Efficacy of Sphinkeeper implantation in faecal incontinent patients: 1 year experience

Donisi L., Parello A., Litta F., Ratto C.
Colorectal disease, Volume 18, Supplement 1, September 2016

Aim of this study was to evaluate the efficacy of Sphinkeeper in the treatment of faecal incontinence.

Ten patients (5 female; median age 70 years [20-75]) met the inclusion sphincteric space of the middle-upper third of the anal canal, under endoanal ultra-sound guidance. Continence diary, FI scores, ability to defer defecation, need to wear pads, quality of life, endoanal ultrasound and anorectal manometry were assessed before and at follow-up.

No complication occurred. At 1 year follow-up there was a significant reduction of median weekly episodes of FI to soiling (7[0-49] vs. 0.5[0-7]; P<0.017), flatus (10.5[0-35] vs. 0.1 [0-14] P<0.028), liquid stool (1.8[0.21] vs 0 [0-14]; P<0.028), and solid stool (0[0-7] vs 0[0-0] P=0.068). Seven patients could not defer defecation for more than 5 min preoperatively, which reduced to three patients at follow-up. Median Wexner, Vaizey and AMS FI scores significantly decreased at f.up (10 [5-17] vs 4 [0-9] P= 0.012; 13 [7-19] vs 7 [0-11] P=0.012; 80 [26-114] vs 49 [0-86]; P=0.035). Two patients were fully continent.

Sphinkeeper seems to be a safe and effective approach to FI.