Novel bulking agent for faecal incontinence

BACKGROUND: Various injectable bulking agents have been used for the treatment of\r\nfaecal incontinence (FI). However, encouraging early results are not maintained\r\nover time. This study aimed to assess short- and medium-term results of a new\r\nbulking agent for the treatment of FI.\r\nMETHODS: The Gatekeeper(™) prosthesis comprises a thin solid polyacrylonitrile\r\ncylinder that becomes thicker, shorter and softer within 24 h after implantation.\r\nFourteen patients with FI underwent treatment with Gatekeeper(™) under local\r\nanaesthesia. Four prostheses were implanted in the intersphincteric space in each\r\npatient, under endoanal ultrasound guidance. Number of episodes of major FI,\r\nCleveland Clinic FI score (CCFIS), Vaizey score, anorectal manometry, endoanal\r\nultrasonography (EUS), health status and quality of life (Short Form 36 and\r\nFaecal Incontinence Quality of Life questionnaires) were assessed before and\r\nafter treatment.\r\nRESULTS: Mean(s.d.) follow-up was 33·5(12·4) months. There were no complications.\r\nThere was a significant decrease in major FI episodes from 7·1(7·4) per week at\r\nbaseline to 1·4(4·0), 1·0(3·2) and 0·4(0·6) per week respectively at 1-month,\r\n3-month and last follow-up (P = 0·002). CCFIS improved significantly from\r\n12·7(3·3) to 4·1(3·0), 3·9(2·6) and 5·1(3·0) respectively (P < 0·001), and Vaizey\r\nscore from 15·4(3·3) to 7·1(3·9), 4·7(3·0) and 6·9(5·0) respectively (P = 0·010).\r\nSoiling and ability to postpone defaecation improved significantly, and patients \r\nreported significant improvement in health status and quality of life. At\r\nfollow-up, manometric parameters had not changed and EUS did not demonstrate any \r\nprosthesis dislocation.\r\nCONCLUSION: The Gatekeeper(™) anal implant seemed safe, reliable and effective.\r\nInitial clinical improvement was maintained over time, and follow-up data were\r\nencouraging.