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Title
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Treatment of fecal incontinence with a rechargeable sacral neuromodulation system : efficacy, clinical outcome, and ease of use-six-month follow-up
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Author
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Abstract
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| Objective Sacral neuromodulation is an effective treatment for fecal incontinence (FI) after conservative treatments have failed. A new rechargeable sacral neuromodulation system (r-SNM) includes a rechargeable implantable neurostimulator (INS). No data is available of the use of this technology in patients with fecal incontinence. Materials and Methods Fifteen patients with FI were implanted with the Axonics rechargeable SNM system in a single-stage implant procedure and prospectively followed. Primary outcome was fecal incontinence episodes at four weeks and six months measured with stools diary. Success was defined as at least 50% improvement of fecal incontinence episodes. Additionally, quality of life and ease of use were evaluated. Results At four weeks, 13 participants (87%) were test responders based on >= 50% reduction in FI episodes as documented on their bowel diary. Weekly FI episodes decreased from a median (25%-75% range) of 8 (5.8-20.3) at baseline to a median of 1.5 (0.4-4.5) at four weeks (p = 0.001), and 1.5 (0-2.6) at six months (p = 0.001), corresponding to 75% and 79% reduction in weekly FI episodes. Of the 13 subjects having >= 50% reduction in FI episodes at four weeks, 12 (PP = 92%) were therapy responders at six months. There were no unanticipated device or procedure-related adverse events. Mean time to recharge the system was 37 +/- 3 min once or twice per week. All patients were moderately or very satisfied with the system and its effect. Conclusions The r-SNM system provides safe and effective therapy in patients with FI at six months. |
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Language
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English
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Source (journal)
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Neuromodulation. - Oxford, 1998, currens
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Publication
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Hoboken
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Wiley
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2021
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ISSN
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1094-7159
[Print]
1525-1403
[Online]
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DOI
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10.1111/NER.13298
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Volume/pages
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24
:7
(2021)
, p. 1284-1288
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ISI
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000583777400001
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Pubmed ID
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33107663
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Full text (Publisher's DOI)
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Full text (publisher's version - intranet only)
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