A New Way to Treat Fecal Incontinence

Fecal incontinence is the involuntary loss of bowel control.  The causes include nerve damage, a weakened anal sphincter muscle associated with aging, and rectal muscle damage. The condition is distressing, and probably affects more than 5.5 million Americans.  A new treatment has been approved by the FDA, and a pertinent clinical trial is reported in the journal Lancet.   

Injecting a bulking agent – a sterile gel - in the anal canal is increasingly used to treat fecal incontinence.  In this multicenter study the agent used was composed of dextranomer in stabilized hyaluronic acid; this is marketed as Solesta®, marketed by Oceana Therapeutics inc.

There were 206 adult patients in the study, who were randomly assigned to receive either trans-anal submucosal injections of Solesta or sham injections.  The effect on severity of fecal incontinence and quality of life was assessed based on 2-week diaries and clinical assessments.   A response to treatment was defined as a reduction in the number of fecal incontinence episodes by 50% or more.   

Over half the patients who received Solesta injections (52%) had a 50% or more reduction in the number of incontinence episode, compared with 22 patients (31%) who received the sham treatment injections.  The average increase in the number of incontinence-free days at 6 months was greater in the Solesta treatment group than in the sham treatment group, although no statistically significant difference was noted at 3 months.

During the study 128 treatment-related adverse events were recorded in the Solesta treatment group and 29 in the sham-treatment group.  There were two serious adverse events with Solesta – a rectal abscess and a prostatic abscess.

In a press release, the FDA concludes that “[Solesta] provides a minimally invasive treatment option for patients with fecal incontinence that does not respond to conservative therapies”.  Patients having continuing problems in spite of conservative treatment should ask their doctor about Solesta.