Three-year Follow-up Results of a Prospective, Multicenter Study in Overactive Bladder Subjects Treated With Sacral Neuromodulation.
Objective: To evaluate the therapeutic success rate, and changes in quality of life (QOL) and safety in subjects using sacral neuromodulation (InterStim System) at 36 months. Subjects with bothersome symptoms of overactive bladder (OAB) including urinary urge incontinence (UI) and/or urgency frequen...
| Published in: | Urology Vol. 94; no. 1; pp. 57 - 64 |
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| Main Authors: | , , , , , , , , , , , |
| Format: | research Journal Article |
| Published: |
Elsevier B.V.
Aug2016
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| Online Access: | View this record in EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=117753254&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 117753254 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 00904295 1YG jtl: Urology issn: 00904295 maglogo: N pubinfo: dt: Aug2016 vid: 94 iid: 1 pid: 467 pub: Elsevier B.V. place: New York, New York artinfo: ui: 117753254 117753254 NLM27131966 117753254 10.1016/j.urology.2016.04.024 NLM27131966 117753254 ppf: 57 ppct: 7 formats: tig: atl: Three-year Follow-up Results of a Prospective, Multicenter Study in Overactive Bladder Subjects Treated With Sacral Neuromodulation. aug: au: Siegel, Steven Noblett, Karen Mangel, Jeffrey Griebling, Tomas L. Sutherland, Suzette E. Bird, Erin T. Comiter, Craig Culkin, Daniel Bennett, Jason Zylstra, Samuel Kan, Fangyu Thiery, Elizabeth affil: Metro Urology, Woodbury, MN sug: subj: Electrotherapy Electrodes, Implanted Overactive Bladder Therapy Middle Age Lumbosacral Plexus Treatment Outcomes Time Factors Human Male Female Prospective Studies Quality of Life Urge Incontinence Therapy Validation Studies Comparative Studies Evaluation Research Multicenter Studies Ferrans and Powers Quality of Life Index Questionnaires Middle Aged: 45-64 years Male Female ab: Objective: To evaluate the therapeutic success rate, and changes in quality of life (QOL) and safety in subjects using sacral neuromodulation (InterStim System) at 36 months. Subjects with bothersome symptoms of overactive bladder (OAB) including urinary urge incontinence (UI) and/or urgency frequency (UF), who had failed at least 1 anticholinergic medication, and had at least 1 untried medication were included.Methods: Subjects with successful test stimulation received an InterStim implant. Therapeutic success and quality of life through 36 months was evaluated in implanted subjects with data at baseline and follow-up. Safety was evaluated using reported adverse events.Results: A total of 340 subjects received test stimulation resulting in 272 implanted subjects. Demographics include 91% female, mean age of 57 years, and baseline symptom severity of 3.1 ± 2.7 leaks/day (UI) and 12.6 ± 4.5 voids/day (UF). The analysis showed an OAB therapeutic success rate of 83% (95% confidence interval: 78%-88%). UI subjects had a mean reduction from baseline of 2.3 ± 2.3 leaks/day whereas UF subjects had a mean reduction of 5.3 ± 4.0 voids/day (both P < .0001). Statistically significant improvements were observed in all measures of the International Consultation on Incontinence Modular Questionnaire-OABqol (all P < .0001). Eighty percent of subjects reported improvements in their urinary symptom interference. Device-related adverse events occurred in 47% (127/272) of subjects post-implant; 91% were resolved at the time of this analysis.Conclusion: The 36-month follow-up data from the multicenter study demonstrate sustained safety, effectiveness, and improved QOL in subjects implanted with InterStim, without requiring failure of all medications. pubtype: Academic Journal doctype: research Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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