PURPOSE: Injectable silicone biomaterial (PTQ) is effective in the short-term in treating passive fecal incontinence due to a weak or disrupted internal anal sphincter, but long-term data is lacking. This is the largest randomized study with a long-term follow up in evaluating the optimal technique (ultrasound-guided vs palpation) to administer PTQ used to augment the internal anal sphincter.
METHODS: One hundred eighty nine females and thirty six males (median age 51 yrs) were randomized to have injectable silicone biomaterial into inter-sphincteric space guided by endoanal ultrasound (Group A; n =114) or by palpation (Group B; n = 111). All were performed as a day case with mild sedation. Patients were assessed with anorectal physiologic studies, a validated incontinence score and quality of life questionnaires. 128 (57%) patients had a prolonged pudendal nerve terminal motor latency (PNTML).
RESULTS: In both groups, fecal continence was significantly improved one month after injection, but continued to improve significantly up to 12 months in Group A and 6 months in Group B (p<0.001). At 12 months and 24 months post-injection, significantly more Group A patients achieved greater than 50 percent improvement in Wexner's continence score than Group B patients (respectively, 70% vs 48%, p=0.01; 63% vs 41%, p=0.01 ). At 24 months follow up, all domains of the fecal incontinence quality of life scale and global quality of life scores improved significantly in both groups. Resting anal pressures were increased in both groups, but with significantly greater increase in Group A. At 36 months follow up, there was a notable deterioration in function in both groups. Reinjection is safe and
effective. A prolonged PNTML had no effect on functional outcome in either group. One patient from Group B had an inter-sphincteric abscess which settled with antibiotics.
CONCLUSIONS: In patients with internal sphincter dysfunction, injectable silicone biomaterial was more effective if injected under endoanal ultrasound guidance (when compared with palpation technique). The results were sustained till 24 months, with a notable deterioration at 36 months.
Source: Original article