{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,9]],"date-time":"2026-10-09T17:38:36Z","timestamp":1791567516852,"version":"4.3.4"},"reference-count":24,"publisher":"Wiley","license":[{"start":{"date-parts":[[2026,9,25]],"date-time":"2026-09-25T00:00:00Z","timestamp":1790294400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2026,9,25]],"date-time":"2026-09-25T00:00:00Z","timestamp":1790294400000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/100004374","name":"Medtronic","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004374","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Neurourology and Urodynamics"],"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>\n                      Sacral neuromodulation (SNM) therapy today relies on visually observed motor responses (e.g., anal bellows contraction, toe flexion) and subjective patient feedback (pelvic region sensations) to optimize lead placement and perform device programming. Measures of sacral nerve activation used in current practice include motor and sensory thresholds, described as the stimulation amplitudes associated with first observed or reported stimulation responses. This study evaluated the utility of\n                      <jats:italic>sacral evoked responses<\/jats:italic>\n                      (SERs), recorded directly from implanted commercial SNM leads, as objective indicators of sacral nerve activation.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Materials and Methods<\/jats:title>\n                    <jats:p>The PEER 2 Cohort 1 study was a multi\u2010center, prospective, clinical feasibility study in female overactive bladder patients undergoing a tined lead evaluation for SNM using InterStim\u2122 SureScan\u2122 MRI leads. An investigational external neurostimulator was used to collect electrophysiological signal recordings directly from the implanted lead (SER recordings), in addition to motor and sensory thresholds at three timepoints: intraoperatively (OR), immediately postoperatively (PO), and at the end of therapy evaluation (Trial End). SER recordings were processed to determine stimulation amplitudes associated with first detectable signal (SER threshold, SERT) and analyzed for comparison with the motor and sensory thresholds.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Lead\u2010recorded SERs were reliably detected across subjects and timepoints: OR: 100% (89\/89 subjects); PO 98.9% (87\/88 subjects); Trial End: 97.7% (86\/88 subjects). SERTs demonstrated statistically significant\n                      <jats:italic>correlation<\/jats:italic>\n                      with both\n                      <jats:italic>motor<\/jats:italic>\n                      and\n                      <jats:italic>sensory<\/jats:italic>\n                      thresholds across six bipolar electrode configurations (\n                      <jats:italic>R<\/jats:italic>\n                      \u2009=\u20090.46\u20130.92;\n                      <jats:italic>p<\/jats:italic>\n                      \u2009&lt;\u20090.001). Compared to sensory thresholds,\n                      <jats:italic>SERTs were a more sensitive measure<\/jats:italic>\n                      of sacral nerve activation, detected at or below sensory thresholds in 57%\u201384% of subjects. SERTs also exhibited\n                      <jats:italic>less variability<\/jats:italic>\n                      across repeated measurements compared to sensory thresholds (\n                      <jats:italic>p<\/jats:italic>\n                      \u2009&lt;\u20090.001). Replicate SERTs showed no change in 55.9% of subjects, whereas sensory thresholds showed no change in only 20.6% of subjects.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>\n                      The study results demonstrate that SERs recorded from SNM leads are\n                      <jats:italic>reliably detected<\/jats:italic>\n                      , clinically\n                      <jats:italic>relevant<\/jats:italic>\n                      ,\n                      <jats:italic>sensitive<\/jats:italic>\n                      , and\n                      <jats:italic>consistent<\/jats:italic>\n                      markers of sacral nerve activation, offering an objective\n                      <jats:italic>alternative to present\u2010day subjective measures<\/jats:italic>\n                      . Integrating lead\u2010sensed SERs may streamline SNM programming and lead placement, introducing a simplified and standardized measure for optimizing and delivering patient\u2010specific SNM therapy.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Clinical Trial Registration<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"http:\/\/ClinicalTrials.gov\">ClinicalTrials.gov<\/jats:ext-link>\n                      NCT05200923.\n                    <\/jats:p>\n                    <jats:p>Investigational device. Limited by Federal (U.S.) law to investigational use. The research system and sensing feature are not approved by the FDA or any other regulatory authority and are not for sale in the US or internationally.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/nau.70443","type":"journal-article","created":{"date-parts":[[2026,9,25]],"date-time":"2026-09-25T10:30:55Z","timestamp":1790332255000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Sensing in Sacral Neuromodulation: Objective, Individualized Stimulation Response Thresholds Directly From the Lead"],"prefix":"10.1002","author":[{"given":"Colin","family":"Goudelocke","sequence":"first","affiliation":[{"name":"Ochsner Medical Center Department of Urology New Orleans Louisiana USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Henry","family":"Ruiz","sequence":"additional","affiliation":[{"name":"DHR Health Urology Institute Edinburg Texas USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2667-6706","authenticated-orcid":false,"given":"Charles R.","family":"Powell","sequence":"additional","affiliation":[{"name":"Indiana University School of Medicine Indianapolis Indiana USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Sheyn","sequence":"additional","affiliation":[{"name":"University Hospitals Cleveland Ohio USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4674-2598","authenticated-orcid":false,"given":"Brian J.","family":"Linder","sequence":"additional","affiliation":[{"name":"Mayo Clinic Rochester Minnesota USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ketul","family":"Shah","sequence":"additional","affiliation":[{"name":"OhioHealth, Doctors Hospital Columbus Ohio USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gustavo","family":"Villegas","sequence":"additional","affiliation":[{"name":"DHR Health Urology Institute Edinburg Texas USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joseph","family":"Henderson","sequence":"additional","affiliation":[{"name":"University Hospitals Cleveland Ohio USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anne G.","family":"Sammarco","sequence":"additional","affiliation":[{"name":"University Hospitals Cleveland Ohio USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6072-4455","authenticated-orcid":false,"given":"Sarah J.","family":"Offutt","sequence":"additional","affiliation":[{"name":"Medtronic Pelvic Health Minneapolis Minnesota USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8224-1195","authenticated-orcid":false,"given":"David U.J.","family":"Keller","sequence":"additional","affiliation":[{"name":"Medtronic Pelvic Health Minneapolis Minnesota USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katie C.","family":"Bittner","sequence":"additional","affiliation":[{"name":"Medtronic Neurovascular Medical Sciences Irvine California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hank","family":"Bink","sequence":"additional","affiliation":[{"name":"Medtronic Pelvic Health Minneapolis Minnesota USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ivan","family":"Merlo","sequence":"additional","affiliation":[{"name":"Medtronic Clinical &amp; Regulatory Solutions Rome Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julia P.","family":"Slopsema","sequence":"additional","affiliation":[{"name":"Medtronic Pelvic Health Minneapolis Minnesota USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5429-3393","authenticated-orcid":false,"given":"Lisa Jungbauer","family":"Nikolas","sequence":"additional","affiliation":[{"name":"Medtronic Pelvic Health Minneapolis Minnesota USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,9,25]]},"reference":[{"key":"e_1_2_12_2_1","doi-asserted-by":"publisher","DOI":"10.1097\/JU.0000000000000309"},{"key":"e_1_2_12_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.autneu.2025.103337"},{"key":"e_1_2_12_4_1","doi-asserted-by":"publisher","DOI":"10.1111\/ner.12695"},{"key":"e_1_2_12_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/bju.14650"},{"key":"e_1_2_12_6_1","doi-asserted-by":"publisher","DOI":"10.1111\/ner.13117"},{"key":"e_1_2_12_7_1","doi-asserted-by":"publisher","DOI":"10.1111\/codi.15390"},{"key":"e_1_2_12_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.neurom.2023.07.002"},{"key":"e_1_2_12_9_1","doi-asserted-by":"publisher","DOI":"10.3389\/fnins.2021.712168"},{"key":"e_1_2_12_10_1","doi-asserted-by":"publisher","DOI":"10.1115\/1.4056945"},{"key":"e_1_2_12_11_1","doi-asserted-by":"publisher","DOI":"10.1111\/codi.14234"},{"key":"e_1_2_12_12_1","doi-asserted-by":"publisher","DOI":"10.1002\/nau.24648"},{"key":"e_1_2_12_13_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00192-010-1275-1"},{"key":"e_1_2_12_14_1","doi-asserted-by":"publisher","DOI":"10.1007\/s001920070005"},{"key":"e_1_2_12_15_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00192-002-1029-9"},{"key":"e_1_2_12_16_1","doi-asserted-by":"publisher","DOI":"10.1002\/nau.24425"},{"key":"e_1_2_12_17_1","doi-asserted-by":"publisher","DOI":"10.1111\/ner.13177"},{"key":"e_1_2_12_18_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.neurom.2024.08.001"},{"key":"e_1_2_12_19_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.neurom.2024.09.477"},{"key":"e_1_2_12_20_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpain.2024.104646"},{"key":"e_1_2_12_21_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.parkreldis.2025.108078"},{"key":"e_1_2_12_22_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.neurom.2021.09.001"},{"key":"e_1_2_12_23_1","doi-asserted-by":"publisher","DOI":"10.1111\/codi.14874"},{"key":"e_1_2_12_24_1","doi-asserted-by":"publisher","DOI":"10.1097\/sla.0b013e318269d493"},{"key":"e_1_2_12_25_1","doi-asserted-by":"publisher","DOI":"10.1002\/nau.23925"}],"container-title":["Neurourology and Urodynamics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/nau.70443","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/nau.70443","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/nau.70443","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,9,25]],"date-time":"2026-09-25T10:30:56Z","timestamp":1790332256000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/nau.70443"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,9,25]]},"references-count":24,"alternative-id":["10.1002\/nau.70443"],"URL":"https:\/\/doi.org\/10.1002\/nau.70443","archive":["Portico"],"relation":{},"ISSN":["0733-2467","1520-6777"],"issn-type":[{"value":"0733-2467","type":"print"},{"value":"1520-6777","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,9,25]]},"assertion":[{"value":"2025-10-31","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-09-07","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-09-25","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"nau.70443"}}