Injections of Dextranomer Gel in Stabilized Hyaluronic Acid Reduce Fecal Incontinence
DynaMed Weekly Update - Volume 6, Issue 12
Fecal incontinence is a common problem for which patients may be reluctant to seek treatment, and there has been little evidence to support any medical or surgical interventions. Local injections to narrow the anal canal have been investigated but have shown little efficacy to date (Cochrane Database Syst Rev 2010 May 12;(5):CD007959). However, a new randomized trial with 206 patients appears to show promise for this approach. Patients (mean age 61 years) with fecal incontinence for 1 year or more (at least 4 episodes per 2-week period) were randomized to transanal submucosal injections of a dextranomer gel (NASHA Dx) in stabilized hyaluronic acid vs. sham injection and were followed for 6 months. All patients were offered repeat treatment at 1 month if their symptoms had not improved and they were not experiencing persistent adverse effects. The primary outcome was treatment response, defined as ≥ 50% reduction in incontinence episodes.
At 6 months, the dextranomer gel group had a significantly higher rate of treatment response (52% vs. 31%, p = 0.0089, NNT 5) (level 1 [likely reliable] evidence). The mean increase in incontinence-free days per 2-week period was 3.1 days for the gel group vs. 1.7 days for the sham group (p = 0.0156), and the gel was associated with a trend toward greater reduction in number of incontinence episodes per 2-week period (median reduction 6 vs. 3, p = 0.09). Adverse event rates (including proctalgia, rectal hemorrhage and diarrhea) were higher in the gel group. There were no significant differences between groups in quality of life measures. After an additional 6 months of unblinded follow-up, 69.1% of the gel group were found to have at least a 25% reduction in incontinence episodes from baseline (Lancet 2011 Mar 19;377(9770):997).
For more information, see the Fecal incontinence topic in DynaMed.