proven in adults. SNM is, however, rarely used in pediatric cases. The aim of the study is to investigate effects of SNM in pediatric constipation in a prospective parallel-group trial.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      A monocentric, randomized, unblinded, parallel-group trial is conducted. SNM is conducted in the invasive variant and in an innovative, external approach with adhesive electrodes (enteral neuromodulation, ENM). We include patients with constipation according to the ROME IV criteria and refractory to conventional options. Patients with functional constipation and Hirschsprung\u2019s disease are able to participate. Participants are allocated in a 1:1 ratio to either SNM or ENM group. Clinical data and quality of life is evaluated in regular check-ups. Neuromodulation is applied continuously for 3 months (end point of the study) with follow-up-points at 6 and 12 months. Findings are analyzed statistically considering a 5% significance level (\n                      <jats:italic>p<\/jats:italic>\n                      \u2009\u2264\u20090.05). Outcome variables are defined as change in (1) episodes of abdominal pain, (2) episodes of FI, (3) defecation frequency, (4) stool consistency. Improvement of proprioception, influence on urinary incontinence, quality of life and safety of treatment are assessed as secondary outcome variables. We expect a relevant improvement in both study groups.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Discussion<\/jats:title>\n                    <jats:p>This is the first trial, evaluating effects of neuromodulation for constipation in children and adolescents and comparing effects of the invasive and non-invasive application (SNM vs. ENM).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>The study is registered with clinicaltrials.gov, Identifier NCT04713085 (date of registration 01\/14\/2021).<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1186\/s13063-024-08052-6","type":"journal-article","created":{"date-parts":[[2024,3,22]],"date-time":"2024-03-22T02:42:18Z","timestamp":1711075338000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Sacral neuromodulation for constipation and fecal incontinence in children and adolescents \u2013 study protocol of a prospective, randomized trial on the application of invasive vs. non-invasive technique"],"prefix":"10.1186","volume":"25","author":[{"given":"Manuel","family":"Besend\u00f6rfer","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Annemarie","family":"Kirchgatter","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roman","family":"Carbon","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christel","family":"Weiss","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hanna","family":"M\u00fcller","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Klaus E.","family":"Matzel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8864-3240","authenticated-orcid":false,"given":"Sonja","family":"Diez","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2024,3,22]]},"reference":[{"issue":"4","key":"8052_CR1","doi-asserted-by":"publisher","first-page":"O74","DOI":"10.1111\/codi.12905","volume":"17","author":"Y Maeda","year":"2015","unstructured":"Maeda Y, O\u2019Connell PR, Lehur PA, Matzel KE, Laurberg S. Sacral nerve stimulation for faecal incontinence and constipation: a European consensus statement. Colorectal Dis. 2015;17(4):O74-87.","journal-title":"Colorectal Dis"},{"issue":"1","key":"8052_CR2","doi-asserted-by":"publisher","first-page":"336","DOI":"10.1186\/s13063-018-2689-1","volume":"19","author":"E McAlees","year":"2018","unstructured":"McAlees E, Vollebregt PF, Stevens N, Dudding TC, Emmanuel AV, Furlong PL, Hamdy S, Hooper RL, Jones JFX, Norton C, et al. Efficacy and mechanism of sub-sensory sacral (optimised) neuromodulation in adults with faecal incontinence: study protocol for a randomised controlled trial. Trials. 2018;19(1):336.","journal-title":"Trials"},{"issue":"5","key":"8052_CR3","doi-asserted-by":"publisher","first-page":"762","DOI":"10.1002\/nau.21096","volume":"30","author":"B Amend","year":"2011","unstructured":"Amend B, Matzel KE, Abrams P, de Groat WC, Sievert KD. How does neuromodulation work. Neurourol Urodyn. 2011;30(5):762\u20135.","journal-title":"Neurourol Urodyn"},{"issue":"7608","key":"8052_CR4","doi-asserted-by":"publisher","first-page":"1370","DOI":"10.1136\/bmj.39231.633275.AD","volume":"334","author":"C Norton","year":"2007","unstructured":"Norton C, Thomas L, Hill J. Management of faecal incontinence in adults: summary of NICE guidance. BMJ. 2007;334(7608):1370\u20131.","journal-title":"BMJ"},{"key":"8052_CR5","doi-asserted-by":"publisher","first-page":"169","DOI":"10.3389\/fped.2020.00169","volume":"8","author":"M Besend\u00f6rfer","year":"2020","unstructured":"Besend\u00f6rfer M, Kohl M, Schellerer V, Carbon R, Diez S. A pilot study of non-invasive sacral nerve stimulation in treatment of constipation in childhood and adolescence. 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Cochrane Database Syst Rev. 2015;2015(8):004464.","journal-title":"Cochrane Database Syst Rev"},{"issue":"3","key":"8052_CR8","doi-asserted-by":"publisher","first-page":"467","DOI":"10.51821\/84.3.012","volume":"84","author":"N Pauwels","year":"2021","unstructured":"Pauwels N, Willemse C, Hellemans S, Komen N, Van den Broeck S, Roenen J, Van Aggelpoel T, De Schepper H. The role of neuromodulation in chronic functional constipation: a systematic review. Acta Gastroenterol Belg. 2021;84(3):467\u201376.","journal-title":"Acta Gastroenterol Belg"},{"issue":"6","key":"8052_CR9","doi-asserted-by":"publisher","first-page":"559","DOI":"10.1007\/s10151-019-02011-z","volume":"23","author":"S Gortazar de Las Casas","year":"2019","unstructured":"Gortazar de Las Casas S, Rubio-P\u00e9rez I, Saavedra Ambrosy J, Sancho de Avila A, \u00c1lvarez-Gallego M, Marijuan Mart\u00edn JL, Pascual Miguela\u00f1ez I. Sacral nerve stimulation for constipation: long-term outcomes. Tech Coloproctol. 2019;23(6):559\u201364.","journal-title":"Tech Coloproctol"},{"issue":"3","key":"8052_CR10","doi-asserted-by":"publisher","first-page":"347","DOI":"10.1097\/MOP.0000000000000486","volume":"29","author":"ML Westfal","year":"2017","unstructured":"Westfal ML, Goldstein AM. Pediatric enteric neuropathies: diagnosis and current management. Curr Opin Pediatr. 2017;29(3):347\u201353.","journal-title":"Curr Opin Pediatr"},{"key":"8052_CR11","doi-asserted-by":"crossref","unstructured":"Diez S, Kirchgatter A, Adam D, F\u00fcldner A, M\u00fcller H, Matzel KE, et al. Noninvasive Sacral Neuromodulation in Children and Adolescents: A Case-Control Study of Patients With Chronic Refractory Constipation. 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If protocol modifications are required, amendments will be submitted to and approved by the local ethics committee. Written, informed consent to participate will be obtained from all participants each subject and next-of-kin by the investigators before the subject enters the trial.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Written informed consent for publication is obtained by all presented subjects and next-of-kin.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors declare that they have no competing interests.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"210"}}