{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,21]],"date-time":"2026-08-21T05:23:33Z","timestamp":1787289813048,"version":"build-2736575974"},"reference-count":41,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2026,8,21]],"date-time":"2026-08-21T00:00:00Z","timestamp":1787270400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Neurol."],"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Neurogenic bowel dysfunction is a consequence of almost all spinal injuries. Primary management is via conservative treatment methods with few intermediary interventions available prior to surgical management. This protocol describes a trial to determine if genital nerve stimulation (GNS) can reliably be delivered at-home for the purpose of modulating neurogenic bowel dysfunction in people living with spinal cord injury (SCI).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>A total of 12 participants, aged 18\u202fyears or older with any severity of a traumatic SCI (at least 6\u202fmonths post-injury) at or above the neurological level of T12 with severe neurogenic bowel dysfunction will be enrolled, randomized, and perform GNS or sham stimulation 6\u20138\u202fh per day for 4\u202fweeks. Daily bowel and stimulation diaries will be filled out by participants or caregivers to provide qualitative and feasibility data. Anorectal manometry (ARM) assessments will be performed at Baseline (before stimulation), at the End of Treatment (the next day after cessation of at-home stimulation), and at the End of Study (after 2\u202fweeks of no stimulation). ARM assessments provide quantitative data for changes in anal sphincter and rectal function due to stimulation. Self-report questionnaires will be completed at each ARM assessment regarding neurogenic bowel dysfunction and impacts of bowel function on quality of life.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Discussion<\/jats:title>\n                    <jats:p>Outputs from this trial will inform research and clinical practice on the preliminary neuromodulatory effects of GNS on SCI-induced neurogenic bowel dysfunction and will guide the development of a properly powered efficacy trial testing GNS as an intermediary intervention.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>The study was approved by the MetroHealth Institutional Review Board (STUDY00000717) and registered at clinicaltrials.gov prior to enrollment of participants. Dissemination of results will be through presentations at academic meetings and in the community, and peer-reviewed medical journals.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Clinical trial registration<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link>https:\/\/clinicaltrials.gov\/study\/NCT06836739<\/jats:ext-link>\n                      , identifier NCT06836739.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.3389\/fneur.2026.1922192","type":"journal-article","created":{"date-parts":[[2026,8,21]],"date-time":"2026-08-21T04:23:43Z","timestamp":1787286223000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":0,"title":["At-home feasibility trial of genital nerve stimulation to modulate neurogenic bowel dysfunction in individuals living with spinal cord injury: a protocol"],"prefix":"10.3389","volume":"17","author":[{"given":"Robert","family":"Hoey","sequence":"first","affiliation":[{"name":"MetroHealth System | Case Western Reserve University School of Medicine, Department of Physical Medicine and Rehabilitation","place":["Cleveland, OH, United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amy","family":"Binko","sequence":"additional","affiliation":[{"name":"MetroHealth System | Case Western Reserve University School of Medicine, Department of Physical Medicine and Rehabilitation","place":["Cleveland, OH, United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dennis","family":"Bourbeau","sequence":"additional","affiliation":[{"name":"MetroHealth System | Case Western Reserve University School of Medicine, Department of Physical Medicine and Rehabilitation","place":["Cleveland, OH, United States"]},{"name":"Veteran Affairs Northeast Ohio Health System","place":["Cleveland, OH, United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ronnie","family":"Fass","sequence":"additional","affiliation":[{"name":"MetroHealth System | Case Western Reserve University School of Medicine, Department of Gastroenterology and Hepatology","place":["Cleveland, OH, United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Doug","family":"Gunzler","sequence":"additional","affiliation":[{"name":"MetroHealth System | Case Western Reserve University School of Medicine, Department of Medicine","place":["Cleveland, OH, United States"]},{"name":"Department of Population and Quantitative Health Sciences, Case Western Reserve University School of Medicine","place":["Cleveland, OH, United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laney","family":"Korty","sequence":"additional","affiliation":[{"name":"MetroHealth System | Case Western Reserve University School of Medicine, Department of Physical Medicine and Rehabilitation","place":["Cleveland, OH, United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anvi","family":"Kshirsagar","sequence":"additional","affiliation":[{"name":"MetroHealth System | Case Western Reserve University School of Medicine, Department of Physical Medicine and Rehabilitation","place":["Cleveland, OH, United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mayson","family":"Moore","sequence":"additional","affiliation":[{"name":"MetroHealth System | Case Western Reserve University School of Medicine, Department of Physical Medicine and Rehabilitation","place":["Cleveland, OH, United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Megan","family":"Moynahan","sequence":"additional","affiliation":[{"name":"MetroHealth System | Case Western Reserve University School of Medicine, Department of Physical Medicine and Rehabilitation","place":["Cleveland, OH, United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Megan Hammond","family":"Nechols","sequence":"additional","affiliation":[{"name":"MetroHealth System | Case Western Reserve University School of Medicine, Department of Physical Medicine and Rehabilitation","place":["Cleveland, OH, United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Benjamin","family":"Petrie","sequence":"additional","affiliation":[{"name":"MetroHealth System | Case Western Reserve University School of Medicine, Department of Physical Medicine and Rehabilitation","place":["Cleveland, OH, United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ed","family":"Stitts","sequence":"additional","affiliation":[{"name":"MetroHealth System | Case Western Reserve University School of Medicine, Department of Physical Medicine and Rehabilitation","place":["Cleveland, OH, United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James","family":"Wilson","sequence":"additional","affiliation":[{"name":"Kessler Institute for Rehabilitation","place":["West Orange, NJ, United States"]},{"name":"Department of Physical Medicine and Rehabilitation, Rutgers New Jersey Medical School","place":["Newark, NJ, United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kimberly D","family":"Anderson","sequence":"additional","affiliation":[{"name":"MetroHealth System | Case Western Reserve University School of Medicine, Department of Physical Medicine and Rehabilitation","place":["Cleveland, OH, United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2026,8,21]]},"reference":[{"key":"ref1","volume-title":"Traumatic Spinal Cord Injury Facts and Figures at a Glance","year":"2026"},{"key":"ref2","doi-asserted-by":"publisher","first-page":"495","DOI":"10.1038\/s41393-024-01002-8","article-title":"Bowel burdens: a systematic review and meta-analysis examining the relationships between bowel dysfunction and quality of life after spinal cord injury","volume":"62","author":"Sober-Williams","year":"2024","journal-title":"Spinal Cord"},{"key":"ref3","doi-asserted-by":"publisher","first-page":"1800","DOI":"10.12688\/f1000research.20529.1","article-title":"Neurogenic bowel dysfunction","volume":"8","author":"Emmanuel","year":"2019","journal-title":"F1000Res"},{"key":"ref4","doi-asserted-by":"publisher","first-page":"193","DOI":"10.1038\/sj.sc.3101119","article-title":"Bowel dysfunction following spinal cord injury","volume":"39","author":"Lynch","year":"2001","journal-title":"Spinal Cord"},{"key":"ref5","doi-asserted-by":"publisher","first-page":"1371","DOI":"10.1089\/neu.2004.21.1371","article-title":"Targeting recovery: priorities of the spinal cord\u2013injured population","volume":"21","author":"Anderson","year":"2004","journal-title":"J Neurotrauma"},{"key":"ref6","doi-asserted-by":"publisher","first-page":"323","DOI":"10.1038\/sc.2008.137","article-title":"Management of neurogenic bowel dysfunction in the community after spinal cord injury: a postal survey","volume":"47","author":"Coggrave","year":"2009","journal-title":"Spinal Cord"},{"key":"ref7","doi-asserted-by":"publisher","first-page":"718","DOI":"10.1038\/sc.2010.14","article-title":"Neurogenic bowel management after spinal cord injury: a systematic review of the evidence","volume":"48","author":"Krassioukov","year":"2010","journal-title":"Spinal Cord"},{"key":"ref8","doi-asserted-by":"publisher","first-page":"531","DOI":"10.1016\/j.bpg.2009.04.012","article-title":"Neurogenic colorectal and pelvic floor dysfunction","volume":"23","author":"Krogh","year":"2009","journal-title":"Best Pract Res Clin Gastroenterol"},{"key":"ref9","doi-asserted-by":"publisher","first-page":"1233","DOI":"10.1007\/BF02055170","article-title":"Colorectal function in patients with spinal cord lesions","volume":"40","author":"Krogh","year":"1997","journal-title":"Dis Colon Rectum"},{"key":"ref10","doi-asserted-by":"publisher","first-page":"75","DOI":"10.46292\/sci2702-75","article-title":"Management of neurogenic bowel dysfunction in adults after spinal cord injury: clinical practice guidelines for health care providers","volume":"27","author":"Johns","year":"","journal-title":"Top Spinal Cord Inj Rehabil"},{"key":"ref11","doi-asserted-by":"publisher","first-page":"383","DOI":"10.1038\/s41393-023-00874-6","article-title":"Causes and length of stay of readmission among individuals with traumatic spinal cord injury: a prospective observational cohort study","volume":"61","author":"Franceschini","year":"2023","journal-title":"Spinal Cord"},{"key":"ref12","doi-asserted-by":"publisher","first-page":"910","DOI":"10.1016\/j.cgh.2010.06.004","article-title":"Advances in diagnostic assessment of fecal incontinence and dyssynergic defecation","volume":"8","author":"Rao","year":"2010","journal-title":"Clin Gastroenterol Hepatol"},{"key":"ref13","doi-asserted-by":"publisher","first-page":"1651","DOI":"10.1016\/s0140-6736(96)91487-7","article-title":"Bowel dysfunction in spinal-cord-injury patients","volume":"347","author":"Glickman","year":"1996","journal-title":"Lancet"},{"key":"ref14","doi-asserted-by":"publisher","first-page":"738","DOI":"10.1053\/j.gastro.2006.06.004","article-title":"A randomized, controlled trial of transanal irrigation versus conservative bowel management in spinal cord\u2013injured patients","volume":"131","author":"Christensen","year":"2006","journal-title":"Gastroenterology"},{"key":"ref15","doi-asserted-by":"publisher","first-page":"2155","DOI":"10.1111\/codi.15273","article-title":"Effect of sacral neuromodulation on bowel dysfunction in patients with neurogenic bladder","volume":"22","author":"Chen","year":"2020","journal-title":"Color Dis"},{"key":"ref16","doi-asserted-by":"publisher","first-page":"115","DOI":"10.1007\/s10151-007-0340-3","article-title":"Posterior tibial nerve stimulation for faecal incontinence after partial spinal injury: preliminary report","volume":"11","author":"Mentes","year":"2007","journal-title":"Tech Coloproctol"},{"key":"ref17","doi-asserted-by":"publisher","first-page":"360","DOI":"10.1080\/10790268.2017.1422881","article-title":"At-home genital nerve stimulation for individuals with SCI and neurogenic detrusor overactivity: a pilot feasibility study","volume":"42","author":"Bourbeau","year":"2019","journal-title":"J Spinal Cord Med"},{"key":"ref18","doi-asserted-by":"publisher","first-page":"109","DOI":"10.1016\/j.expneurol.2010.12.016","article-title":"Plasticity of urinary bladder reflexes evoked by stimulation of pudendal afferent nerves after chronic spinal cord injury in cats","volume":"228","author":"Tai","year":"2011","journal-title":"Exp Neurol"},{"key":"ref19","doi-asserted-by":"publisher","first-page":"358","DOI":"10.1002\/nau.22453","article-title":"Pudendal nerve stimulation: a potential tool for neurogenic bowel dysfunction!","volume":"33","author":"Calabr\u00f2","year":"2014","journal-title":"Neurourol Urodyn"},{"key":"ref20","doi-asserted-by":"publisher","first-page":"1134","DOI":"10.1097\/DCR.0b013e318220c0ba","article-title":"Temporary sacral nerve stimulation alters rectal sensory function: a physiological study","volume":"54","author":"Abdel-Halim","year":"2011","journal-title":"Dis Colon Rectum"},{"key":"ref21","doi-asserted-by":"publisher","first-page":"462","DOI":"10.1038\/sc.2011.159","article-title":"Acute effect of electrical stimulation of the dorsal genital nerve on rectal capacity in patients with spinal cord injury","volume":"50","author":"Wors\u00f8e","year":"2012","journal-title":"Spinal Cord"},{"key":"ref22","doi-asserted-by":"publisher","first-page":"459","DOI":"10.1007\/s10151-023-02752-y","article-title":"Electrical stimulation of the dorsal clitoral nerve in the treatment of idiopathic defecatory urgency. A pilot study","volume":"27","author":"Qvist","year":"2023","journal-title":"Tech Coloproctol"},{"key":"ref23","doi-asserted-by":"publisher","first-page":"349","DOI":"10.1111\/j.1463-1318.2011.02586.x","article-title":"Electrical stimulation of the dorsal clitoral nerve reduces incontinence episodes in idiopathic faecal incontinent patients: a pilot study","volume":"14","author":"Wors\u00f8e","year":"2012","journal-title":"Color Dis"},{"key":"ref24","doi-asserted-by":"publisher","first-page":"e70225","DOI":"10.1111\/nmo.70225","article-title":"Dorsal genital nerve stimulation in patients with fecal incontinence and fecal urgency: a feasibility study with the novel UCon neurostimulator","volume":"38","author":"Grau","year":"2026","journal-title":"Neurogastroenterol Motil"},{"key":"ref25","doi-asserted-by":"publisher","first-page":"403","DOI":"10.1177\/15533506261415996","article-title":"Assessment of dorsal genital nerve stimulation for fecal incontinence: a systematic review and meta-analysis","volume":"33","author":"Christodoulou","year":"2026","journal-title":"Surg Innov"},{"key":"ref26","doi-asserted-by":"publisher","first-page":"625","DOI":"10.1038\/sj.sc.3101887","article-title":"Neurogenic bowel dysfunction score","volume":"44","author":"Krogh","year":"2006","journal-title":"Spinal Cord"},{"key":"ref27","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1186\/1471-2288-10-1","article-title":"A tutorial on pilot studies: the what, why and how","volume":"10","author":"Thabane","year":"2010","journal-title":"BMC Med Res Methodol"},{"key":"ref28","doi-asserted-by":"publisher","first-page":"153","DOI":"10.2147\/CLEP.S146397","article-title":"Guidance for using pilot studies to inform the design of intervention trials with continuous outcomes","volume":"10","author":"Bell","year":"2018","journal-title":"Clin Epidemiol"},{"key":"ref29","doi-asserted-by":"publisher","first-page":"1933","DOI":"10.1002\/sim.4780141709","article-title":"On the use of a pilot sample for sample size determination","volume":"14","author":"Browne","year":"1995","journal-title":"Stat Med"},{"key":"ref30","doi-asserted-by":"publisher","first-page":"287","DOI":"10.1002\/pst.185","article-title":"Sample size of 12 per group rule of thumb for a pilot study","volume":"4","author":"Julious","year":"2005","journal-title":"Pharm Stat"},{"key":"ref31","doi-asserted-by":"publisher","first-page":"174","DOI":"10.1080\/10790268.2017.1279817","article-title":"Genital nerve stimulation is tolerable and effective for bladder inhibition in sensate individuals with incomplete SCI","volume":"41","author":"Brose","year":"2018","journal-title":"J Spinal Cord Med"},{"key":"ref32","doi-asserted-by":"publisher","first-page":"1421","DOI":"10.1002\/(SICI)1097-0258(19960715)15:13<1421::AID-SIM266>3.0.CO;2-H","article-title":"An index for assessing blindness in a multi-centre clinical trial: disulfiram for alcohol cessation\u2014a VA cooperative study","volume":"15","author":"James","year":"1996","journal-title":"Stat Med"},{"key":"ref33","doi-asserted-by":"publisher","first-page":"437","DOI":"10.5056\/jnm.2010.16.4.437","article-title":"How to interpret conventional anorectal manometry","volume":"16","author":"Kim","year":"2010","journal-title":"J Neuro-Oncol"},{"key":"ref34","doi-asserted-by":"publisher","first-page":"e13679","DOI":"10.1111\/nmo.13679","article-title":"The international anorectal physiology working group (IAPWG) recommendations: standardized testing protocol and the London classification for disorders of anorectal function","volume":"32","author":"Carrington","year":"2020","journal-title":"Neurogastroenterol Motil"},{"key":"ref35","doi-asserted-by":"publisher","first-page":"319","DOI":"10.1016\/j.pmr.2020.03.005","article-title":"International standards committee of ASIA and ISCoS. Updates of the international standards for neurologic classification of spinal cord injury: 2015 and 2019","volume":"31","author":"Kirshblum","year":"2020","journal-title":"Phys Med Rehabil Clin N Am"},{"key":"ref36","doi-asserted-by":"publisher","first-page":"63","DOI":"10.1038\/s41394-019-0210-z","article-title":"Version 2.1 of the international spinal cord injury bowel function basic data set","volume":"5","author":"Krogh","year":"","journal-title":"Spinal Cord Ser Cases"},{"key":"ref37","doi-asserted-by":"publisher","first-page":"553","DOI":"10.1016\/j.purol.2016.06.008","article-title":"Neurogenic bowel dysfunction (NBD) translation and linguistic validation to classical Arabic","volume":"26","author":"Mallek","year":"2016","journal-title":"Prog Urol"},{"key":"ref38","doi-asserted-by":"publisher","first-page":"1084","DOI":"10.1038\/sc.2017.82","article-title":"Reliability, validity and sensitivity to change of neurogenic bowel dysfunction score in patients with spinal cord injury","volume":"55","author":"Erdem","year":"2017","journal-title":"Spinal Cord"},{"key":"ref39","doi-asserted-by":"publisher","first-page":"288","DOI":"10.1179\/2045772315Y.0000000030","article-title":"Development and psychometric characteristics of the SCI-QOL bladder management difficulties and bowel management difficulties item banks and short forms and the SCI-QOL bladder complications scale","volume":"38","author":"Tulsky","year":"2015","journal-title":"J Spinal Cord Med"},{"key":"ref40","doi-asserted-by":"publisher","first-page":"920","DOI":"10.3109\/00365529709011203","article-title":"Stool form scale as a useful guide to intestinal transit time","volume":"32","author":"Lewis","year":"1997","journal-title":"Scand J Gastroenterol"},{"key":"ref41","doi-asserted-by":"publisher","first-page":"141","DOI":"10.1080\/10790268.2019.1706033","article-title":"Recommendations for evaluation of neurogenic bladder and bowel dysfunction after spinal cord injury and\/or disease","volume":"43","author":"Tate","year":"2020","journal-title":"J Spinal Cord Med"}],"container-title":["Frontiers in Neurology"],"original-title":[],"link":[{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fneur.2026.1922192\/full","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,21]],"date-time":"2026-08-21T04:23:44Z","timestamp":1787286224000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fneur.2026.1922192\/full"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,8,21]]},"references-count":41,"alternative-id":["10.3389\/fneur.2026.1922192"],"URL":"https:\/\/doi.org\/10.3389\/fneur.2026.1922192","relation":{},"ISSN":["1664-2295"],"issn-type":[{"value":"1664-2295","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,8,21]]},"article-number":"1922192"}}