{"id":"https://openalex.org/W7225453080","doi":"https://doi.org/10.1186/s13063-026-10068-z","title":"Efficacy of sacral neuromodulation versus placebo in patients with multiple sclerosis with neurogenic lower urinary tract, bowel, and sexual dysfunction: study protocol for a multicenter randomized placebo-controlled trial","display_name":"Efficacy of sacral neuromodulation versus placebo in patients with multiple sclerosis with neurogenic lower urinary tract, bowel, and sexual dysfunction: study protocol for a multicenter randomized placebo-controlled trial","publication_year":2026,"publication_date":"2026-11-07","ids":{"openalex":"https://openalex.org/W7225453080","doi":"https://doi.org/10.1186/s13063-026-10068-z"},"language":"en","primary_location":{"id":"doi:10.1186/s13063-026-10068-z","doi":"https://doi.org/10.1186/s13063-026-10068-z","is_oa":true,"landing_page_url":"https://doi.org/10.1186/s13063-026-10068-z","pdf_url":null,"source":{"id":"https://openalex.org/S109512841","display_name":"Trials","issn_l":"1745-6215","issn":["1745-6215"],"is_oa":true,"is_in_doaj":true,"is_core":true,"listed_in":["anvur-class-a","anvur-scientific","cwts-core","doaj","dongbi-b","doyens","jufo-1","ki-jl-1","medline","norway-1","oarl","poland-100","russia-white-list-2","vabb-shw"],"host_organization":"https://openalex.org/P4310319900","host_organization_name":"Springer Science+Business Media","host_organization_lineage":["https://openalex.org/P4310319900","https://openalex.org/P4310319965"],"host_organization_lineage_names":["Springer Science+Business Media","Springer Nature"],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Trials","raw_type":"journal-article"},"volume":null,"type":"article","is_traditional":true,"indexed_in":["crossref","doaj"],"open_access":{"is_oa":true,"oa_status":"gold","oa_url":"https://doi.org/10.1186/s13063-026-10068-z","any_repository_has_fulltext":false},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5065351672","display_name":"Hanne Kobber\u00f8","orcid":"https://orcid.org/0000-0003-2847-6257","observed_orcids":["https://orcid.org/0000-0003-2847-6257"]},"institutions":[{"id":"https://openalex.org/I177969490","display_name":"University of Southern Denmark","ror":"https://ror.org/03yrrjy16","country_code":"DK","type":"education","lineage":["https://openalex.org/I177969490"]},{"id":"https://openalex.org/I2801498763","display_name":"Odense University Hospital","ror":"https://ror.org/00ey0ed83","country_code":"DK","type":"healthcare","lineage":["https://openalex.org/I2801498763"]}],"countries":["DK"],"is_corresponding":true,"raw_author_name":"Hanne Kobber\u00f8","raw_affiliation_strings":["Department of Regional Health Research, University of Southern Denmark, Odense, Denmark","Department of Urology, Odense University Hospital, Odense, Denmark"],"raw_orcid":"https://orcid.org/0000-0003-2847-6257","affiliations":[{"raw_affiliation_string":"Department of Regional Health Research, University of Southern Denmark, Odense, Denmark","institution_ids":["https://openalex.org/I177969490"]},{"raw_affiliation_string":"Department of Urology, Odense University Hospital, Odense, Denmark","institution_ids":["https://openalex.org/I2801498763"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5082396504","display_name":"Jan Krh\u00fat","orcid":"https://orcid.org/0000-0003-4205-5926","observed_orcids":["https://orcid.org/0000-0003-4205-5926"]},"institutions":[{"id":"https://openalex.org/I187293425","display_name":"University of Ostrava","ror":"https://ror.org/00pyqav47","country_code":"CZ","type":"education","lineage":["https://openalex.org/I187293425"]},{"id":"https://openalex.org/I4210088935","display_name":"University Hospital Ostrava","ror":"https://ror.org/00a6yph09","country_code":"CZ","type":"healthcare","lineage":["https://openalex.org/I4210088935"]}],"countries":["CZ"],"is_corresponding":false,"raw_author_name":"Jan Krhut","raw_affiliation_strings":["Department of Surgical Studies, Ostrava University, Ostrava, Czech Republic","Department of Urology, University Hospital, Ostrava, Czech Republic"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Surgical Studies, Ostrava University, Ostrava, Czech Republic","institution_ids":["https://openalex.org/I187293425"]},{"raw_affiliation_string":"Department of Urology, University Hospital, Ostrava, Czech Republic","institution_ids":["https://openalex.org/I4210088935"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5048061827","display_name":"Peter Zvara","orcid":"https://orcid.org/0000-0002-6972-6980","observed_orcids":["https://orcid.org/0000-0002-6972-6980"]},"institutions":[{"id":"https://openalex.org/I177969490","display_name":"University of Southern Denmark","ror":"https://ror.org/03yrrjy16","country_code":"DK","type":"education","lineage":["https://openalex.org/I177969490"]},{"id":"https://openalex.org/I2801498763","display_name":"Odense University Hospital","ror":"https://ror.org/00ey0ed83","country_code":"DK","type":"healthcare","lineage":["https://openalex.org/I2801498763"]}],"countries":["DK"],"is_corresponding":false,"raw_author_name":"Peter Zvara","raw_affiliation_strings":["Department of Clinical Research, Research Unit of Urology, University of Southern Denmark, Odense, Denmark","Department of Urology, Odense University Hospital, Odense, Denmark"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Clinical Research, Research Unit of Urology, University of Southern Denmark, Odense, Denmark","institution_ids":["https://openalex.org/I177969490"]},{"raw_affiliation_string":"Department of Urology, Odense University Hospital, Odense, Denmark","institution_ids":["https://openalex.org/I2801498763"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5079018568","display_name":"Mikkel Mejlgaard Fode","orcid":"https://orcid.org/0000-0002-8963-4581","observed_orcids":["https://orcid.org/0000-0002-8963-4581"]},"institutions":[{"id":"https://openalex.org/I124055696","display_name":"University of Copenhagen","ror":"https://ror.org/035b05819","country_code":"DK","type":"education","lineage":["https://openalex.org/I124055696"]},{"id":"https://openalex.org/I2801827564","display_name":"Herlev Hospital","ror":"https://ror.org/00wys9y90","country_code":"DK","type":"healthcare","lineage":["https://openalex.org/I2801827564","https://openalex.org/I2802567020"]},{"id":"https://openalex.org/I2802567020","display_name":"Copenhagen University Hospital","ror":"https://ror.org/05bpbnx46","country_code":"DK","type":"healthcare","lineage":["https://openalex.org/I2802567020"]},{"id":"https://openalex.org/I2802582725","display_name":"Gentofte Hospital","ror":"https://ror.org/051dzw862","country_code":"DK","type":"healthcare","lineage":["https://openalex.org/I2802567020","https://openalex.org/I2802582725"]}],"countries":["DK"],"is_corresponding":false,"raw_author_name":"Mikkel Fode","raw_affiliation_strings":["Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark","Department of Urology, Copenhagen University Hospital \u2010 Herlev and Gentofte Hospital, Herlev, Denmark"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark","institution_ids":["https://openalex.org/I124055696"]},{"raw_affiliation_string":"Department of Urology, Copenhagen University Hospital \u2010 Herlev and Gentofte Hospital, Herlev, Denmark","institution_ids":["https://openalex.org/I2801827564","https://openalex.org/I2802567020","https://openalex.org/I2802582725"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5006636155","display_name":"Anna Mejldal","orcid":"https://orcid.org/0000-0002-4612-4338","observed_orcids":["https://orcid.org/0000-0002-4612-4338"]},"institutions":[{"id":"https://openalex.org/I177969490","display_name":"University of Southern Denmark","ror":"https://ror.org/03yrrjy16","country_code":"DK","type":"education","lineage":["https://openalex.org/I177969490"]},{"id":"https://openalex.org/I2801498763","display_name":"Odense University Hospital","ror":"https://ror.org/00ey0ed83","country_code":"DK","type":"healthcare","lineage":["https://openalex.org/I2801498763"]}],"countries":["DK"],"is_corresponding":false,"raw_author_name":"Anna Mejldal","raw_affiliation_strings":["Department of Clinical Research, Research Unit of Psychiatry, University of Southern Denmark, Odense, Denmark","Open Patient Data Explorative Network, Odense University Hospital, Odense, Denmark"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Clinical Research, Research Unit of Psychiatry, University of Southern Denmark, Odense, Denmark","institution_ids":["https://openalex.org/I177969490"]},{"raw_affiliation_string":"Open Patient Data Explorative Network, Odense University Hospital, Odense, Denmark","institution_ids":["https://openalex.org/I2801498763"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5078984917","display_name":"Helle Hvilsted Nielsen","orcid":"https://orcid.org/0000-0002-7319-1368","observed_orcids":["https://orcid.org/0000-0002-7319-1368"]},"institutions":[{"id":"https://openalex.org/I177969490","display_name":"University of Southern Denmark","ror":"https://ror.org/03yrrjy16","country_code":"DK","type":"education","lineage":["https://openalex.org/I177969490"]},{"id":"https://openalex.org/I2801498763","display_name":"Odense University Hospital","ror":"https://ror.org/00ey0ed83","country_code":"DK","type":"healthcare","lineage":["https://openalex.org/I2801498763"]}],"countries":["DK"],"is_corresponding":false,"raw_author_name":"Helle Hvilsted Nielsen","raw_affiliation_strings":["BRIDGE \u2013 Brain Research \u2013 Inter Disciplinary Guided Excellence, University of Southern Denmark, Odense, Denmark","Department of Neurology, Odense University Hospital, Odense, Denmark","Neurobiology Research, Institute of Molecular Medicine, University of Southern Denmark, Odense, Denmark"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"BRIDGE \u2013 Brain Research \u2013 Inter Disciplinary Guided Excellence, University of Southern Denmark, Odense, Denmark","institution_ids":["https://openalex.org/I177969490"]},{"raw_affiliation_string":"Department of Neurology, Odense University Hospital, Odense, Denmark","institution_ids":["https://openalex.org/I2801498763"]},{"raw_affiliation_string":"Neurobiology Research, Institute of Molecular Medicine, University of Southern Denmark, Odense, Denmark","institution_ids":["https://openalex.org/I177969490"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5161247461","display_name":"Morten Blaaberg","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I177969490","display_name":"University of Southern Denmark","ror":"https://ror.org/03yrrjy16","country_code":"DK","type":"education","lineage":["https://openalex.org/I177969490"]},{"id":"https://openalex.org/I2801498763","display_name":"Odense University Hospital","ror":"https://ror.org/00ey0ed83","country_code":"DK","type":"healthcare","lineage":["https://openalex.org/I2801498763"]}],"countries":["DK"],"is_corresponding":false,"raw_author_name":"Morten Blaaberg","raw_affiliation_strings":["Department of Clinical Research, Research Unit of Neurology, University of Southern Denmark, Odense, Denmark","Department of Neurology, Odense University Hospital, Odense, Denmark"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Clinical Research, Research Unit of Neurology, University of Southern Denmark, Odense, Denmark","institution_ids":["https://openalex.org/I177969490"]},{"raw_affiliation_string":"Department of Neurology, Odense University Hospital, Odense, Denmark","institution_ids":["https://openalex.org/I2801498763"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5020428768","display_name":"Mads Hvid Poulsen","orcid":"https://orcid.org/0000-0002-7622-8402","observed_orcids":["https://orcid.org/0000-0002-7622-8402"]},"institutions":[{"id":"https://openalex.org/I177969490","display_name":"University of Southern Denmark","ror":"https://ror.org/03yrrjy16","country_code":"DK","type":"education","lineage":["https://openalex.org/I177969490"]},{"id":"https://openalex.org/I4210134581","display_name":"Hospital South West Jutland","ror":"https://ror.org/03pzgk858","country_code":"DK","type":"healthcare","lineage":["https://openalex.org/I4210134581"]}],"countries":["DK"],"is_corresponding":false,"raw_author_name":"Mads Hvid Poulsen","raw_affiliation_strings":["Department of Regional Health Research, University of Southern Denmark, Odense, Denmark","Department of Urology, Esbjerg and Grindsted Hospital, University Hospital of Southern Denmark, Esbjerg, Denmark"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Regional Health Research, University of Southern Denmark, Odense, Denmark","institution_ids":["https://openalex.org/I177969490"]},{"raw_affiliation_string":"Department of Urology, Esbjerg and Grindsted Hospital, University Hospital of Southern Denmark, Esbjerg, Denmark","institution_ids":["https://openalex.org/I4210134581"]}]}],"institutions":[],"countries_distinct_count":2,"institutions_distinct_count":9,"corresponding_author_ids":["https://openalex.org/A5065351672"],"corresponding_institution_ids":["https://openalex.org/I177969490","https://openalex.org/I2801498763"],"apc_list":{"value":2790,"currency":"USD","value_usd":2790},"apc_paid":{"value":2790,"currency":"USD","value_usd":2790},"fwci":0.0,"has_fulltext":false,"cited_by_count":0,"citation_normalized_percentile":{"value":0.0,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":null,"biblio":{"volume":null,"issue":null,"first_page":null,"last_page":null},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T10279","display_name":"Urinary Bladder and Prostate Research","score":0.9976000189781189,"subfield":{"id":"https://openalex.org/subfields/2748","display_name":"Urology"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},"topics":[{"id":"https://openalex.org/T10279","display_name":"Urinary Bladder and Prostate Research","score":0.9976000189781189,"subfield":{"id":"https://openalex.org/subfields/2748","display_name":"Urology"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T10418","display_name":"Pelvic floor disorders treatments","score":0.0008999999845400453,"subfield":{"id":"https://openalex.org/subfields/2748","display_name":"Urology"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T11232","display_name":"Urinary Tract Infections Management","score":0.00019999999494757503,"subfield":{"id":"https://openalex.org/subfields/2748","display_name":"Urology"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/sacral-neuromodulation","display_name":"sacral neuromodulation","score":0.9110000133514404},{"id":"https://openalex.org/keywords/multiple-sclerosis","display_name":"multiple sclerosis","score":0.9980000257492065},{"id":"https://openalex.org/keywords/neurogenic-bladder","display_name":"neurogenic bladder","score":0.9950000047683716},{"id":"https://openalex.org/keywords/neurogenic-bowel-dysfunction","display_name":"neurogenic bowel dysfunction","score":0.9330000281333923},{"id":"https://openalex.org/keywords/neurogenic-sexual-dysfunction","display_name":"neurogenic sexual dysfunction","score":0.9800000190734863},{"id":"https://openalex.org/keywords/implantable-pulse-generator","display_name":"implantable pulse generator","score":0.8130000233650208},{"id":"https://openalex.org/keywords/bladder-diary","display_name":"bladder diary","score":0.47200000286102295},{"id":"https://openalex.org/keywords/urodynamics","display_name":"urodynamics","score":0.6650000214576721},{"id":"https://openalex.org/keywords/health-related-quality-of-life","display_name":"health-related quality of life","score":0.8370000123977661},{"id":"https://openalex.org/keywords/treatment-satisfaction","display_name":"treatment satisfaction","score":0.8450000286102295},{"id":"https://openalex.org/keywords/patient-selection-criteria","display_name":"patient selection criteria","score":0.5680000185966492},{"id":"https://openalex.org/keywords/stimulation-parameters","display_name":"stimulation parameters","score":0.4580000042915344},{"id":"https://openalex.org/keywords/safety-and-tolerability","display_name":"safety and tolerability","score":0.5400000214576721},{"id":"https://openalex.org/keywords/patient-reported-outcomes","display_name":"patient-reported outcomes","score":0.3490000069141388}],"concepts":[{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.934499979019165},{"id":"https://openalex.org/C27081682","wikidata":"https://www.wikidata.org/wiki/Q269829","display_name":"Placebo","level":3,"score":0.6944000124931335},{"id":"https://openalex.org/C168563851","wikidata":"https://www.wikidata.org/wiki/Q1436668","display_name":"Randomized controlled trial","level":2,"score":0.6654999852180481},{"id":"https://openalex.org/C204243189","wikidata":"https://www.wikidata.org/wiki/Q1363085","display_name":"Randomization","level":3,"score":0.6176000237464905},{"id":"https://openalex.org/C2771230","wikidata":"https://www.wikidata.org/wiki/Q4926699","display_name":"Blinding","level":3,"score":0.6062999963760376},{"id":"https://openalex.org/C2780640218","wikidata":"https://www.wikidata.org/wiki/Q8277","display_name":"Multiple sclerosis","level":2,"score":0.5403000116348267},{"id":"https://openalex.org/C2775871022","wikidata":"https://www.wikidata.org/wiki/Q7458776","display_name":"Sexual function","level":2,"score":0.5073999762535095},{"id":"https://openalex.org/C77411442","wikidata":"https://www.wikidata.org/wiki/Q181100","display_name":"Urinary system","level":2,"score":0.49390000104904175},{"id":"https://openalex.org/C2779951463","wikidata":"https://www.wikidata.org/wiki/Q7268788","display_name":"Quality of life (healthcare)","level":2,"score":0.4758000075817108},{"id":"https://openalex.org/C203092338","wikidata":"https://www.wikidata.org/wiki/Q1340863","display_name":"Clinical endpoint","level":3,"score":0.4235999882221222},{"id":"https://openalex.org/C535046627","wikidata":"https://www.wikidata.org/wiki/Q30612","display_name":"Clinical trial","level":2,"score":0.41519999504089355},{"id":"https://openalex.org/C2779478474","wikidata":"https://www.wikidata.org/wiki/Q446372","display_name":"Lower urinary tract symptoms","level":4,"score":0.40380001068115234},{"id":"https://openalex.org/C1862650","wikidata":"https://www.wikidata.org/wiki/Q186005","display_name":"Physical therapy","level":1,"score":0.40290001034736633},{"id":"https://openalex.org/C2778941218","wikidata":"https://www.wikidata.org/wiki/Q331231","display_name":"Overactive bladder","level":3,"score":0.3774000108242035},{"id":"https://openalex.org/C126894567","wikidata":"https://www.wikidata.org/wiki/Q105650","display_name":"Urology","level":1,"score":0.37389999628067017},{"id":"https://openalex.org/C142424586","wikidata":"https://www.wikidata.org/wiki/Q7307572","display_name":"Refractory (planetary science)","level":2,"score":0.36239999532699585},{"id":"https://openalex.org/C2776078848","wikidata":"https://www.wikidata.org/wiki/Q2339038","display_name":"Neurogenic bladder dysfunction","level":3,"score":0.32710000872612},{"id":"https://openalex.org/C126322002","wikidata":"https://www.wikidata.org/wiki/Q11180","display_name":"Internal medicine","level":1,"score":0.31049999594688416},{"id":"https://openalex.org/C2778093883","wikidata":"https://www.wikidata.org/wiki/Q1137463","display_name":"Sexual dysfunction","level":2,"score":0.30160000920295715},{"id":"https://openalex.org/C141071460","wikidata":"https://www.wikidata.org/wiki/Q40821","display_name":"Surgery","level":1,"score":0.29809999465942383},{"id":"https://openalex.org/C2780375056","wikidata":"https://www.wikidata.org/wiki/Q905905","display_name":"Neuromodulation","level":3,"score":0.2971000075340271},{"id":"https://openalex.org/C2779762690","wikidata":"https://www.wikidata.org/wiki/Q9382","display_name":"Urinary bladder","level":2,"score":0.2962000072002411},{"id":"https://openalex.org/C202953159","wikidata":"https://www.wikidata.org/wiki/Q382695","display_name":"Intention-to-treat analysis","level":3,"score":0.2800999879837036},{"id":"https://openalex.org/C2779384505","wikidata":"https://www.wikidata.org/wiki/Q17007513","display_name":"Concomitant","level":2,"score":0.2741999924182892},{"id":"https://openalex.org/C3017551082","wikidata":"https://www.wikidata.org/wiki/Q1863718","display_name":"Sacral nerve stimulation","level":2,"score":0.2680000066757202},{"id":"https://openalex.org/C30036603","wikidata":"https://www.wikidata.org/wiki/Q17125150","display_name":"Severity of illness","level":2,"score":0.26739999651908875},{"id":"https://openalex.org/C111278954","wikidata":"https://www.wikidata.org/wiki/Q17069312","display_name":"Minimal clinically important difference","level":3,"score":0.25760000944137573},{"id":"https://openalex.org/C205545832","wikidata":"https://www.wikidata.org/wiki/Q17156455","display_name":"Young adult","level":2,"score":0.2547000050544739},{"id":"https://openalex.org/C202061045","wikidata":"https://www.wikidata.org/wiki/Q7200267","display_name":"Placebo-controlled study","level":5,"score":0.2517000138759613},{"id":"https://openalex.org/C2780282741","wikidata":"https://www.wikidata.org/wiki/Q2275646","display_name":"Sexual medicine","level":2,"score":0.25}],"mesh":[],"locations_count":1,"locations":[{"id":"doi:10.1186/s13063-026-10068-z","doi":"https://doi.org/10.1186/s13063-026-10068-z","is_oa":true,"landing_page_url":"https://doi.org/10.1186/s13063-026-10068-z","pdf_url":null,"source":{"id":"https://openalex.org/S109512841","display_name":"Trials","issn_l":"1745-6215","issn":["1745-6215"],"is_oa":true,"is_in_doaj":true,"is_core":true,"listed_in":["anvur-class-a","anvur-scientific","cwts-core","doaj","dongbi-b","doyens","jufo-1","ki-jl-1","medline","norway-1","oarl","poland-100","russia-white-list-2","vabb-shw"],"host_organization":"https://openalex.org/P4310319900","host_organization_name":"Springer Science+Business Media","host_organization_lineage":["https://openalex.org/P4310319900","https://openalex.org/P4310319965"],"host_organization_lineage_names":["Springer Science+Business Media","Springer Nature"],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Trials","raw_type":"journal-article"}],"best_oa_location":{"id":"doi:10.1186/s13063-026-10068-z","doi":"https://doi.org/10.1186/s13063-026-10068-z","is_oa":true,"landing_page_url":"https://doi.org/10.1186/s13063-026-10068-z","pdf_url":null,"source":{"id":"https://openalex.org/S109512841","display_name":"Trials","issn_l":"1745-6215","issn":["1745-6215"],"is_oa":true,"is_in_doaj":true,"is_core":true,"listed_in":["anvur-class-a","anvur-scientific","cwts-core","doaj","dongbi-b","doyens","jufo-1","ki-jl-1","medline","norway-1","oarl","poland-100","russia-white-list-2","vabb-shw"],"host_organization":"https://openalex.org/P4310319900","host_organization_name":"Springer Science+Business Media","host_organization_lineage":["https://openalex.org/P4310319900","https://openalex.org/P4310319965"],"host_organization_lineage_names":["Springer Science+Business Media","Springer Nature"],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Trials","raw_type":"journal-article"},"sustainable_development_goals":[{"id":"https://metadata.un.org/sdg/3","display_name":"Good health and well-being","score":1.0}],"study_designs":[{"id":"https://openalex.org/study-designs/study-protocol","display_name":"Study Protocol"}],"awards":[],"funders":[{"id":"https://openalex.org/F4320323799","display_name":"Syddansk Universitet","ror":"https://ror.org/03yrrjy16"}],"has_content":{"pdf":false,"grobid_xml":false},"content_urls":null,"referenced_works_count":0,"referenced_works":[],"related_works":["https://openalex.org/W4409441013","https://openalex.org/W4412226414","https://openalex.org/W2180152924","https://openalex.org/W4407318774","https://openalex.org/W824341687","https://openalex.org/W4408412570","https://openalex.org/W4408098505","https://openalex.org/W2159607813","https://openalex.org/W7164201196","https://openalex.org/W2069414580"],"abstract_inverted_index":{"Abstract":[0],"Background":[1],"Multiple":[2],"sclerosis":[3],"(MS)":[4],"is":[5,18,116,153,159,173],"frequently":[6],"accompanied":[7],"by":[8,257,264],"neurogenic":[9],"lower":[10,335],"urinary":[11,24,336],"tract":[12,337],"dysfunction":[13],"(NLUTD).":[14],"Sacral":[15],"neuromodulation":[16],"(SNM)":[17,277],"a":[19,64,69,95,179,315],"guideline-endorsed":[20,59],"therapy":[21],"for":[22,112,303],"refractory":[23,57],"symptoms,":[25],"but":[26],"evidence":[27,311],"in":[28,80,164,198,225,314,331],"NLUTD":[29,56],"remains":[30],"limited.":[31],"We":[32],"aim":[33],"to":[34,58,103,154,301],"provide":[35,309],"robust":[36],"efficacy":[37],"data.":[38],"Methods":[39],"Since":[40],"August":[41],"2023,":[42],"this":[43,209],"multicenter,":[44],"placebo-controlled,":[45],"double-blind,":[46],"superiority,":[47],"randomized":[48,101,297],"trial":[49,307],"has":[50],"enrolled":[51],"adults":[52],"with":[53,68,178],"MS":[54,317],"and":[55,72,75,123,134,146,217,228,247,260,319,325],"therapies.":[60],"All":[61],"participants":[62,99,177],"undergo":[63],"1-month":[65,96],"test":[66],"phase":[67],"tined":[70],"lead":[71],"external":[73],"stimulator,":[74],"responders":[76],"(\u2265":[77],"50%":[78,194],"improvement":[79,167,195],"at":[81,127,144,147,182,199],"least":[82,200],"one":[83,201],"group-specific":[84,202],"bladder":[85,203],"diary":[86,204],"variable)":[87],"receive":[88],"an":[89],"implantable":[90],"pulse":[91],"generator":[92],"(IPG).":[93],"After":[94],"optimization":[97],"period,":[98],"are":[100,125,142,211,270,285],"1:1":[102],"active":[104],"(IPG":[105,109],"ON)":[106],"or":[107],"placebo":[108,163],"OFF)":[110],"treatment":[111,237],"4":[113,186],"months.":[114],"Blinding":[115],"maintained":[117],"through":[118],"subsensory":[119],"stimulation.":[120],"Bladder":[121],"diaries":[122],"questionnaires":[124],"collected":[126],"baseline,":[128],"post-test":[129],"phase,":[130],"after":[131,188],"optimization,":[132],"midterm,":[133],"study":[135,148],"end":[136],"(total":[137],"duration":[138],"6":[139],"months).":[140],"Urodynamics":[141],"performed":[143],"baseline":[145,197],"end.":[149],"The":[150,170,206,251],"primary":[151,171,252],"objective":[152],"determine":[155],"whether":[156],"continuous":[157,261],"SNM":[158,313,330],"more":[160],"effective":[161,248],"than":[162],"sustaining":[165],"symptom":[166],"over":[168],"time.":[169],"outcome":[172,253],"the":[174,214,327,332],"proportion":[175],"of":[176,234,275,329,334],"confirmed":[180],"response":[181,210],"randomization":[183,189],"(C)":[184],"who,":[185],"months":[187],"(E),":[190],"still":[191],"show":[192],"\u2265":[193],"from":[196],"variable.":[205],"proportions":[207],"maintaining":[208],"compared":[212],"between":[213],"IPG":[215,218],"ON":[216],"OFF":[219],"groups.":[220],"Secondary":[221],"outcomes":[222,263],"include":[223],"changes":[224],"bladder,":[226],"bowel,":[227],"sexual":[229],"function":[230],"(ICIQ),":[231],"health-related":[232],"quality":[233],"life":[235],"(EQ-5D-5L),":[236],"satisfaction":[238],"(Global":[239],"Assessment":[240],"Score,":[241],"GAS),":[242],"urodynamic":[243],"measures,":[244],"safety":[245],"monitoring,":[246],"stimulation":[249],"parameters.":[250],"will":[254,295,308],"be":[255,296],"analyzed":[256],"logistic":[258],"regression":[259],"secondary":[262],"linear":[265],"mixed":[266],"models;":[267],"subgroup":[268],"analyses":[269],"exploratory.":[271],"Assuming":[272],"success":[273],"rates":[274],"0.5":[276],"versus":[278],"0.15":[279],"(control),":[280],"27":[281],"patients":[282],"per":[283,293],"group":[284,294],"required":[286],"(power":[287],"0.8,":[288],"\u03b1":[289],"=":[290],"0.05);":[291],"30":[292],"(approximately":[298],"86":[299],"enrolled)":[300],"allow":[302],"dropouts.":[304],"Discussion":[305],"This":[306],"high-quality":[310],"on":[312,344],"well-defined":[316],"cohort":[318],"may":[320],"help":[321],"refine":[322],"patient":[323],"selection":[324],"define":[326],"role":[328],"management":[333],"dysfunction.":[338],"Trial":[339],"registration":[340],"ClinicalTrials.gov":[341],"NCT05380856.":[342],"Registered":[343],"19":[345],"May":[346],"2022.":[347]},"counts_by_year":[],"updated_date":"2026-11-10T11:39:43.021295","created_date":"2026-11-08T00:00:00"}