Injectable silicone biomaterial for faecal incontinence due to internal anal sphincter dysfunction

Abstract

Background: A weak or disrupted internal anal sphincter can cause passive faecal incontinence. Conservative measures may help some patients but there is no simple surgical solution for those who fail conservative treatment. A successful technique using trans-sphincteric injection of a bulking agent to augment the internal anal sphincter was developed in a previous pilot study. Aim: To determine the clinical results and underlying physiological effects of biomaterial injection. Patients: Six patients (four males, median age 53 years (range 36-65)) with faecal incontinence to solid or liquid stool related to poor internal anal sphincter function, of varied aetiology, were recruited. Methods: Silicone based biomaterial injections were performed, under local anaesthesia, with antibiotic cover. Three injections were placed circumferentially, trans-sphincterically, entering away from the anal margin and injecting at or just above the dentate line. Anorectal physiological studies, endoanal ultrasound, a bowel symptom diary, a validated incontinence score, and quality of life questionnaires were completed before treatment and on completion of follow up. Results: At a median follow up of 18 months (range 15-19), five of six patients had marked symptom improvement. Faecal incontinence scores improved from a median of 14/24 (range 11-20) before to 8/24 (6-15) after injection. Short form-36 quality of life physical and social function scores improved from a median of 26/100 (5-33) to 79/100 (25-100) and from 10/100 (5-37) to 100/100 (50-100), respectively. There was a corresponding physiological increase in maximum anal resting and squeeze pressures. Ultrasound showed the Bioplastique to be retained in the correct position in the improved patients without migration. There were no complications. Conclusion: Trans-sphincteric injection of silicone biomaterial can provide a marked improvement in faecal incontinence related to a weak or disrupted internal anal sphincter. This is associated with improved sphincter function and quality of life.

Elastomer implants in faecal incontinence: a blind, randomized placebo‐controlled study

“…Moreover, its design was equivalent to a double-blind study because both patients and end point assessments were blinded to the treatment. This contrasts with previous nonblind 18,21,23 and non-placebo-controlled studies. 22 This point is of paramount importance as faecal incontinence is a functional complaint which cannot be objectively quantified.…”

“…Moreover, our patients were comparable, in terms of age and incontinence severity, to those of previous studies that reported a positive effect of PDMS. 18,[21][22][23] We cannot exclude that impaired EAS function may influence a low success rate for some patients but mean anal pressures during voluntary contraction remained at a normal level in the population study. With respect to the implant procedure, we used the same way of injection of PDMS implants than previous studies.…”

Novos tratamentos para a incontinência anal: injeção de silicone melhora a qualidade de vida em 35 pacientes incontinentes

“…Entre os métodos não cirúrgicos disponíveis, a injeção de agentes de preenchimento, particularmente o silicone, tem demonstrado ser uma opção eficaz em casos selecionados. [12][13][14][15] O objetivo do nosso estudo foi demonstrar os benefícios clínicos da utilização do silicone como agente de preenchimento no tratamento da incontinência anal, particularmente avaliando-se os parâmetros do índice de incontinência da Cleveland Clinic Florida (CCFSS) 16 …”

“…Entre os métodos não cirúrgicos disponíveis, a injeção de agentes de preenchimento, particularmente o silicone, tem demonstrado ser uma opção eficaz em casos selecionados. [12][13][14][15] …”

Tratamento da incontinência anal através da injeção transesfincteriana de silicone: correlação entre os resultados clínicos, ultra-sonográficos e de manometria anorretal, incluindo o índice de assimetria esfincteriana

“…156,157 Os primeiros trabalhos em que se utilizou o silicone injetável como agente de preenchimento incluíram um número pequeno de pacientes, cuja melhora clínica não se correlacionou diretamente à melhora dos parâmetros manométricos. 146,147 Subseqüentes estudos com um maior número de pacientes têm demonstrado o benefício do silicone como agente de preenchimento para o tratamento da incontinência anal, principalmente baseando-se nos parâmetros clínicos e avaliação da melhora da qualidade de vida. 158 No Brasil, a utilização do silicone como agente de preenchimento permanece restrito a centros especializados no tratamento da incontinência anal, fato este relacionado à pouca experiência com o produto em nosso meio, além do custo ser ainda elevado.…”