Background The bulking agent NASHA Dx injected into the submucosal layer is effective in the treatment of fecal incontinence (FI) at short-and medium-term follow-up but efficacy after injection in the intersphincteric location is unknown. The aim of this study was to determine the short- and long-term efficacy and safety of NASHA Dx injected into the intersphincteric location for FI. Methods Patients were recruited from referrals to our Department for treatment of FI in November 2008–January 2010. Eligible patients were injected with 8 ml of NASHA Dx. Patients with a subtotal treatment effect were retreated after 2–4 weeks. The change in number of fecal incontinence episodes, the proportion of responders defined as at least 50% decrease in number of FI episodes and side effects were the main outcome measures. Results Sixteen patients, 15 women and 1 man with a median age of 68, 5 (range 44–80) years and a median CCFIS of 15 (range 10–19) were included in the study. The median number of incontinence episodes decreased from 21.5 (range 8–61) at baseline to 10 (range 0–30) at 6 months (p = 0.003) and 6 (range 0–44) at 12 months (p = 0.05). The median number of incontinence episodes in the 11 patients completing the 10-year follow-up was 26.5 (range 0–68). The percentage of responders at 12 months and 10 years were 56% and 27%, respectively. Mild to moderate pain at the injection site was described by 69%. There was one case of mild infection, successfully treated with antibiotics and one implant had to be removed due to dislocation. Conclusions NASHA Dx as an intersphincteric implant improves incontinence symptoms in the short term with moderate side effects and can be used alone or as an adjunct to other treatment modalities. Long-term efficacy was observed in 27%.
Aim Lead migration is a common cause of loss of efficacy in sacral nerve modulation. Our aim was to systematically study the migration pattern of tined leads in sacral nerve modulation. Our hypothesis was that tined leads may promote forward migration because of their configuration. Method Consecutive patients treated with sacral nerve modulation with a tined lead electrode, who had experienced loss of efficacy and had radiographs both at baseline and after loss of efficacy between 2005 and 2016 were eligible for inclusion. Results Twenty-five patients out of 70 with loss of efficacy were studied. Lead migration was measured as percent electrode movement in relation to sacral cortex at lateral projection. All had some degree of lead migration, ranging from 35% backward to 74% forward migration. Sixteen (64%) had forward migration while nine (36%) had backward migration. In seven patients (28%), loss of efficacy was associated with an episode of perceived mechanical strain on the electrode. Fifty percent (4/8) who associated their loss of efficacy with an adverse event had forward migration of the electrode. Conclusions Forward lead migration with concomitant loss of efficacy seems to be a common event in patients with tined leads, hence supporting our hypothesis. The retrospective design and that some of the patients with loss of efficacy could not be included because of incomplete data, which is a limitation to the study. Further studies are needed to confirm to what extent the direction and magnitude of the migration relate to loss of efficacy. Trial registration
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