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Title: Injectable silicone biomaterial (PTQ) is more effective than carbon-coated beads (Durasphere) in treating passive faecal incontinence--a randomized trial.
Epworth Authors: Tjandra, Joe
Chan, Miranda
Yeh, Chung Hung
Keywords: Faecal Incontinence
Injectable Silicone Biomaterial
Pyrolytic Carbon Coated Beads
Sphincter Dysfunction
Anorectal Physiology
Endoanal Ultrasound
Biocompatible Materials
Wexner's Continence Score
Department of Colorectal Surgery, Epworth Hospital, Melbourne, Victoria, Australia
General Surgery and Gastroenterology Clinical Institute, Epworth HealthCare, Victoria, Australia
Issue Date: May-2009
Publisher: John Wiley & Sons
Citation: Colorectal Dis. 2009 May;11(4):382-9
Abstract: OBJECTIVE: Both injectable silicone biomaterial (PTQ) and pyrolytic carbon-coated beads (Durasphere) have been shown to be effective in treating passive faecal incontinence due to internal sphincter dysfunction. This is a randomized study to evaluate their relative safety and efficacy. METHOD: Forty patients (mean age 59.5 years vs 58.9 years) were randomized to have inter-sphincteric injection of PTQ or submucosal injection of Durasphere. Patients were assessed with anorectal physiology, endoanal ultrasound, a validated incontinence score and quality of life questionnaires. RESULTS: In the Durasphere group, complications included rectal pain (5%), erosion through rectal mucosa (10%), and type III hypersensitivity reaction (5%). No complications occurred in the PTQ group. Compared with PTQ, Durasphere group has a more rapid action, with improved continence at 2 weeks after injection. In both groups, faecal continence significantly improved 6 weeks after injection, and continued to improve significantly up to 6 months in both groups (P < 0.0001). At 6 weeks, 6 and 12 months after injection, significantly more PTQ patients achieved greater than 50% improvement in Wexner's continence score than Durasphere patients (respectively, P = 0.01; P < 0.0001; P = 0.001). There was a significant improvement in faecal incontinence quality of life scale and the 12-month physical health scale of Short Form-12 health survey in the PTQ group but not in the Durasphere group. CONCLUSION: In patients with internal sphincter dysfunction, injectable silicone biomaterial was safer and more effective than Durasphere.
DOI: 10.1111/j.1463-1318.2008.01634.x
PubMed URL:
ISSN: 1463-1318
Journal Title: Colorectal Disease
Type: Journal Article
Affiliated Organisations: University of Melbourne, Melbourne, Victoria, Australia
Type of Clinical Study or Trial: Randomized Clinical Trial
Appears in Collections:UroRenal, Vascular

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