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Five-Year Followup Results of a Prospective, Multicenter Study of Patients with Overactive Bladder Treated with Sacral Neuromodulation

2017; Lippincott Williams & Wilkins; Volume: 199; Issue: 1 Linguagem: Inglês

10.1016/j.juro.2017.07.010

1527-3792

Steven Siegel, Karen Noblett, Jeffrey Mangel, Jason Bennett, Tomas L. Griebling, Suzette E. Sutherland, Erin T. Bird, Craig V. Comiter, Daniel J. Culkin, Samuel Zylstra, Fangyu Kan, Kellie Chase Berg,

Sexual function and dysfunction studies

No AccessJournal of UrologyAdult Urology1 Jan 2018Five-Year Followup Results of a Prospective, Multicenter Study of Patients with Overactive Bladder Treated with Sacral Neuromodulation Steven Siegel, Karen Noblett, Jeffrey Mangel, Jason Bennett, Tomas L. Griebling, Suzette E. Sutherland, Erin T. Bird, Craig Comiter, Daniel Culkin, Samuel Zylstra, Fangyu Kan, and Kellie Chase Berg Steven SiegelSteven Siegel Metro Urology, Woodbury, Minnesota More articles by this author , Karen NoblettKaren Noblett University of California, Riverside, Riverside, California More articles by this author , Jeffrey MangelJeffrey Mangel MetroHealth Medical Center, Cleveland, Ohio More articles by this author , Jason BennettJason Bennett Female Pelvic Medicine, Grand Rapids, Michigan Financial interest and/or other relationship with Medtronic. More articles by this author , Tomas L. GrieblingTomas L. Griebling University of Kansas, Kansas City, Kansas More articles by this author , Suzette E. SutherlandSuzette E. Sutherland University of Washington, Seattle, Washington More articles by this author , Erin T. BirdErin T. Bird Scott and White Healthcare, Temple, Texas More articles by this author , Craig ComiterCraig Comiter Stanford University, Stanford, California More articles by this author , Daniel CulkinDaniel Culkin University of Oklahoma Health Science Center, Oklahoma City, Oklahoma More articles by this author , Samuel ZylstraSamuel Zylstra Milford Regional Medical Center, Whitinsville, Massachusetts More articles by this author , Fangyu KanFangyu Kan Medtronic, Minneapolis, Minnesota Financial interest and/or other relationship with Medtronic. More articles by this author , and Kellie Chase BergKellie Chase Berg Medtronic, Minneapolis, Minnesota Financial interest and/or other relationship with Medtronic. More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2017.07.010AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract Purpose: We evaluated the therapeutic success rate, changes in quality of life and safety of sacral neuromodulation 5 years after InterStim™ implantation. Included in study were subjects with bothersome symptoms of overactive bladder, including urinary urge incontinence and/or urgency-frequency, in whom at least 1 anticholinergic medication failed and 1 medication had not been tried. Materials and Methods: Therapeutic success was defined as a urinary urge incontinence or urgency-frequency response of 50% or greater improvement in average leaks or voids per day, or return to normal voiding, defined as fewer than 8 voids per day. Quality of life was evaluated by ICIQ-OABqol (International Consultation on Incontinence Modular Questionnaire). Safety was evaluated through adverse events. Results: Of the 340 subjects who completed the test stimulation 272 had an implant, of whom 91% were female. Mean age was 57 years. At baseline 202 subjects with urinary urge incontinence had a mean ± SD of 3.1 ± 2.7 leaks per day and 189 with urgency-frequency had a mean of 12.6 ± 4.5 voids per day. The 5-year therapeutic success rate was 67% (95% CI 60–74) using modified completers analysis and 82% (95% CI 76–88) using completers analysis. Subjects with urinary urge incontinence had a mean reduction from baseline of 2.0 ± 2.2 leaks per day and subjects with urgency-frequency had a mean reduction of 5.4 ± 4.3 voids per day (each completers analysis p <0.0001). Subjects showed improvement in all ICIQ-OABqol measures (p <0.0001). The most common device related adverse events were an undesirable change in stimulation in 60 of the 272 subjects (22%), implant site pain in 40 (15%) and therapeutic product ineffectiveness in 36 (13%). 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Google Scholar © 2018 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetailsCited byTilborghs S, Van de Borne S, Vaganée D, De Win G and De Wachter S (2020) A Supervised 3 Weeks Test Phase in Sacral Neuromodulation with a 1-Year FollowupJournal of Urology, VOL. 205, NO. 1, (206-212), Online publication date: 1-Jan-2021.Dorsthorst M, Digesu G, Tailor V, Gore M, van Kerrebroeck P, van Breda H, Elneil S and Heesakkers J (2020) 3-Year Followup of a New Implantable Tibial Nerve Stimulator for the Treatment of Overactive Bladder SyndromeJournal of Urology, VOL. 204, NO. 3, (545-550), Online publication date: 1-Sep-2020.Rueb J, Pizarro-Berdichevsky J and Goldman H (2020) 17-Year Single Center Retrospective Review of Rate, Risk Factors and Outcomes of Lead Breakage during Sacral Neuromodulation Lead RemovalJournal of Urology, VOL. 203, NO. 6, (1178-1183), Online publication date: 1-Jun-2020.Wein A (2019) Re: A Prospective, Multicenter Study of a Novel, Miniaturized Rechargeable Sacral Neuromodulation System: 12-Month Results from the RELAX-OAB StudyJournal of Urology, VOL. 203, NO. 3, (467-468), Online publication date: 1-Mar-2020.McCrery R, Lane F, Benson K, Taylor C, Padron O, Blok B, De Wachter S, Pezzella A, Gruenenfelder J, Pakzad M, Perrouin-Verbe M, Le Normand L, Van Kerrebroeck P, Mangel J, Peters K, Kennelly M, Shapiro A, Lee U, Comiter C, Mueller M and Goldman H (2019) Treatment of Urinary Urgency Incontinence Using a Rechargeable SNM System: 6-Month Results of the ARTISAN-SNM StudyJournal of Urology, VOL. 203, NO. 1, (185-192), Online publication date: 1-Jan-2020.Smith J (2017) This Month in Adult UrologyJournal of Urology, VOL. 199, NO. 1, (1-3), Online publication date: 1-Jan-2018. Volume 199Issue 1January 2018Page: 229-236 Advertisement Copyright & Permissions© 2018 by American Urological Association Education and Research, Inc.Keywordselectrodesimplantedurinary bladderoveractivequality of lifeurinary incontinenceMetricsAuthor Information Steven Siegel Metro Urology, Woodbury, Minnesota More articles by this author Karen Noblett University of California, Riverside, Riverside, California More articles by this author Jeffrey Mangel MetroHealth Medical Center, Cleveland, Ohio More articles by this author Jason Bennett Female Pelvic Medicine, Grand Rapids, Michigan Financial interest and/or other relationship with Medtronic. More articles by this author Tomas L. Griebling University of Kansas, Kansas City, Kansas More articles by this author Suzette E. Sutherland University of Washington, Seattle, Washington More articles by this author Erin T. Bird Scott and White Healthcare, Temple, Texas More articles by this author Craig Comiter Stanford University, Stanford, California More articles by this author Daniel Culkin University of Oklahoma Health Science Center, Oklahoma City, Oklahoma More articles by this author Samuel Zylstra Milford Regional Medical Center, Whitinsville, Massachusetts More articles by this author Fangyu Kan Medtronic, Minneapolis, Minnesota Financial interest and/or other relationship with Medtronic. More articles by this author Kellie Chase Berg Medtronic, Minneapolis, Minnesota Financial interest and/or other relationship with Medtronic. More articles by this author Expand All Advertisement PDF downloadLoading ...