Intersphincteric Injected Silicone Biomaterial Implants: a Treatment for Faecal Incontinence

Introduction: The aim of this study was to evaluate the functional efficacy of intersphincteric injected silicone biomaterial (PTQ) in patients with faecal incontinence.

Method: Prospective study of 33 consecutively included patients (male-female ratio: 9:24); median age 53 years (range: 21-75 years) with faecal incontinence of varied aetiology. The PTQ was injected under general anaesthesia with antibiotic cover. All patients had anorectal manometry, endoanal ultrasonography and responded to faecal incontinence severity questionnaire (Wexner score) and SF-36 short-form health survey questionnaire before and 3 months postoperatively. At time of final follow-up, the continence status and quality of life questionnaire were reassessed.

Results: The mean follow-up was 12.9 months (range: 3-22 months). The Wexner Continence Score was significantly reduced short term from 12.7 to 11.0 (P = 0.03) and long term to 10.4 (P = 0.02). The long-term effect on liquid stool incontinence continued to improve significantly (P < 0.01). Six patients (18%) reported major improvement in Wexner Continence Score at the time of final follow-up. Anorectal manometry was not affected except for the maximum tolerable rectal volume, which was significantly reduced (P < 0.05). The SF-36 short-form questionnaire showed no significant improvement in quality of life after treatment with PTQ.

Conclusions: Treatment with intersphincteric injection of PTQ implants can provide an improvement in anal continence in patients with faecal incontinence of varied aetiology. However, the improvement is mainly limited to soiling and minor leakage. A majority of patients still have severe incontinence, both short- and long-term.