{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,2]],"date-time":"2026-06-02T07:13:36Z","timestamp":1780384416675,"version":"3.54.1"},"reference-count":27,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2019,7,3]],"date-time":"2019-07-03T00:00:00Z","timestamp":1562112000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Neurourology and Urodynamics"],"published-print":{"date-parts":[[2019,9]]},"abstract":"<jats:sec><jats:title>Aims<\/jats:title><jats:p>To compare the efficacy and safety of a neuromuscular external electrical stimulation device (INNOVO; \u201cNMES\u201d) with an FDA\u2010approved intravaginal device (iTouch sure; \u201ccomparator device\u201d) for the treatment of stress urinary incontinence (SUI).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This prospective, single\u2010blind, multicenter, noninferiority study randomized women with SUI to treatment with the NMES or the comparator device for 12 weeks. The primary endpoint was the proportion achieving &gt;50% reduction in pad weight from baseline to 12 weeks in the provocative pad weight test.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Most subjects in both groups achieved &gt;50% reduction in pad weight in the provocative pad test at week 12 (NMES 56.3%; comparator 63.0%), although noninferiority was not established. Significant improvements in pad tests, number of incontinence episodes, and pads used per day, and incontinence quality of life score were seen with both devices at week 12, with no clinically relevant between\u2010group differences. Adverse events were predominantly mild\/moderate and there were few discontinuations due to adverse events. The incidence of urinary tract\/vaginal infections was higher with the comparator device than the NMES (7.7% versus 0%). The most common device\u2010related adverse effect with the NMES was device discomfort (9.0%), which was generally manageable by modifying the stimulation intensity.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>The NMES significantly improved objective and subjective measures of SUI, although statistical noninferiority was not established. The NMES was well tolerated and associated with fewer urinary tract infections than the comparator. The NMES provides a safe, clinically effective, conservative treatment option for female SUI and a low\u2010risk alternative to intravaginal devices.<\/jats:p><\/jats:sec>","DOI":"10.1002\/nau.24066","type":"journal-article","created":{"date-parts":[[2019,7,4]],"date-time":"2019-07-04T04:14:48Z","timestamp":1562213688000},"page":"1834-1843","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":31,"title":["External electrical stimulation compared with intravaginal electrical stimulation for the treatment of stress urinary incontinence in women: A randomized controlled noninferiority trial"],"prefix":"10.1002","volume":"38","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9838-9178","authenticated-orcid":false,"given":"Roger","family":"Dmochowski","sequence":"first","affiliation":[{"name":"Department of Urologic Surgery Vanderbilt University  Nashville Tennessee"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Catherine M.","family":"Lynch","sequence":"additional","affiliation":[{"name":"Division of General Obstetrics and Gynecology The University of South Florida  Tampa Florida"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mitchell","family":"Efros","sequence":"additional","affiliation":[{"name":"Department of Urology AccuMed Research Associates  Garden City New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Linda","family":"Cardozo","sequence":"additional","affiliation":[{"name":"Department of Urogynaecology King's College Hospital  London United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2019,7,3]]},"reference":[{"key":"e_1_2_8_1_2_1","doi-asserted-by":"publisher","DOI":"10.1007\/s001920070021"},{"key":"e_1_2_8_1_3_1","doi-asserted-by":"publisher","DOI":"10.3310\/hta14400"},{"key":"e_1_2_8_1_4_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1464-410X.2005.05722.x"},{"issue":"5","key":"e_1_2_8_1_5_1","first-page":"CD005654","article-title":"Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women","volume":"14","author":"Dumoulin C","year":"2014","journal-title":"Cochrane Database Syst Rev"},{"key":"e_1_2_8_1_6_1","doi-asserted-by":"publisher","DOI":"10.1093\/ptj\/85.3.269"},{"key":"e_1_2_8_1_7_1","doi-asserted-by":"publisher","DOI":"10.1055\/s-0035-1571252"},{"key":"e_1_2_8_1_8_1","doi-asserted-by":"publisher","DOI":"10.1590\/1806-9282.63.07.642"},{"key":"e_1_2_8_1_9_1","first-page":"CD012390","article-title":"Electrical stimulation with non\u2010implanted devices for stress urinary incontinence in women","volume":"12","author":"Stewart F","year":"2017","journal-title":"Cochrane Database Syst Rev"},{"key":"e_1_2_8_1_10_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.318.7182.487"},{"key":"e_1_2_8_1_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/0002-9378(95)90172-8"},{"key":"e_1_2_8_1_12_1","doi-asserted-by":"publisher","DOI":"10.1590\/S1677-5538.IBJU.2013.04.02"},{"issue":"1","key":"e_1_2_8_1_13_1","first-page":"s22","article-title":"The efficacy of a new pelvic floor neuromuscular electrical stimulator compared to a sham modified version in eliciting pelvic floor muscle contractions in healthy female subjects \u2010 a validation study using ultrasound imaging","volume":"24","author":"Maher RA","year":"2013","journal-title":"Int Urogynecol J"},{"issue":"1","key":"e_1_2_8_1_14_1","first-page":"18","article-title":"A comparison of two methods of neuromuscular electrical stimulation delivery on pelvic floor muscle contraction in healthy subjects","volume":"34","author":"Maher RM","year":"2010","journal-title":"JWHPT"},{"key":"e_1_2_8_1_15_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1525-1403.2012.00509.x"},{"issue":"1","key":"e_1_2_8_1_16_1","first-page":"87","article-title":"How do pelvic floor muscle contractions elicited by 2 different delivery methods of neuromuscular electrical stimulation compare with volitional contractions in supine and standing in nulliparous continent women?","volume":"42","author":"Maher RM","year":"2018","journal-title":"JWHPT"},{"key":"e_1_2_8_1_17_1","volume-title":"Neuromuscular electrical stimulation (NMES) of the pelvic floor muscles using a non\u2010invasive surface device in the treatment of stress urinary incontinence (SUI); a pilot study [poster 388]","author":"Soeder S","year":"2013"},{"key":"e_1_2_8_1_18_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1471-0528.2004.00211.x"},{"key":"e_1_2_8_1_19_1","unstructured":"TensCare Ltd.itouch sure: instructions for use. 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