Fecal Incontinence Sphincter Augmentation Alaiyan Bilal MD Hadassah mt scopus
AUGMENTATION METHODS Injectables( Bulking agents) Radiofrequency
INJECTABLES Biomaterials Polytef, Autologous fat, GAX (glutaraldehyde cross-linked) collagen, PTQ implantstm, Durasphere, Coaptite, Zuidex is dextranomer hyaluronic acid copolymer
The ideal agent biocompatible, non-migratory, non-allergenic, nonimmunogenic, non-carcinogenic, easy to inject and produce durable results.
INJECTABLES The first report of the use of injectable bulking agents was in 1993 by Shafik - Polytetrafluroethylene (Teflon or Polytef) 11 patients with improvement in all. 1995 Shafik 14 autologous fat, good shortterm results In 1998 Kumar et al.8 used glutaraldehyde cross-linked collagen 17 pts 11 short term improvement.
INJECTABLES Bioplastique, the equivalent of the silicone-based urological product Macroplastique 10 pts 6 months effect. carbon-coated zirconium oxide beads (Durasphere 18 pts partial short term results. 2001 self-detaching cross-linked silicone microballoons with a biocompatible filler material
Mechanism of action augments the natural anal cushions encourages a better seal of the anal canal lumen at rest increases the length of the anal high pressure zone improvement in anal canal symmetry
ACYST or DURASPHERE FI Microscopic picture of pyrolitic carbon beads Each carbon bead is 212-500µm Suspension of carbon bead in a gel consisting of water and beta-d glucan.
Methods of injection Submucosal intersphincteric trans-sphincteric
Systematic Review: Route of Injection Increase complications with intersphincteric vs transphincteric and pereanal injection n=969
Lack of well-conducted, randomised, controlled trials from which the efficacy of anal bulking agents can be determined.
Dextranomer in stabilised hyaluronic acid Randomised, sham-controlled trial Patients from 8 US and 5 European centers 2006 2008 Patients randomly assigned to receive (2:1) either anal injection of NASHA Dx (active treatment) or sham treatment After 1 month, all patients with a CCFIS of 10 or more (and no persistent adverse effects) were offered a repeat procedure Graf at al. Lancet 2011
Dextranomer in stabilised hyaluronic acid Randomised, sham-controlled trial 206/278 were randomly assigned to receive either active or sham treatment A 50% or greater reduction in the number of incontinence episodes: 71 (52%) patients in the active treatment group 22 (31%) patients in the sham treatment group Odds ratio 2.36, 95% CI 1 24 4 47, p=0.009). Graf at al. Lancet 2011
Dextranomer in stabilised hyaluronic acid Randomised, sham-controlled trial Improved QOL Graf at al. Lancet 2011
long-term efficacy and safety of NASHA/Dx, assessed 24 months after treatment. Long-term efficacy of dextranomer in stabilized hyaluronic acid (NASHA/Dx) for treatment of faecal incontinence F. La Torre* and F. de la Portilla *Department of Colorectal and Pelvic Surgery, 1st College of Medicine SAPIENZA, Rome University, Rome, Italy and Coloproctology Unit, Department of General Surgery, Hospital Universitario Virgen del Rocıo, Seville, Spain Received 11 July 2012; accepted 15 December 2012; Accepted Article online 1 February 2013 ª 2013 The Authors Colorectal Disease ª 2013 The Association of Coloproctology of Great Britain and Ireland. 15, 569 574
Results 62.7% - responders 50% reduction in FI episodes. The median number of FI episodes declined by 68.8% (P < 0.001). incontinence free days increased from 14.6 to 21.7 at 24 months (P < 0.001). quality of life scores also showed significant improvements.
Conclusion NASHA/Dx is safe, effective and durable over a 24-month period
Long-term evaluation of bulking agents for the treatment of fecal incontinence: clinical outcomes and ultrasound evidence F. Guerra M. La Torre G. Giuliani D. Coletta S. Amore Bonapasta F. Velluti F. La Torre Tech Coloproctol (2015) 19:23 27
Methods median follow-up of 7 years, 19 patients with idiopathic fecal incontinence who had received bulking agent implants were evaluated. BA - Durasphere, PTQ and Solesta subcut. were used. Clinical, manometric and ultrasound assessments were carried out.
methods Median follow-up of 7 years 19 patients with idiopathic fecal incontinence who had received bulking agent implants were evaluated. Clinical, manometric and ultrasound assessments were carried out.
Conclusions In the long term, perianally injected bulking agents seem to lose effectiveness.. The ultrasound assessment suggests that the process of resorption is almost complete, and the implants are no longer effective in treating incontinence.
Author Results of Injectables N Shafik et al. 14 Material used Autologous Fat Follow -up (month s) Wexner Incontinence score Before After 24 85% improved Shafik et al. 11 PTFE 24 63% improved Malouf et al. 10 Bioplastique 6 30% improved Tjandra et al. 82 Silicone 12 50% improved Tjandra et al. 20 PTQ 12 12 4 Sorensen et al. 33 Silicone 12 13 10 Weiss et al. 10 ACYST 22 13 10
Results of Injectables Davis et al. 18 Dursphere 29 11.8 8 Chan et al. 7 PTQ 14 9-14 1-5 Stojkovic et al. 73 Contigen 12 10 6 De la Portilla et al. 20 PTQ 24 13.5 9.4 Maeda et al. 10 Bulkamid 15 12 Permacol 19 16 15 Schwander et al. 21 Hyarulonic 20 17 12
Systematic Review of Perianal implants Agent No. of studi es Morbid ity (%) n=103 0 Short term success n=458 Long term success n=564 % n % n PTQ 21 10.2 75.8 277 63.4 380 Durasphere 7 24.4 53.3 62 43 40 NASHA TM 4 4.6 44.6 34 - - Permacol 3 0 82 34 100 4 Bulkamid TM 1 0 100 504 0 4 Coaptite 1 0 80 96 - - Hussain et al BJS 2011 Fat 2 0 100 14 100 14
Conclusions: bulking agents Simple Ambulatory Mild - Moderate to severe incontinence Good short term outcome Minimal complications
Radiofrequency (SECCA TM ) Temperature-controlled radiofrequency delivery
Radiofrequency (SECCA TM )
Radiofrequency (SECCA TM )
Results of Radiofrequency Author (year) n F/U (months) Wexner Score Before After QOL Takahashi 2002 10 12 13.5 5 Efron 2003 50 6 14.5 11 Takahashi 2003 10 24 13.8 7 Felt-Bersma 2007 11 12 18.8* 15* Takahashi 2008 19 60 14.4 8 Lefebure 2008 15 12 14.7 12.3 ** Kim 2009 8 6 13.6 9.9 - Walega 2009 20 6 Improved Ruiz 2010 16 12 15.6 12 Herman 2011 40 12 16 10.9 Abbas 2012 27 36 Only 22% improved -- * Vaizey score ** only depression improved
Results: Complications Adverse Event n % Mucosal Ulcerations 2 4 % Bleeding Requiring Intervention 12 % Minor Bleeding 5 10 % Antibiotic Induced Diarrhea 7 14 % Fever 2 4 % Vomiting 1 2 % Constipation 1 2 % Groin swelling 1 2 % Hot flashes 1 2 % Efron et al, DCR 2003
Secca - Conclusions Ambulatory Simple Relatively safe Variable results