Injectable silicone biomaterial (PTQ) is more effective than carbon-coated beads (Durasphere) in treating passive faecal incontinence--a randomized trial.
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.


METHODS
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.


CONCLUSIONS
In patients with internal sphincter dysfunction, injectable silicone biomaterial was safer and more effective than Durasphere.
Tjandra
J J
JJ
Department of Colorectal Surgery, Epworth Hospital, University of Melbourne, Melbourne, Victoria, Australia.
Chan
M K Y
MK
Yeh
H C H
HC
D000368:Aged; D001003:Anal Canal / Q000503:physiopathology*; D001672:Biocompatible Materials / Q000008:administration & dosage*; D005242:Fecal Incontinence / Q000209:etiology / Q000628:therapy*; D005260:Female; D005936:Glucans / Q000008:administration & dosage*; D006801:Humans; D007279:Injections, Subcutaneous; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D011788:Quality of Life; D020127:Recovery of Function; D012828:Silicones / Q000008:administration & dosage*; D015040:Zirconium / Q000008:administration & dosage*
D001672:Biocompatible Materials; D005936:Glucans; D012828:Silicones; C431745:durasphere; D015040:Zirconium