Novel bulking agent for faecal incontinence

Abstract

BackgroundVarious injectable bulking agents have been used for the treatment of faecal incontinence (FI). However, encouraging early results are not maintained over time. This study aimed to assess short- and medium-term results of a new bulking agent for the treatment of FI.MethodsThe Gatekeeper™ prosthesis comprises a thin solid polyacrylonitrile cylinder that becomes thicker, shorter and softer within 24 h after implantation. Fourteen patients with FI underwent treatment with Gatekeeper™ under local anaesthesia. Four prostheses were implanted in the intersphincteric space in each patient, under endoanal ultrasound guidance. Number of episodes of major FI, Cleveland Clinic FI score (CCFIS), Vaizey score, anorectal manometry, endoanal ultrasonography (EUS), health status and quality of life (Short Form 36 and Faecal Incontinence Quality of Life questionnaires) were assessed before and after treatment.ResultsMean(s.d.) follow-up was 33·5(12·4) months. There were no complications. There was a significant decrease in major FI episodes from 7·1(7·4) per week at baseline to 1·4(4·0), 1·0(3·2) and 0·4(0·6) per week respectively at 1-month, 3-month and last follow-up (P = 0·002). CCFIS improved significantly from 12·7(3·3) to 4·1(3·0), 3·9(2·6) and 5·1(3·0) respectively (P < 0·001), and Vaizey score from 15·4(3·3) to 7·1(3·9), 4·7(3·0) and 6·9(5·0) respectively (P = 0·010). Soiling and ability to postpone defaecation improved significantly, and patients reported significant improvement in health status and quality of life. At follow-up, manometric parameters had not changed and EUS did not demonstrate any prosthesis dislocation.ConclusionThe Gatekeeper™ anal implant seemed safe, reliable and effective. Initial clinical improvement was maintained over time, and follow-up data were encouraging. Copyright © 2011 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd.

Comparison of percutaneous tibial nerve stimulation and bulking agent injection (polyacrylonitrile) in treating fecal incontinence

“…31,34,36 The positioning of the implant near the anal verge rather than the anorectal junction seems to be important for maintaining a sufficient anal high-pressure zone. Ratto et al 32 did not observe any complications in patients treated with PI. We also did not observe any complications among our study groups but prosthesis migration and perianal abscess were reported after PI application in a previous case report.…”

“…37 A review of bulking agent injection studies revealed that improvements in FI score, FI frequency and quality of life are unrelated to injection techniques and area. 31,33,34,36 In the study by Ratto et al, 32 FI episodes and FI scores decreased from 7.1 to 1.0 and from 12.7 to 5.1, respectively. In addition, the authors reported significant increases in the deferral of defecation time, general health and quality-of-life scores.…”

“…30,31 Although this method has been used for 20 years to treat FI, the optimal agent, quantity of the agent, injection technique, injection area and number of injections have not been clearly defined. 32 In our study, thin, solid polyacrylonitrile cylinders, first used by Ratto et al, 32 were used as an implant material. This implant is thin and long (21 mm-1.2 mm) during the implantation and becomes shorter and thicker (17 mm-7 mm) within 24 hours after implantation (Figures 3a and 3b).…”

“…In a study that used PI, no change in the post-treatment anorectal physiological tests was observed. 16,31,32,33,34 We also believe that anorectal physiological tests are not necessary to assess a patient's symptoms after treatment and that a patient interview suffices.…”

Simultaneous Delorme's procedure and inter-sphinteric prosthetic implant for the treatment of rectal prolapse and faecal incontinence: Preliminary experience and literature review

“…After the dissected mucosa had been excised, the prolapse was pushed back through the anal canal and the sutures tied. Following the Delorme's procedure, 6 polyacrylonitrile prosthetic cylinders with memory shape were inserted in the intersphincteric space using a dedicated device (Gate Keeper™, THD, Correggio Italy) according to the original technique as is described elsewhere [10]. In brief, the application begun with 2-mm skin incisions at the 1,3, 5, 7, 9 and 11 o'clock positions in the perianal area, about 1e2 cm from the anal margin.…”