Abstract | OBJECTIVE: 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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Authors | Katleen Jottard, Sylvie Van den Broeck, Niels Komen, Luc Bruyninx, Stefan De Wachter |
Journal | Neuromodulation : journal of the International Neuromodulation Society
(Neuromodulation)
Vol. 24
Issue 7
Pg. 1284-1288
(Oct 2021)
ISSN: 1525-1403 [Electronic] United States |
PMID | 33107663
(Publication Type: Journal Article)
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Copyright | © 2020 International Neuromodulation Society. |
Topics |
- Electric Stimulation Therapy
- Fecal Incontinence
(therapy)
- Follow-Up Studies
- Humans
- Lumbosacral Plexus
- Quality of Life
- Treatment Outcome
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